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Canadian Journal of Anesthesia 53:899-905 (2006)
© Canadian Anesthesiologists' Society, 2006
Regional Anesthesia and Pain

Epidural dexamethasone reduces postoperative pain and analgesic requirements

[L’administration péridurale de dexaméthasone réduit la douleur et la demande d’analgésiques postopératoires]

Siji Thomas, MD and Suhara Beevi, MD

From the Department of Anaesthesiology, Amala Institute of Medical Sciences, Thrissur, Kerala, India.

Address correspondence to: Dr. Siji Thomas, G/ 04, Chaithanya, Amala Institute of Medical Sciences, Thrissur, Kerala - 680555, India. Phone: +91(0)-9895811263; Fax: +91(0)-4872308919; E-mail: sijithomas2k{at}yahoo.com


   Abstract
TOP
 Abstract
Introduction
 Methods
 Results
 Discussion
 References
 
Purpose: Epidural steroids may have potential advantages for providing postoperative analgesia. We therefore undertook a study to evaluate the efficacy of epidurally administered dexamethasone in reducing postoperative morphine requirements, as a measure of analgesia following laparoscopic cholecystectomy.

Methods: In a randomized, double-blind study, 94 patients undergoing laparoscopic cholecystectomy were randomly assigned to one of three groups. Group 1 (Control) patients received dexamethasone 5 mg iv with epidural injection of 0.25% bupivacaine 8 mL and normal saline 2 mL, Group 2 (D1) patients received normal saline 2 mL iv with epidural injection of 0.25% bupivacaine 8 mL and dexamethasone 5 mg in normal saline 2 mL, and Group 3 (D2) patients received normal saline 2 mL iv with epidural injection of dexamethasone 5 mg in normal saline 10 mL. After surgery, morphine 2–4 mg iv was administered as needed for analgesia. Postoperative morphine requirements, visual analogue scale (VAS) pain scores at rest and with effort, and time to first analgesic administration were recorded by a blinded observer.

Results: Total morphine consumption for the first 24 hr following surgery was lower in both epidural dexamethasone groups (D1, D2) compared to the control group (P < 0.05). The percentage reduction in morphine consumption in Group D1 was 53.9% and in Group D2 was 52.9% in the first 24 hr. Postoperatively at 12 hr, 18 hr and 24 hr, the VAS scores at rest and during effort were also lower in the epidural dexamethasone groups (D1, D2) compared to the control group (P < 0.05). The percentage reductions in VAS scores with effort at 12 hr, 18 hr and 24 hr in Group D1 were 50%, 52.9% and 50% respectively, and in Group D2 percentage reductions in pain scores with effort were 54.8%, 58.8% and 55.5% at corresponding sampling intervals.

Conclusion: Preoperative epidural administration of dexamethasone 5 mg, with or without bupivacaine, reduces postoperative pain and morphine consumption following laparoscopic cholecystectomy.


   Introduction
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 Abstract
 Introduction
Methods
 Results
 Discussion
 References
 
BENEFITS of laparoscopic cholecystectomy as compared to open cholecystectomy are well-established, and include shorter hospitalization, earlier return to work, better hospital bed utilization, and reduced costs.1 Despite these benefits, postoperative pain remains the dominant complaint after laparoscopic cholecystectomy, and has great potential to be influenced by the anesthesiologist.2

The common analgesic modalities after laparoscopic cholecystectomy include non-steroidal anti-inflammatory drugs, wound infiltration with local anesthetics, and intraperitoneal administration of local anesthetics or saline, producing short-term benefits that do not necessarily translate into earlier discharge or improved postoperative function.3 Opioids provide good pain control in the postoperative period, but are associated with nausea and vomiting, sedation, pruritus and respiratory depression. As no single drug has been identified which specifically inhibits nociception without side effects, multimodal analgesic strategies are most commonly employed for postoperative analgesia. Trials evaluating multimodal analgesia in laparoscopic cholecystectomy suggest that clinically relevant benefits can be achieved.3 Thoracic epidural analgesia with morphine-bupivacaine combination improves pain relief during the first 24 hr following laparoscopic cholecystectomy.4

Preoperative administration of dexamethasone has been reported to reduce postoperative pain through both oral5,6 and iv7,8 routes of administration. While epidural steroids are effective in the treatment of low back pain,9 their potential postoperative analgesic benefits have not been evaluated. The safety of epidural steroid injections has been demonstrated.10,11 Although arachnoiditis has been reported in association with accidental intrathecal injection of depo-steroids12,13 this risk is considered to be minimal with dexamethasone as a result of its water-solubility.

