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* From the Department of Anaesthesia and Intensive Care, Makassed General Hospital;
the Faculty of Public Health, Lebanese University, Beirut, Lebanon; and
the Department of Anesthesia and Intensive Care, KS/Astrid Lindgren Children’s Hospital, Stockholm, Sweden.
Address correspondence to: Dr. Zouheir Naja, Department of Anesthesia and Intensive Care, Makassed General Hospital, B.O. Box: 11-6301 Riad El-Solh 11072210, Beirut, Lebanon. Phone: 961-1-655-466; Fax: 961-1-646-589; E-mail: zouhnaja{at}yahoo.com
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Abstract |
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Methods: Following Ethical Committee approval and informed consent 90 patients scheduled for hemorrhoidectomy were randomized to three different groups of 30 patients each: general anesthesia alone, general anesthesia plus nerve stimulator guided pudendal nerve block or general anesthesia plus placebo nerve blocks. Postoperative pain, the primary outcome variable of the study, was assessed by visual analogue scale scores at predetermined time intervals during the postoperative period. Total amount of analgesics, time to return to normal activities and patient satisfaction were also recorded.
Results: The pudendal nerve block group was found to have better postoperative pain-relief (P < 0.005), reduced need for analgesics (P < 0.05), and also a more rapid return to normal activities (P < 0.001) compared to general anesthesia alone or in combination with placebo blocks. The pudendal nerve block group was also associated with significantly higher patient satisfaction (P < 0.001) compared to the other two groups.
Conclusion: A combination of general anesthesia and nerve stimulator guided pudendal nerve block showed significantly reduced postoperative pain, shortened hospital stay, and earlier return to normal activity. Thus, this technique deserves more widespread use in patients undergoing hemorrhoidectomy.
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Introduction |
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A modification of the pudendal nerve block (PNB) technique has been used at our institution since 1999 in order to reduce postoperative pain following hemorrhoidectomy. Initial results have pointed to significantly reduced postoperative pain, shortened hospital stay and earlier return to work and normal activity. The aim of the current study was to corroborate our previous observational data by conducting a prospective double-blind placebo-controlled randomized trial. The primary outcome variables were postoperative pain assessed by visual analogue scale (VAS) scores at predetermined time intervals during the postoperative period, time to return to normal activities and postoperative analgesics’ consumption.
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Methods |
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Patients with chronic renal failure, coagulopathy, symptoms of bladder neck obstruction, or patients for whom it would not be possible to conduct a telephone follow-up were not eligible for study inclusion. The study was conducted and funded at the Makassed General Hospital between June 1, 2002, and May 31, 2003.
Type of surgical procedure
All patients underwent open radical hemorrhoidectomy.15 Skin flaps were raised next to the squamocutaneous junction and advanced up to the dentate line (origin of the plexus). Excision of the plexus was then performed and the rectal mucosa was sutured to the fibres of the internal sphincter muscle.
Protocol for GA
All patients were given iv preoperative sedation before induction of anesthesia (midazolam 0.15 mg•kg–1). GA was induced by iv fentanyl (1.5 µg•kg–1) and thiopental (3–5 mg•kg–1) followed by endotracheal intubation facilitated by atracurium (0.5 mg•kg–1). Anesthesia was subsequently maintained with isoflurane 1 to 3%, nitrous oxide 70% and oxygen 30%. The isoflurane concentration was adjusted with the intention of keeping heart rate and blood pressure within ± 25% of preinduction values.
PNB technique
PNB or placebo injections were performed with the patient in the lithotomy position. Four separate injection points were used as indicated in Figure 1
. Thus, patients in the GA group received only GA whereas patients assigned to the PL or PNB groups received a pudendal injection of either normal saline or a local anesthetic mixture (containing a mixture of bupivacaine, lidocaine, fentanyl and clonidine), respectively (total volume of injection 0.7 mL•kg–1). Following aseptic preparation of the skin each of the four injection sites was infiltrated with 1 mL of 1% lidocaine. At the posterior injection points at four and eight o’clock (Figure 1) a 22-gauge 10-cm nerve stimulator needle (Stimuplex, B.Braun, Melsungen, Germany) was subsequently advanced approximately 7 to 10 cm (depending on patient size) perpendicularly to the skin in all planes, using a stimulating current of 2.5 to 5.0 mA and 1 Hz (Stimuplex, B.Braun, Melsungen, Germany). When appropriate nerve stimulation of the pudendal nerve with its inferior rectal nerve and perineal branches could be verified (visualized as ipsilateral contractions of the posterior parts of the anal sphincter) the needle-tip position was optimized in a normal fashion by preserving muscle contractions while reducing the stimulating current to 0.5–0.6 mA, and the injection was performed.
