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

W

Wolfson Medical Center (WMC)

Status

Unknown

Conditions

Postoperative Complications

Treatments

Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02976571
0198-16-WOMC

Details and patient eligibility

About

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

Full 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

Enrollment

120 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

120 participants in 4 patient groups, including a placebo group

Sub cutaneous+Intraperitoneal
Experimental group
Description:
Sub cutaneous Bupivacaine+ Intraperitoneal bupivacaine
Treatment:
Drug: Bupivacaine
Sub cutaneous+Placebo
Active Comparator group
Description:
Sub cutaneous Bupivacaine+ Intraperitoneal Nacl 0.9%
Treatment:
Drug: Bupivacaine
Placebo+Intraperitoneal
Active Comparator group
Description:
Sub cutaneous Nacl 0.9%+ Intraperitoneal bupivacaine
Treatment:
Drug: Bupivacaine
Placebo+Placebo
Placebo Comparator group
Description:
Sub cutaneous Nacl 0.9%+ Intraperitoneal Nacl 0.9%
Treatment:
Drug: Bupivacaine

Trial contacts and locations

1

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Central trial contact

Ohad Gluck, MD; Elad Barer, MD

Data sourced from clinicaltrials.gov

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