Acute nociception at peripheral tissues leads to intraspinal prostaglandin synthesis by induction of cyclo-oxygenase-2 and activation of phospholipase A2, resulting in a hyperalgesic state.14,15 Corticosteroids are known to inhibit phospholipase A2 and expression of cyclo-oxygenase-2 during inflammation, thus reducing prostaglandin synthesis.16 Intrathecal injection of corticosteroids in the rat model has been shown to have no effect on acute high intensity stimuli, despite a mild effect on nociceptor driven spinal sensitization.14

With this background knowledge, a randomized, double-blind study was undertaken to test whether a reduction in postoperative pain and morphine consumption could be achieved by preoperative administration of epidural dexamethasone, in patients undergoing laparoscopic cholecystectomy.


   Methods
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 Abstract
 Introduction
 Methods
Results
 Discussion
 References
 
After approval from local Ethics Committee and obtaining written informed consent, 94 patients of either sex undergoing laparoscopic cholecystectomy were enrolled in this prospective, randomized, double-blinded study. Included were ASA class I and II patients, between 30–60 yr of age and weighing between 50–75 kg. Patients were excluded if they had any history of cardiac, respiratory, neuromuscular, hepatic or major renal disease. Patients were also excluded if they were obese, diabetic, or if they were receiving analgesics, corticosteroids or calcium channel blocking drugs. Finally, any contraindication to corticosteroids, or failure of the patient to understand the study procedure, resulted in their exclusion.

The study protocol, the epidural procedure, and the visual analogue scale (VAS) for pain were explained to each patient during the preoperative visit. Patient randomization was established with the use of computer-generated codes. Only the pharmacist and the statistician knew the identity of the study medication. Procedures were established to break the codes in the event of any adverse reaction. Group 1 (Control) patients received dexamethasone 5 mg iv with epidural injection of 0.25% bupivacaine 8 mL and normal saline 2 mL, Group 2 (D1) patients received normal saline 2 mL iv with epidural injection of 0.25% bupivacaine 8 mL and dexamethasone 5 mg in normal saline 2 mL, and Group 3 (D2) patients received normal saline 2 mL iv with epidural injection of dexamethasone 5 mg in normal saline 10 mL. The dexamethasone formulation was Decdan 4 mg·mL–1 (Merind, Mumbai, India) with methyl-and propyl paraben preservatives. The final concentration for each group was established by mixing with the appropriate volume of normal saline.

On the day of surgery, patients were premedicated with midazolam 7.5 mg po 60 min preoperatively. In the operating room routine monitors were applied (electrocardiogram, non-invasive blood pressure monitor and pulse oximeter). Patients were awake during thoracic epidural insertion. With the patient sitting and under aseptic conditions, the skin was infiltrated with 1% lidocaine 3 mL prior to insertion of an 18G Tuohy needle at the T7–8 interspace. Upon establishing loss of resistance to air, a test dose of 2% lidocaine 3 mL with adrenaline 1:200000 was injected after negative aspiration. Five minutes later, patients were randomly allocated to receive a single-shot epidural injection and simultaneous iv injection according to group assignment.

