Local and Intraperitoneal Analgetics in Gynecologic Laparoscopy for Post Operative Pain Relief

Not Applicable

• Conditions: Postoperative Complications
• Interventions: Drug: Bupivacaine

• Registration Number: NCT02976571
• Lead Sponsor: Wolfson Medical Center

Brief Summary

A comparison between local and intraperitoneal analgetics to placebo, during laparoscopy, regarding post operative pain.

Detailed Description

4 randomly assigned groups. Grop 1 will get sub cutaneous and intraperitoneal marcain. Grop 2 will get sub cutaneous marcaine and intraperitoneal saline. Grop 3 will get sub cutaneus saline and intraperitoneal marcaine. Grop 4 will get ub cutaneous and intraperitoneal saline

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-11-29
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-08
• Last Update Posted: 2018-05-09
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Elective laparoscopy

Exclusion Criteria

• Laparotomy Vaginal operations Oncologic operations Chronic use of analgetics due to pelvic pain Pregnancy Operations lasts more than 3 hours

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sub cutaneous+Intraperitoneal	Bupivacaine	Sub cutaneous Bupivacaine+ Intraperitoneal bupivacaine
Sub cutaneous+Placebo	Bupivacaine	Sub cutaneous Bupivacaine+ Intraperitoneal Nacl 0.9%
Placebo+Intraperitoneal	Bupivacaine	Sub cutaneous Nacl 0.9%+ Intraperitoneal bupivacaine
Placebo+Placebo	Bupivacaine	Sub cutaneous Nacl 0.9%+ Intraperitoneal Nacl 0.9%

Primary Outcome Measures

Name	Time	Method
Pain level during movement, 8 hours after laparoscopy	8 hours

Trial Locations

Locations (1)

Wolfson medical center; 🇮🇱 H̱olon, Israel