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0.2 mL•kg–1 were injected at each of the posterior injection points (four and eight o’clock) and 0.15 mL•kg–1 were injected at each of the anterior injection points (two and ten o’clock; total volume of injection: 0.7 mL•kg–1). The time needed to perform the pudendal block ranged between ten to 20 min.
Each 20 mL of the local anesthetic mixture contained: 6 mL lidocaine 2%, 6 mL lidocaine 2% with adrenaline 5 µg•mL–1, 5 mL bupivacaine 0.5%, 1 mL fentanyl 50 µg•mL–1 and 2 mL clonidine 75 µg•mL–1. This mixture has previously been reported to provide long-lasting postoperative pain relief after peripheral nerve blocks performed for various types of surgical interventions.16–19
To allow for adequate blinding the solution used for injection (saline or local anesthetic mixture) was prepared by an independent nurse outside the operating room and the randomization code was not broken before the end of the study. Patients, data collection nurses, surgeons, and anesthesiologists were thus all kept unaware of the nature of the injected solution.
Data collection
Demographic data, duration of surgery and recovery room stay, postoperative nausea and vomiting (PONV), urinary retention, patient satisfaction and duration of hospital stay were recorded. Postoperative pain was assessed at rest at predetermined time intervals during the first six postoperative days (six hour, 12 hr, 24 hr, 36 hr, 48 hr, three days, four days, five days, and six days; Figure 2) using a VAS (0 - no pain and 100 - worst possible pain) and was also recorded at the first postoperative defecation. Amount of opioids consumed was recorded for the first six postoperative days. Following hospital discharge the patients were instructed to note the following: number of postoperative days required until the patient was able to sit and walk without pain and also the time (days) until return to work (employed patients) or normal activity (unemployed patients); these patient data were all collected at a 30-day follow-up telephone call.
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Pharmacological management of postoperative pain
Patients with a VAS > 40 during the stay in hospital were given im pethidine (l mg•kg–1) as supplemental analgesia, whereas patients with VAS score < 40 were given an oral combination of dextropropoxifen (30 mg) and paracetamol (400 mg; Diantalvic, HoechstMarion-Roussel, France). Following discharge, patients were prescribed 20 mL of lactulose (Duphalac, Solvay Pharmaceuticals B.V., NL-Weesp, The Netherlands) twice daily and oral diclonefac 50 mg (Voltaren, Licence Novartis Pharma AG, Basle, Switzerland) three times daily for three weeks. Patients were also prescribed an oral dextropropoxifen - paracetamol combination if they needed additional analgesia following hospital discharge.
Statistics
The assessment of postoperative pain by VAS was used as the primary end-point of the study. Secondary endpoints were consumption of analgesics, duration of hospital stay and time to return to work/normal activities.
Based on our previous observational data 30 patients in each group were found to be necessary in order to detect a 30% difference in VAS scores at six hours between the three groups with a confidence level of 95% (
= 0.05) and a power of 90% (ß = 0.10).
ANOVA tests with repeated measures were performed to determine significant differences for mean values between the study groups regarding age, height, weight, duration of operation, length of hospital stay and VAS scores. Chi-square tests were used for testing the differences in sex, PONV and need for supplemental opioid administration. P values less than 0.05 were considered significant.
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Results |
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). The incidences of PONV and urinary retention were also found to be similar between groups (Table II).
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). The vast majority of GA and PL patients needed supplemental iv or oral analgesics during the first six postoperative days (Figure 3) and the opioid consumption in the GA and PL groups was significantly higher compared to the PNB group (P < 0.05). VAS score associated with the first postoperative defecation was also significantly lower in the PNB group compared to the other two study groups (Table II
).
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). Five patients from the GA group and two patients from the PL group experienced severe exacerbation of pain on postoperative day four or five, necessitating readmission to the emergency room for adequate pain control.
The vast majority of PNB patients (97%) left the hospital within 24 hr which was significantly earlier than GA and PL patients (P < 0.05; Table II).
PNB patients were back to work or normal activity significantly sooner in comparison to GA and PL patients (P < 0.01). On average, PNB patients (seven days) were back to work or normal activity one week before GA patients (14 days) and PL patients (14 days; Table II).
Patient satisfaction with the anesthetic technique and postoperative pain relief was significantly higher in the PNB group (90%) compared to the GA group (37%) and the PL group (33%; P < 0.0001; Table II).