Anesthesia was induced with propofol 2 mg·kg–1 iv and fentanyl 2 µg·kg–1 iv, with endotracheal intubation facilitated by vecuronium 0.1 mg·kg–1 iv. The patient’s lungs were mechanically ventilated with N2O:O2 (1:1) and isoflurane (0.7–1% end-tidal concentration) to maintain normocarbia. Intraoperatively the following variables were monitored: mean arterial pressure (MAP), heart rate (HR), arterial oxygen saturation (SpO2), end tidal carbon dioxide (EtCO2), airway and intra-abdominal pressures pre-and post-induction, and every 15 min thereafter until the end of surgery. A clinical response to intraoperative surgical stimulation was defined as an increase in either HR or MAP > 30% of baseline values after induction, and was treated with fentanyl 1 µg·kg–1 iv boluses until restoration of hemodynamic parameters to baseline values. Muscle relaxation was maintained by appropriate doses of vecuronium until removal of the gallbladder. At the end of surgery, ondansetron 6 mg iv was administered, and residual neuromuscular block was antagonized with neostigmine and atropine. The cumulative dose of fentanyl and the time of the last fentanyl supplement before the end of surgery were recorded. In the postanesthesia care unit, quality of analgesia was assessed by a second trained observer who, along with the patient, was blinded to study group assignment. The VAS scores (linear 10 mm, starting from 0 = no pain to 10 = worst pain imaginable) were recorded at rest and with effort (coughing and at 30° sitting) 30 min postoperatively, and then at six hours intervals for 24 hr. After each VAS scoring interval, patients were asked if they required additional analgesia regardless of their VAS score. Patients were also instructed to request pain medication from the nurse whenever they required pain relief, and not to wait for their next scheduled pain assessment. Morphine 2–4 mg iv was titrated to patient comfort. No other analgesics or sedative medications were allowed for 24 hr after surgery. Diphenhydramine 25 mg im prn and metoclopramide 10 mg im prn were prescribed for itching and nausea/vomiting, respectively. The total amount of morphine administered, time to first morphine dose after surgery, hemodyanamic variables (MAP, HR, SpO2) and occurrence of any intra-or postoperative adverse events, including, but not limited to itching, nausea/vomiting, respiratory depression (defined as respiratory rate < 12 per min), and radicular irritation orded.

Sample size calculation was based upon the variability of total morphine consumption during the first 24 hr postoperatively from 105 consecutive patients who had undergone uncomplicated laparoscopic cholecystectomy, receiving a similar anesthetic and analgesic treatment. Assuming {alpha} = 0.05, and with standard deviation of the primary outcome measure of 5.5 mg, 30 patients per group were required to detect a difference of morphine consumption, within 2 mg (with 5% precision) of the population mean. Inter-group comparisons of demographic data were done using a Student’s t test. Parametric data were compared by one-way analysis of variance (ANOVA) followed by Student’s t test, and non-parametric data were analyzed with the Mann-Whitney U test. Results are expressed as mean ± SD. A value of P < 0.05 was considered statistically significant.


   Results
TOP
 Abstract
 Introduction
 Methods
 Results
Discussion
 References
 
Of the 94 patients studied, four patients were excluded from the analysis, two from Group 1 and one from Group D1 because of protocol violation and one patient in Group D2 who was converted to open cholecystectomy. Patient characteristics in the remaining 90 patients were comparable with respect to age, weight and duration of surgery (Table IGo).


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  		TABLE I Demographic data
 
Cumulative intraoperative fentanyl requirements and timing of the last fentanyl dose were similar in all three groups. Times to first administration of morphine in the postoperative period were also similar amongst groups. The cumulative dose of morphine administered over 24 hr was lower in patients who received epidural dexamethasone (Groups D1, D2) compared with the control group (P < 0.05, Table IIGo). The percentage reduction in morphine consumption in Group D1 was 53.9% and in Group D2 was 52.9% during the first 24 hr, while VAS scores were similar in all groups up to the first six hours postoperatively. Visual analogue scale scores at 12 hr, 18 hr and 24 hr, during both rest and effort, were lower in Groups D1 and D2 compared to the control group (P < 0.05, Figures 1Go, 2Go, Table IIIGo). The MAP, HR, SpO2, EtCO2 values, airway and intra-abdominal pressures were similar amongst groups (Table IVGo). The frequencies of side effects during the 24 hr observation period were comparable in all three groups. One patient in Group D1 experienced nausea and vomiting; however, no patient in any group experienced itching, headache, respiratory depression or radicular irritation.


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  		TABLE II Intra-and postoperative opioid consumption
 

Figure 1
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  		FIGURE 1 Postoperative visual analogue scale (VAS) scores at rest. Data are mean ± SD, *P < 0.05 different from corresponding value of group 1.

