Dataset Information

Topical Analgesia with Lidocaine Plus Diclofenac Decreases Pain in Benign Anorectal Surgery: Randomized, Double-blind, and Controlled Clinical Trial.

ABSTRACT:

Objective

The 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.

Methods

A 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.

Results

The 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.

Conclusions

The CLIFE1 topical treatment shows better analgesic efficacy than CLIFE2 in BARS.

SUBMITTER: Linares-Gil MJ

PROVIDER: S-EPMC6250696 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Topical Analgesia with Lidocaine Plus Diclofenac Decreases Pain in Benign Anorectal Surgery: Randomized, Double-blind, and Controlled Clinical Trial.

Linares-Gil M J MJ Valls J J Hereu-Boher P P Nebot F J FJ De-Ramón B B Diaz-Munió E E Sanzol R R De-Oca J J Pérez-Lozano P P Suñé-Negre J M JM García-Montoya E E

Clinical and translational gastroenterology 20181123 11

<h4>Objective</h4>The 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.<h4>Methods</h4>A mult ...[more]

PMID: 30467335

Similar Datasets

Project description:BackgroundHemorrhoidectomy is associated with intense postoperative pain that requires multimodal analgesia. It includes nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and local anesthetics to reach adequate pain control. There are data in literature preemptive analgesia could decrease postoperative pain after hemorrhoidectomy. The aim of this study is to assess the efficacy of preemptive analgesia with ketoprofen 100 mg 2 h before procedure per os with spinal anesthesia to decrease postoperative pain according to visual analog scale and to reduce the opioids and other analgesics consumption.MethodsPatients of our clinic who meet the following inclusion criteria are included: hemorrhoids grade III-IV and the planned Milligan-Morgan hemorrhoidectomy. After signing the consent all participants are randomly divided into 2 groups: the first one gets a tablet with 100 mg ketoprofen, the second one gets a tablet containing starch per os 2 h before surgery (72 participants per arm). Patients of both arms receive spinal anesthesia and undergo open hemorrhoidectomy. Following the procedure the primary and secondary outcomes are evaluated: opioid administration intake, the pain at rest and during defecation, duration, and frequency of other analgesics intake, readmission rate, overall quality of life, time from the procedure to returning to work, and the complications rate.DiscussionMultimodality pain management has been shown to improve pain control and decrease opioid intake in patients after hemorrhoidectomy in several studies. Gabapentin can be considered as an alternative approach to pain control as NSAIDs have limitative adverse effects. Systemic admission of ketorolac with local anesthetics also showed significant efficacy in patients undergoing anorectal surgery. We hope to prove the efficacy of multimodal analgesia including preemptive one for patients undergoing excisional hemorrhoidectomy that will help to hold postoperative pain levels no more than 3-4 points on VAS with minimal consumption of opioid analgesics.Trial registrationClinicalTrial.gov NCT04361695 . Registered on April 24, 2020, version 1.0.

Dataset Information

Topical Analgesia with Lidocaine Plus Diclofenac Decreases Pain in Benign Anorectal Surgery: Randomized, Double-blind, and Controlled Clinical Trial.

Objective

Methods

Results

Conclusions

Publications

Topical Analgesia with Lidocaine Plus Diclofenac Decreases Pain in Benign Anorectal Surgery: Randomized, Double-blind, and Controlled Clinical Trial.

Similar Datasets

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