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Discussion |
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Postoperative pain following hemorrhoidectomy is usually very intense20 and the pain at the first postoperative defecation has been described "like passing bits of broken glass."21 Severe postoperative pain usually leads to prolonged convalescence associated with substantial analgesic consumption, which in turn results in a typical sick-leave period of two to three weeks.4 Attempts to improve the situation by using new surgical techniques have unfortunately not been entirely successful5,7 and the results from using different types of topical application or infiltration of local anesthetics have been equally disappointing.8–13 Excellent surgical anesthesia and also good initial postoperative analgesia can be accomplished by the use of caudal or spinal anesthesia but the postoperative analgesia is short-lived and is also associated with disturbing side-effects e.g., urinary retention.12,13 Finding a method that can reduce postoperative pain substantially and, thus, would allow a more rapid recovery would be of great importance both for the patient and society in general.
The results of the present study corroborate our previous pilot observations of superior pain-relief, decreased consumption of analgesics, shorter hospital stay and a reduced period of sick-leave following an anesthetic regimen consisting of GA combined with a PNB using a mixture of local anesthetics, fentanyl and clonidine (Appendix, available as Additional Material at www.cja-jca.org). Our current data are also in keeping with the findings of Luck et al. who, in a small prospective randomized clinical trial, found the combination of GA and ischiorectal fossa block with plain local anesthetics to produce improved analgesia during the first 24 hr following hemorrhoidectomy compared to GA alone.22
In addition to the apparent cost savings for the health care system by a reduced duration of hospital stay and the obvious advantages both for the employer and the employee from a shorter sick-leave period, maybe the most interesting finding of the study was the extended period of pain-relief associated with our PNB technique.
The high success rate seen obtained in the present study is most likely due to the use of a nerve-stimulator guided technique that will improve the accuracy of needle placement and hence the chance of an adequate nerve block. However, the use of such a nerve-stimulator guided technique cannot explain the extended period of postoperative analgesia that significantly outlasted the expected duration (five to six hours) of the local anesthetic component of the mixture used for the block. This is in keeping with our previously published experience with this particular anesthetic mixture that has been associated with surprisingly long duration of analgesia following different types of surgery.16–19 Administration of clonidine23 and opioids24,25 with local anesthetic solutions has been found capable of prolonging the duration of peripheral nerve blocks, but the observed period of analgesia following the use of the current mixture of local anesthetics, fentanyl and clonidine outlasts an additive or even a synergistic effect of the drugs used and, instead, infers a preemptive analgesic action.26
Although preemptive analgesia has been validated in various experimental pain models, very few studies have been able to substantiate this concept in the clinical setting.16 A recent study by Giannoni and coworkers in pediatric tonsillectomy patients, showing improved postoperative analgesia for five days following pre-incision infiltration of the tonsillar fossae with a mixture of local anesthetic and clonidine,26 corroborates our results. Recent case reports and experimental studies by Lavand’homme and Eisenach have also been able to show prolonged periods of pain-relief following administration of local anesthetic-clonidine solutions close to injured nerves.27 Based on their own results and also previous studies by other research groups they speculate that clonidine is causing this effect by an interaction with the immune system, resulting in reduced recruitment of macrophages and lymphocytes at the nerve injury site and shift of the proportion of macrophages from the pro- to the anti-inflammatory phenotype.27 Since hemorrhoidectomy will inevitably injure a large number of nerve endings and minor nerves at the site of surgery, such a theory could, potentially, explain the very long-lasting effects associated with our local anesthetic mixture.
In summary, in the present prospective, randomized controlled clinical trial the combination of GA and a PNB, using a mixture of local anesthetics, fentanyl and clonidine, was found to substantially reduce postoperative pain, consumption of analgesics, pain at first defecation and shorten the time to return to normal activities and work compared to GA alone or in combination with a PL. The use of a PNB was also associated with a very high overall patient satisfaction. Thus, the positive results of the present study appear to merit more widespread use of guided PNB in hemorrhoidectomy patients.
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Footnotes |
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References |
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2 Low AW. Pain in haemorrhoid repair. Nurs Times 1975; 71: 930–1.[Medline]
3 Erichsen CJ, Vibits H, Dahl JB, Kehlet H. Wound infiltration with ropivacaine and bupivacaine for pain after inguinal herniotomy. Acta Anaesthesiol Scand 1995; 39: 67–70.[Medline]
4 Carapeti EA, Kamm MA, McDonald PJ, Phillips RK. Double-blind randomised controlled trial of effect of metronidazole on pain after day-case haemorrhoidectomy. Lancet 1998; 351: 169–72.[Medline]
5 Rowsell M, Bello M, Hemingway DM. Circumferential mucosectomy (stapled haemorrhoidectomy) versus conventional haemorrhoidectomy: randomised controlled trial. Lancet 2000; 355: 779–81.[Medline]
6 Milligan ET, Morgan CN, Jones LE, Officer R. Surgical anatomy of the anal canal, and operative treatment of haemorrhoids. Lancet 1937; 1119–24.