 

Figure 2
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  		FIGURE 2 Postoperative visual analogue scale (VAS) scores during effort. Data are mean ± SD, *P < 0.05 different from corresponding value of group 1.

 

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  		TABLE III VAS scores are rest and during effort and morphine consumption postoperatively at different time intervals
 

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  		TABLE IV Oximetric, hemodynamic and pressure variables
 

   Discussion
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 Abstract
 Introduction
 Methods
 Results
 Discussion
References
 
The major finding of this study is that epidural dexamethasone 5 mg is effective in reducing postoperative pain and systemic opioid requirements following laparoscopic cholecystectomy. The postoperative analgesic efficacy of epidural dexamethasone was not enhanced by a single intraoperative dose of epidural bupivacaine.

The common methods used for analgesia after laparoscopic cholecystectomy produce short-term benefit and do not equate with earlier discharge or improved postoperative function. However, one trial evaluating multimodal analgesia suggested clinically relevant benefits can be achieved.3 Thoracic epidural analgesia with morphine-bupivacaine combination improves analgesia in the first 24 hr following laparoscopic cholecystectomy. 4

Preoperative administration of dexamethasone by oral5,6 and iv7,8 routes has been shown to reduce overall pain scores and analgesic requirements in the postoperative period without any apparent adverse effect. Wang et al.9 showed that epidural administration of dexamethasone reduces the incidence and severity of post-epidural backache following hemorroidectomy, although postoperative pain was not specifically evaluated in that clinical trial.

In a study of 500 hemorroidectomy patients who received epidural dexamethasone 5 mg Wang et al.9 demonstrated no adverse effects over a three-day follow-up period. In contrast Maillefert et al.17 found that a much larger dose of epidural dexamethasone (15 mg) may induce transient adrenal suppression. In an animal model, intrathecal infusion of low dose dexamethasone was shown to be safe, whereas higher doses were associated with inflammation of subarachnoid space.18 Injection of preservative-free medications is often advocated for epidural indications; however, intrathecal injection of methyl-and propyl paraben has been shown to be devoid of neurotoxic effects in both animal and human studies.19,20

As no previous investigation has evaluated the efficacy of epidural dexamethasone for postoperative analgesia, we selected a dose of dexamethasone which has been shown previously to reduce post-epidural backache in patients undergoing hemorroidectomy.9 The timing of drug administration was similar that in a recent study evaluating the postoperative analgesic efficacy of iv dexamethasone in patients undergoing laparoscopic cholecystectomy.8 The selection of laparoscopic cholecystectomy for this study was important to standardize the level of postoperative surgical pain.8 The rationale for using iv dexamethasone 5 mg in a control group was to test whether the action of epidurally administered dexamethasone was at the spinal cord level, or at peripheral tissues after systemic absorption from the epidural space. The reason for using epidural dexamethasone 5 mg alone in Group D2 was to test whether the effect on pain scores in Group D1 was due to prolongation of the action of bupivacaine by dexamethasone.

In the present study, pain scores and total postoperative morphine consumption were lower in patients who received epidural dexamethasone (Groups D1, D2). The results are in keeping with the local application of corticosteroid at the surgical site following lumbar discectomy.21,22 In contrast to the findings from our study, intrathecal administration of corticosteroids in a rat model has been shown to have a mild effect on nociceptor-driven spinal sensitization.14 One possible explanation for this different response to neuraxial steroid administration is that the dose of methylprednisolone and triamicinolone in a rat model was insufficient to prevent the nociceptor-driven spinal sensitization. Blanloeil et al. reported that epidural steroids do not decrease pain after thoracotomy, although in their study the opioid consumption was less in patients who received epidural steroids.23 Possible explanations to account for differences between these studies include sampling size differences and different steroids with different potencies.24

The VAS pain scores in the epidural dexamethasone groups (D1, D2) were lower than observed in the control group in the current investigation. However, differences in the maximum analgesic benefits between groups D1 and D2 after six hours could have mechanistic implications. In a rat model of acute arthritis Ebersberger et al. demonstrated enhanced release of intraspinal prostaglandin E2 after seven to eight hours, with maximum elevation of cyclo-oxygenase-2 protein levels 12 hr after the induction of inflammation.15 These findings are in keeping with reduced central sensitization.

