THE EFFECT OF COMBINATION OF DICLOFENAC SUPPOSITORY AND LIGNOCAINE CREAM ON POSTOPERATIVE PAIN AFTER ANAL SURGERY

THE EFFECT OF COMBINATION OF DICLOFENAC SUPPOSITORY AND LIGNOCAINE CREAM ON POSTOPERATIVE PAIN AFTER ANAL SURGERY

By

Mohammad Arafat Abdel-Maksoud

General Surgery Department, Faculty of Medicine, Al-Azhar University

ABSTRACT

Background: Anal surgery is associated with severe postoperative pain which is a source of such anxiety that some patients refuse the operation. Opiates and non-steroidal anti-inflammatory drugs have often been used to control pain.

Objectives: Evaluation of the effect of diclofenac suppository and lignocaine cream on postoperative pain after anal surgery.

Paitents and Methods: This study was a prospective randomized double blinded controlled study carried on 120 patients presenting with anal conditions (hemorrhoid, anal fissure or low perianal fistula), who underwent anal surgery. Patients were divided randomly into two equal groups. Group (A) was a control group, and group (B) received diclofenac suppository (100 mg) and topical lignocaine cream 5% (5 g) at the end of surgery. The mean VAS scores at 2, 4, 8, 12, and 24 hours after surgery were recorded.

Results: The pain reported by group (B) was statistically lower than that in control group (group A) in all intervals. Also, the incidence for administration of postoperative analgesic in group (B) was statistically lower than that in group (A).

Conclusion: Combination of diclofenac suppository and topical lignocaine cream significantly decreased the severity of postoperative pain after anal surgery, and decreased the requirement of post-operative analgesics.

Key words: Anal surgery, topical lignocaine, diclofenac suppository.

INTRODUCTION

     Commonly surgical anal conditions are hemorrhoids, anal fissure and perianal fistula. These conditions almost need surgical interference. Surgery is associated with severe postoperative pain which is a source of such anxiety that some patients refuse the operation. Opiates and non-steroidal anti-inflammatory drugs (NSAIDs) have often been used to control pain (Ala et al., 2013).

     Opiates have important adverse effects including drowsiness, apnea, nausea, vomiting, respiratory depression, and ileus. NSAIDs are safer than opiates with the same effect on postoperative pain (Lohsiriwat, 2012).

     Postoperative pain and delayed wound healing are the most annoying problems to the patients and the surgeons, pain may be explained by surgical wound in the sensitive perianal skin and anoderm and the edema from inflammation around the wound (Nienhuijs & de Hingh, 2010 and Uzzaman & Siddiqui, 2011). Various topical applications were used to reduce pain e.g. calcium channel blockers, local anesthetics, botulinum toxin, glyceryl trinitrate (GTN), metronidazole, opioids, sucralfate, one herbal cream mainly consist of Aloe vera (Watson et al., 2016). Consequently, the introduction of novel methods for the control of pain after anal surgery is required.

     Local anesthetics considered as an important components of multimodal analgesic regimens for surgical wound and proved efficacy and tolerability when administered appropriately (Golembiewski and Dasta, 2015). Dicofenac sodium is a NSAID and has an analgesic and antipyretic effect.

     The aim of our study was to evaluate the effect of diclofenac suppository and lignocaine cream on postoperative pain after anal surgery.

PATIENTS AND METHODS

     This study was a prospective randomized double blinded controlled study performed at the department of surgery, Al-Azhar university hospitals. It was carried on one hundred and twenty patients (69 males and 51 females) with the mean age 38.7±3.8 (range 17–67) years, presenting with anal conditions (hemorrhoid, anal fissure or low perianal fistula), who underwent anal surgery (hemorrhoidectomy, fissurectomy, or fistulotomy).

Inclusion criteria: Patients 17 years or older, have 3rd or 4th degree hemorrhoids, or those have chronic anal fissure or low perianal fistula.

Exclusion criteria: Patients with previous anal surgery, poorly controlled diabetes mellitus, severe anemia, hypoalbuminemia and liver or renal impairment.

     All anal surgery (hemorrhoidectomy, fissurectomy, or fistulotomy) performed under spinal anesthesia. At the end of surgery, patients were divided randomly into two groups (A, B), 60 patients each group. Group (A) was a control group, and group (B) received diclofenac suppository (100 mg) and topical lignocaine cream 5% (5 gm) at the end of surgery.

     All patients were admitted to surgical department of Al-Azhar University hospital and referred from outpatient clinics in the period between September 2015 and February 2018. The study was approved by the local ethics committee of surgery department. Informed consent was granted from all patients. All patients in our study underwent history taking, complete clinical examination and investigations.

     Assessment of pain was based on a visual analogue scale (VAS) ranging from 0 (no pain) to 10 (severest pain); 2, 4, 8, 12 and 24 hours after operation. Patients were given (Nalbuphine 4mg) intravenously if their VAS score was ≥ 7. Pain scores, total nalbuphine consumption, patient’s requests for administration of postoperative analgesics were recorded.

Statistical analysis:

     Data were summarized by mean ± standard deviation and categorical variables are expressed as percentage (%). Univariate analyses were performed by Chi square, unpaired student’s t-test. Results were considered significant if P values were less than 0.05.

RESULTS

     The patient’s characteristics including age, sex, types of anal surgery were recorded in the two groups (Table 1). There were no significant differences between the two groups as regard baseline characteristics.

Table (1): Base line patient’s characteristics

     Post-operatively: The mean VAS score at 2, 4, 8, 12, and 24 hours after surgery was recorded, it has been shown that the pain reported by group B (diclofenac suppository and lignocaine cream) was statistically lower than that in control group (group A) in all intervals (Table 2).