7 Cheetham MJ, Mortensen NJ, Nystrom PO, Kamm MA, Phillips RK. Persistent pain and faecal urgency after stapled haemorrhoidectomy. Lancet 2000; 356: 730–3.[Medline]
8 Hussein MK, Taha AM, Haddad FF, Bassim YR. Bupivacaine local injection in anorectal surgery. Int Surg 1998; 83: 56–7.[Medline]
9 Vinson-Bonnet B, Coltat JC, Fingerhut A, Bonnet F. Local infiltration with ropivacaine improves immediate postoperative pain control after hemorrhoidal surgery. Dis Colon Rectum 2002; 45: 104–8.[Medline]
10 Ho KS, Eu KW, Heah SM, Seow-Choen F, Chan YW. Randomized clinical trial of haemorrhoidectomy under a mixture of local anaesthesia versus general anaesthesia. Br J Surg 2000; 87: 410–3.[Medline]
11 Read TE, Henry SE, Hovis RM, et al. Prospective evaluation of anesthetic technique for anorectal surgery. Dis Colon Rectum 2002; 45: 1553–60.[Medline]
12 Petros JG, Bradley TM. Factors influencing postoperative urinary retention in patients undergoing surgery for benign anorectal disease. Am J Surg 1990; 159: 374–6.[Medline]
13 Pybus DA, D’Bras BE, Goulding G, Liberman H, Torda TA. Postoperative analgesia for haemorrhoid surgery. Anaesth Intensive Care 1983; 11: 27–30.[Medline]
14 Zuidema GD. Shackelford’s Surgery of The Alimentary Tract, volume 4, 4th ed. Philadelphia: W.B. Saunders Company; 1996: 330–1.
15 Mehigan BJ, Monson JR, Hartley JE. Stapling procedure for haemorrhoids versus Milligan-Morgan haemorrhoidectomy: randomised controlled trial. Lancet 2000; 355: 782–5.[Medline]
16 Naja Z, el Hassan MJ, Khatib H, Ziade MF, Lönnqvist PA. Combined sciatic-paravertebral nerve block vs. general anaesthesia for fractured hip of the elderly: reduced need for postoperative intensive care monitoring. Middle East J Anesthesiol 2000; 15: 559–68.[Medline]
17 Naja MZ, el Hassan M, Oweidat M, Zbibo R, Ziade MF, Lönnqvist PA. Paravertebral blockade vs general anesthesia or spinal anesthesia for inguinal hernia repair. Middle East J Anesthesiol 2001; 16: 201–10.[Medline]
18 Naja Z, Ziade MF, Lönnqvist PA. Bilateral paravertebral somatic nerve block for ventral hernia repair. Eur J Anaesthesiol 2002; 19: 197–202.[Medline]
19 Naja Z, Lönnqvist PA. Somatic paravertebral nerve blockade. Incidence of failed block and complications. Anaesthesia 2001; 56: 1184–8.[Medline]
20 Beattie GC, Wilson RG, Loudon MA. The contemporary management of haemorrhoids. Colorectal Dis 2002; 4: 450–4.[Medline]
21 Goligher J. Surgery of the Anus, Rectum and Colon, 5th ed. London: BailliereTindall; 1984: 98–149.
22 Luck AJ, Hewett PJ. Ischiorectal fossa block decreases posthemorrhoidectomy pain. Randomized, prospective, double-blind clinical trial. Dis Colon Rectum 2000; 43: 142–5.[Medline]
23 Singelyn FJ, Gouverneur JM, Robert A. A minimum dose of clonidine added to mepivacaine prolongs the duration of anesthesia and analgesia after axillary brachial plexus block. Anesth Analg 1996; 83: 1046–50.[Abstract]
24 Sanchez R, Nielsen H, Heslet L, Iversen AD. Neuronal blockade with morphine. A hypothesis. Anaesthesia 1984; 39: 788–9.[Medline]
25 Mays KS, Lipman JJ, Schnapp M. Local analgesia without anesthesia using peripheral perineural morphine injections. Anesth Analg 1987; 66: 417–20.
26 Giannoni C, White S, Enneking FK, Morey T. Ropivacaine with or without clonidine improves pediatric tonsillectomy pain. Arch Otolaryngol Head Neck Surg 2001; 127: 1265–70.
27 Lavand’homme PM, Eisenach JC. Perioperative administration of the 2-adrenoceptor agonist clonidine at the site of nerve injury reduces the development of mechanical hypersensitivity and modulates local cytokine expression. Pain 2003; 105: 247–54.[Medline]
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