Topical Analgesia with Lidocaine Plus Diclofenac Decreases Pain in Benign Anorectal Surgery: Randomized, Doubleblind, and Controlled Clinical Trial

Abstract

ObjectiveThe aim of this study is to evaluate the efficacy and safety of a topical formulation containing lidocaine plus diclofenac (CLIFE1) compared to lidocaine (CLIFE2), to decrease pain in benign anorectal surgery (BARS) to date not evaluated. More than 50% of patients undergoing BARS, especially hemorrhoidectomy, suffer from moderate and severe postoperative pain. This remains an unresolved problem that could be addressed with the new CLIFE1 topical treatment.MethodsA multicenter, randomized double-blind, active-controlled parallel-group superiority trial, was conducted in two Spanish hospitals. Patients undergoing BARS (hemorrhoids, anal fistula and anal fissure) were randomized at the end of surgery at a 1:1 ratio to receive first dose either CLIFE1 (n = 60) or CLIFE2 (n = 60) anorectal topical treatment, and after every 12 h for the first three postoperative days and once a day from the fourth to sixth. The primary outcome was average of pain decrease after topical treatment, measured with visual analogue scale (VAS) by the patients themselves, the evening in the surgery day and four times daily for the first three postoperative days.ResultsThe results of 120 patients included out of 150 selected undergoing BARS show a decrease in pain after CLIFE1 topical treatment (7.47 ± 13.09) greater than with CLIFE2 (4.38 ± 6.75), difference −3.21 95% CI (−5.75; −0.68), p = 0.008, decreasing significantly postoperative pain ( ≥ 9 mm, VAS) in 35% of patients undergoing benign anorectal surgery, compared to 18.33 % treated with lidocaine.ConclusionsThe CLIFE1 topical treatment shows better analgesic efficacy than CLIFE2 in BARS.

Comparison between intravenous injectable diclofenac and per rectal diclofenac suppository as analgesics in operated per anal and perianal benign pathologies

“…3 Early discharge seemed to be possible in haemorrhoidectomy, later sphincterotomy and submucosal abscess drainage just as seen in the results of Galan and team. [3][4][5][6] It was seen that the most common pathology these people suffered from was haemorrhoids and least was submucosal abscess. [1][2][3][4] The best part was when we scored the average scores in each pathology we noticed that the per anal surgery patients like fissurectomy, incision and drainage of submucosal abscess and haemorrhoids (open and close methods) definitely responded much better to per rectal suppository group B than group A than perianal surgery like perianal abscess drainage and fistula in ano where incisions were on the skin and needed daily dressings.…”

“…[3][4][5][6] It was seen that the most common pathology these people suffered from was haemorrhoids and least was submucosal abscess. [1][2][3][4] The best part was when we scored the average scores in each pathology we noticed that the per anal surgery patients like fissurectomy, incision and drainage of submucosal abscess and haemorrhoids (open and close methods) definitely responded much better to per rectal suppository group B than group A than perianal surgery like perianal abscess drainage and fistula in ano where incisions were on the skin and needed daily dressings. [3][4][5][6] Lateral sphincterotomy and submucosal abscess drainage cases responded excellently and can be even planned discharge on day 2 or 3 with complete pain relief.…”

“…[1][2][3][4] The best part was when we scored the average scores in each pathology we noticed that the per anal surgery patients like fissurectomy, incision and drainage of submucosal abscess and haemorrhoids (open and close methods) definitely responded much better to per rectal suppository group B than group A than perianal surgery like perianal abscess drainage and fistula in ano where incisions were on the skin and needed daily dressings. [3][4][5][6] Lateral sphincterotomy and submucosal abscess drainage cases responded excellently and can be even planned discharge on day 2 or 3 with complete pain relief. [3][4][5][6] Hence now we have started discharging our lateral sphincterotomy and submucosal abscess drainage cases on rectal diclofenac suppositories100 mg twice a day after 24 hours of post op care.…”

“…[3][4][5][6] Lateral sphincterotomy and submucosal abscess drainage cases responded excellently and can be even planned discharge on day 2 or 3 with complete pain relief. [3][4][5][6] Hence now we have started discharging our lateral sphincterotomy and submucosal abscess drainage cases on rectal diclofenac suppositories100 mg twice a day after 24 hours of post op care. Patients have been doing excellent by day 3 and coming for follow-ups with smiling faces.…”

Belgian consensus guideline on the management of hemorrhoidal disease

“…There may be a place for topical treatment of pain after surgery for hemorrhoidal disease. Some agents containing a nitrate donor or a calcium channel blocker may help to relax the internal anal sphincter, reduce congestion of hemorrhoids and alleviate pain intensity (32).…”