Only one patient in Group D1 in our study experienced nausea and vomiting. The favourably low incidence of nausea and vomiting was probably multi-factorial. Associated factors might have included the dexamethasone-ondansetron combination in the control group,25,26 use of ondansetron within the first six hours,27 and improved analgesia and reduced opioid consumption28 in Groups D1 and D2.

Although this study was not designed to address mechanisms, it is known that epidural dexamethasone may influence intraspinal prostaglandin formation. Acute noxious stimulation of peripheral tissues leads to sensitization of dorsal horn neurons of the spinal cord by the release of excitatory amino acids such as glutamate and aspartate. These amino acids activate Nmethyl- D-aspartate receptors resulting in calcium ion influx. The increased intracellular calcium leads to activation of phospholipase A2, the rate-limiting enzyme in prostaglandin synthesis, which converts membrane phospholipids to arachidonic acid. Simultaneously, there is up-regulation of the expression of cyclo-oxy genase-2 in the spinal cord, leading to prostaglandin E2 synthesis and a resultant hyperalgesic state.14,15 Corticosteroids are capable of reducing prostaglandin synthesis by inhibiting phospholipase A2 through the production of calcium-dependent phospholipid binding proteins called annexins,29 and by the inhibition of cyclo-oxygenase-2 during inflammation.16 The dose of epidural dexamethasone required for the prevention of central sensitization and the time of onset and duration of action is not known.

In conclusion, thoracic epidural dexamethasone 5 mg reduces pain scores and opioid consumption following laparoscopic cholecystectomy, with no apparent side effects. Further investigations are warranted to evaluate the postoperative analgesic efficacy of dexamethasone for other types of surgical procedures.


   Footnotes
 
Competing interests: None declared.

Accepted for publication April 24, 2006. Revision accepted May 11, 2006.


   References
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 Introduction
 Methods
 Results
 Discussion
 References
 
1 Udwadia TE, Patil SU, Udwadia RT, Bhandarkar DS. Laparoscopic cholecystectomy in India. Int Surg 1992; 77: 149–53.[Medline]

2 Bisgaard T, Klarskov B, Kristiansen VB, et al. Multi-regional local anesthetic infiltration during laparoscopic cholecystectomy in patients receiving prophylactic multi-model analgesia: a randomized, double blinded, placebo-controlled study. Anesth Analg 1999; 89: 1017–24.[Abstract/Free Full Text]

3 Wills VL, Hunt DR. Pain after laparoscopic cholecystectomy. Br J Surg 2000; 87: 273–84.[Medline]

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5 Baxendale BR, Vater M, Lavery KM. Dexamethasone reduces pain and swelling following extraction of third molar teeth. Anaesthesia 1993; 48: 961–4.[Medline]

6 Schmelzeisen R, Frolich JC. Prevention of postoperative swelling and pain by dexamethasone after operative removal of impacted third molar teeth. Eur J Clin Pharmacol 1993; 44: 275–7.[Medline]

7 Elhakim M, Ali NM, Rashed I, Riad MK, Refat M. Dexamethasone reduces postoperative vomiting and pain after pediatric tonsillectomy. Can J Anesth 2003; 50: 392–7.[Abstract/Free Full Text]

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9 Wang YL, Tan PP, Yang CH, Tsai SC, Chung HS. Epidural dexamethasone reduces the incidence of backache after lumbar epidural anesthesia. Anesth Analg 1997; 84: 376–8.[Abstract]

10 Price C, Arden N, Coglan L, Rogers P. Cost-effectiveness and safety of epidural steroids in the management of sciatica. Health Technol Assess 2005; 9: 1–74.[Medline]

11 Johansson A, Dahlin L, Kerns JM. Long-term local corticosteroid application does not influence nerve transmission or structure. Acta Anaesthesiol Scand 1995; 39: 364–9.[Medline]

