Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Laparoscopy

Not Applicable

• Conditions: Infertility
• Interventions: Drug: IV saline infusion; Drug: IV lidocaine; Drug: lidocaine patches

• Registration Number: NCT04506034
• Lead Sponsor: Aswan University Hospital

Brief Summary

To evaluate the efficacy of lidocaine patch applied around wound in laparoscopic gynecologic surgery in reduction of postoperative pain and illus compared to intravenous lidocaine infusion and placebo.

Detailed Description

Postoperative pain after gynecologic surgery is a challenging problem associated with increased morbidity and cost. The inflammatory response to surgery plays a crucial rule in inducing postoperative illus. Systemic local anesthetics proved to have anti-inflammatory properties that may be beneficial in preventing ileus added to its analgesic actions. The lidocaine patch evaluated in many types of pain with promising results. The study try to evaluate the patch in perioperative field as a more simple and safe technique than the intravenous route.

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-07
• Last Update Submitted: 2020-08-07
• Study First Posted: 2020-08-10
• Last Update Posted: 2020-08-10
• Study Start: 2020-09-01
• Primary Completion: 2021-08-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• female undergoing elective gynecologic surgery

Exclusion Criteria

• known allergy to lidocaine,
• respiratory or cardiac dysfunction, arrhythmia, treatment with antiarrhythmic drugs,
• inflammatory bowel disease (Crohn's disease or ulcerative colitis)
• hepatic, renal
• chronic use of analgesics or corticosteroids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV saline infusion	IV saline infusion	received i.v. saline infusion.
IV lidocaine	IV lidocaine	received i.v. lidocaine infusion after induction of anesthesia, 2 mg/min if body weight \>70 kg or 1 mg/min if body weight \<70 kg.
lidocaine patches	lidocaine patches	for every port entry site from the three in ports of laparoscope, patients received three lidocaine patches 5% (Lidoderm® , Endo Pharmaceuticals, Chadds Ford, PA). Each patch measured 10 cm × 14 cm and contains (700 mg), was divided into two equal parts, six parts applied two of it around one port entry site that marked before sterilization and just before induction of anesthesia. The patches not changed until removed after return of bowel function or on the maximum at fifth postoperative day.

Primary Outcome Measures

Name	Time	Method
Pain VAS scores at rest and during coughing were recorded postoperatively	24 hours	To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women at 24 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt