Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Laparoscopy

NCT04506034 | Unknown DMC

• 1 other identifier: aswu/277/7/18
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Pain VAS scores at rest and during coughing were recorded postoperatively

  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".

  24 hours

Study Arms (3)

lidocaine patches

EXPERIMENTAL

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.

Drug: lidocaine patches

IV lidocaine

ACTIVE COMPARATOR

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.

Drug: IV lidocaine

IV saline infusion

PLACEBO COMPARATOR

received i.v. saline infusion.

Drug: IV saline infusion

Interventions

lidocaine patches DRUG

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.

Also known as: lidocaine patch

lidocaine patches

IV lidocaine DRUG

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.

Also known as: lidocaine infusion

IV lidocaine

IV saline infusion DRUG

received i.v. saline infusion.

Also known as: placebo

IV saline infusion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: female for laparoscopic gynecology
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female undergoing elective gynecologic surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Infertility

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• nahla w Shady, md

  Aswan universirty

  STUDY CHAIR

Central Study Contacts

hany f Sallam, md

CONTACT

+20102435461; hany.farouk@aswu.edu.eg

nahla w Shady, md

CONTACT

+201022336052; hanygyne@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: randomized controlled trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A Professor

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 10, 2020
• Study Start: September 1, 2020
• Primary Completion: August 30, 2021
• Study Completion: September 30, 2021
• Last Updated: August 10, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)