Table (2): Pain scores on a visual analogue scale (VAS) at different time points after surgery (mean ± SD)

     After 4 hours post-operatively, 11 patients (18.3%) of group B and 32 patients (53.3%) of group A required analgesic. Furthermore, 25 patients (41.6%) of group B and all patients (100%) of group A required analgesic at 8 hour post-operatively. After 12 hours, 35 patients (58.3%) of group B and 48 patients (80%) of group A required analgesics. After 24 hours, the requirement of analgesics decreased in both groups, but still more significant in group A (Table 3). The incidence for administration of postoperative analgesic in group B was statistically lower than that in group A (P-value < 0.005). Also, the mean nalbuphine consumption dose in group B (6.3 ± 3.5 mg) was statistically lower than that in group A (16 ± 6.8 mg) with P-value < 0.001 (Table 3).

Table (3): Incidence of post-operative analgesic dose requirement and consumption

DISCUSSION

     The severity of postoperative pain after anal surgery is a major problem. Multiple factors may be a cause of pain as patient’s tolerance, type of anesthesia, type of post-operative analgesia, surgical technique and edema and tissue inflammation around the surgical wound all lead to more worsening of post-operative pain (Gupta et al., 2008). It may delay discharge from hospital, recovery and return to work. Various invasive and noninvasive trails have been made to reduce pain after anal surgery (Shiau et al., 2008).

     Noninvasive methods suggested to control post-hemorrhoidectomy pain, including application of topical preparations such as botulinum toxin, nitrates (Watson et al., 2016), and metronidazole do not seem to offer any benefit in terms of rapid pain relief in the first 24 hours after open hemorrhoidectomy (Uzzaman and Siddiqui, 2011).

     It has been shown that NSAIDs like diclofenac reduce postoperative pain by blocking cyclo-oxigenase (COX) enzyme and can be used as anesthetic drugs (Arab et al., 2013).

     Topical lignocaine cream (local anesthetic) and diclofenac suppository drugs had been investigated in this study to reduce the severity of postoperative pain.

     Results of current study showed that; the pain reported by group B (diclofenac suppository and lignocaine cream) was statistically lower than that in control group (group A) in all intervals. Also, the incidence for administration of postoperative analgesic in group B was statistically lower than that in group A. Also, the mean nalbuphine consumption dose in group B was statistically lower than that in group A.

     In a study by (Shiau et al., 2008), local anesthetic cream, EMLA cream (lidocaine 2.5% and prilocaine 2.5%) was used for post hemorrhoidectomy pain and showed a better pain control and patient satisfaction than control group.

     (Rahimi et al., 2012), in their study to evaluate the effect of EMLA cream and diclofenac suppository on post-operative pain, reported that EMLA showed better short-term pain control following hemorrhoidectomy, while more sustainable pain control was provided by diclofenac suppository.

     (Alkhateep and Fareed, 2017), in their study on 150 patients, observed that pain intensity was significantly lower in local anesthetic cream group than placebo group at the 1st, 3rd and 7th days after anal surgery.

CONCLUSION

     Combination of diclofenac suppository and topical lignocaine cream is significantly lower the severity of postoperative pain after anal surgery and decrease the requirement of post-operative analgesics. Also increase the patient satisfaction.

REFERENCES

1. Ala S, Saeedi M, Eshghi F, Rafati M, Hejazi V and Hadianamrei R (2013): Efficacy of 10% sucralfate ointment in the reduction of acute postoperative pain after open hemorrhoidectomy: a prospective, double-blind, randomized, placebo controlled trial. World J Surg., 37(1): 233-8.

2. Alkhateep Y and Fareed A (2017): Double blinded randomized placebo controlled comparative study between sucralfate ointment and lidocaine ointment after Milligan Morgan hemorrhoidectomy. Int Surg J., 4(12): 3822-3826.

3. Arab M, Motahhar HS, Pazouki A, Tamannaie Z, Arabpour B and Fahimi H (2013): Efficacy of diclofenac rectal suppository in patients with laparoscopic cholecystectomy: A prospective randomized double blinded clinical trial.  J Minim Invasive Surg Sci., 2(4):43-5.

4. Golembiewski J and Dasta J (2015): Evolving Role of Local Anesthetics in Managing Postsurgical Analgesia. Clinical Therapeutics, 37(6):1354-71.

5. Gupta P, Heda PS, Kalaskar S, Tamaskar VP (2008): Topical sucralfate decreases pain after hemorrhoidectomy and improves healing: A randomized, blinded, controlled study. Dis Colon Rectum, 51: 231-4.

6. Lohsiriwat V (2012): Hemorrhoids: from basic pathophysiology to clinical management. World J. Gastroenterol., 18:2009-17.

7. Nienhuijs SW and de Hingh I (2010): Pain after conventional versus Ligasure haemorrhoidectomy. A meta-analysis. Int J Surg., 8: 269-273.

8.  Rahimi M, Kazemeini AR, Pourtabatabaei N and Honarmand AR (2012): Comparison of topical anesthetic cream (EMLA) and diclofenac suppository for pain relief after hemorrhoidectomy: a randomized clinical trial. Surg Today, 42(12):1201-5.

9. Shiau JM, Su HP, Chen HS, Hung KC, Lin SE and Tseng CC (2008): Use of a topical anesthetic cream (EMLA) to reduce pain after hemorrhoidectomy. Reg Anesth Pain Med., 33: 30-5.

10. Uzzaman MM and Siddiqui MRS (2011): A brief literature review on the management of post-haemorrhoidectomy pain. Surgical Techniques Development, 1(2): 32-9.

11. Watson AJM, Hudson J, Wood J, Kilonzo M, Brown SR and McDonald A (2016): Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial. Lancet, 388:2375-85.