12 Brown FW. Management of diskogenic pain using epidural and intrathecal steroids. Clin Orthop Relat Res 1977; 129: 72–8.[Medline]

13 Sehgal AD, Tweed DC, Gardner WJ, Foote MK. Laboratory studies after intrathecal corticosteroids: determination of corticosteroids in plasma and cerebrospinal fluid. Arch Neurol 1963; 9: 64–8.[Medline]

14 Abram SE, Marsala M, Yaksh TL. Analgesic and neurotoxic effects of intrathecal corticosteroids in rats. Anesthesiology 1994; 81: 1198–205.[Medline]

15 Ebersberger A, Grubb BD, Willingale HL, Gardiner NJ, Nebe J, Schaible HG. The intraspinal release of prostaglandin E2 in a model of acute arthritis is accompanied by an up-regulation of cyclo-oxygenase-2 in the spinal cord. Neuroscience 1999; 93: 775–81.[Medline]

16 Lubenow TR, Ivankovich AD, McCarthy RJ. Management of acute postoperative pain. In: Barash PG, Cullen BF, Stoelting RK (Eds). Clinical Anesthesia, 4th ed. Philadelphia: Lippincott Williams & Wilkins Inc; 2001: 1403–34.

17 Maillefert JF, Aho S, Huguenin MC, et al. Systemic effects of epidural dexamethasone injections. Rev Rhum Eng Ed 1995; 62: 429–32.

18 Kroin JS, Schaefer RB, Penn RD. Chronic intrathecal administration of dexamethasone sodium phosphate: pharmacokinetics and neurotoxicity in an animal model. Neurosurgery 2000; 46: 178–82.[Medline]

19 Eisenach JC, Hood DD, Curry R. Phase I human safety assessment of intrathecal neostigmine containing methyl- and propylparabens. Anesth Analg 1997; 85: 842–6.[Abstract]

20 Gurun MS, Leinbach R, Moore L, Lee CS, Owen MD, Eisenach JC. Studies on the safety of glucose and paraben- containing neostigmine for intrathecal adminstration. Anesth Analg 1997; 85: 317–23.[Abstract]

21 Glasser RS, Knego RS, Delashaw JB, Fessler RG. The perioperative use of corticosteroids and bupivacaine in the management of lumbar disc disease. J Neurosurg 1993; 78: 383–7.[Medline]

22 Mirzai H, Tekin I, Alincak H. Perioperative use of corticosteroid and bupivacaine combination in lumbar disc surgery. A randomized controlled trial. Spine 2002; 27: 343–6.[Medline]

23 Blanloeil Y, Bizouarn P, Le Teurnier Y, et al. Postoperative analgesia by epidural methylprednisolone after posterolateral thoracotomy. Br J Anaesth 2001; 87: 635–8.[Abstract/Free Full Text]

24 Schwartz JJ, Rosenbaum SH, Graf GJ. Anesthesia and the endocrine system. In: Barash PG, Cullen BF, Stoelting RK (Eds). Clinical Anesthesia, 4th ed. Philadelphia: Lippincott Williams & Wilkins Inc; 2001: 1119–39.

25 Lee Y, Lin YS, Chen YH. The effect of dexamethasone upon patient- controlled analgesia- related nausea and vomiting. Anaesthesia 2002; 57: 705–9.[Medline]

26 Rajeeva V, Bhardwaj N, Batra YK, Dhaliwal LK. Comparison of ondansetron with ondansetron and dexamethasone in prevention of PONV in diagnostic laparoscopy. Can J Anesth 1999; 46: 40–4.[Abstract/Free Full Text]

27 Agarwal A, Bose N, Gaur A, Singh U, Gupta MK, Singh D. Acupressure and ondansetron for postoperative nausea and vomiting after laparoscopic cholecystectomy. Can J Anesth 2002; 49: 554–60.[Abstract/Free Full Text]

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29 Yao XL, Cowan MJ, Gladwin MT, Lawrence MM, Angus CW, Shelhamer JH. Dexamethasone alters arachidonate release from human epithelial cells by induction of p11 protein synthesis and inhibition of phospholipase A2 activity. J Biol Chem 1999; 274: 17202–8.[Abstract/Free Full Text]




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