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

May 8, 2018 updated by: Wolfson Medical Center
A comparison between local and intraperitoneal analgetics to placebo, during laparoscopy, regarding post operative pain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • H̱olon, Israel
        • Recruiting
        • Wolfson Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sub cutaneous+Intraperitoneal
Sub cutaneous Bupivacaine+ Intraperitoneal bupivacaine
Drug: Bupivacaine
Sub cutaneous and/or Intraperitoneal Marcaine application
Other Names:
  • Marcaine
Active Comparator: Sub cutaneous+Placebo
Sub cutaneous Bupivacaine+ Intraperitoneal Nacl 0.9%
Drug: Bupivacaine
Sub cutaneous and/or Intraperitoneal Marcaine application
Other Names:
  • Marcaine
Active Comparator: Placebo+Intraperitoneal
Sub cutaneous Nacl 0.9%+ Intraperitoneal bupivacaine
Drug: Bupivacaine
Sub cutaneous and/or Intraperitoneal Marcaine application
Other Names:
  • Marcaine
Placebo Comparator: Placebo+Placebo
Sub cutaneous Nacl 0.9%+ Intraperitoneal Nacl 0.9%
Drug: Bupivacaine
Sub cutaneous and/or Intraperitoneal Marcaine application
Other Names:
  • Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain level during movement, 8 hours after laparoscopy
Time Frame: 8 hours
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Investigators

  • Principal Investigator: Ohad Gluck, MD, Wolfson Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

November 28, 2016

First Posted (Estimate)

November 29, 2016

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 8, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0198-16-WOMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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