Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Laparoscopy

NCT ID: NCT04506034

Last Updated: 2020-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-09-30

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

lidocaine patches

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

IV lidocaine

Intervention Type: 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.

IV saline infusion

received i.v. saline infusion.

Group Type: PLACEBO_COMPARATOR

IV saline infusion

Intervention Type: DRUG

received i.v. saline infusion.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

IV saline infusion

received i.v. saline infusion.

Intervention Type: DRUG

Other Intervention Names

lidocaine patch; lidocaine infusion; placebo

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hany farouk

A Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

nahla w Shady, md

Role: STUDY_CHAIR

Aswan universirty

Locations

Aswan University Hospital

Aswān, , Egypt

Countries

Egypt

Central Contacts

hany f Sallam, md

Role: CONTACT

hany.farouk@aswu.edu.eg

+20102435461 ext. 002

nahla w Shady, md

Role: CONTACT

hanygyne@yahoo.com

+201022336052 ext. 002

Other Identifiers

aswu/277/7/18

Identifier Type: -

Identifier Source: org_study_id