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

Primary Purpose

Postoperative Complications

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Bupivacaine

About this trial

This is an interventional supportive care trial for Postoperative Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

Wolfson medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Sub cutaneous+Intraperitoneal

Sub cutaneous+Placebo

Placebo+Intraperitoneal

Placebo+Placebo

Arm Description

Sub cutaneous Bupivacaine+ Intraperitoneal bupivacaine

Sub cutaneous Bupivacaine+ Intraperitoneal Nacl 0.9%

Sub cutaneous Nacl 0.9%+ Intraperitoneal bupivacaine

Sub cutaneous Nacl 0.9%+ Intraperitoneal Nacl 0.9%

Outcomes

Primary Outcome Measures

Pain level during movement, 8 hours after laparoscopy

Secondary Outcome Measures

Full Information

NCT ID

NCT02976571

First Posted

November 23, 2016

Last Updated

May 8, 2018

Sponsor

Wolfson Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02976571

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (Actual)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wolfson Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Complications

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sub cutaneous+Intraperitoneal

Arm Type

Experimental

Arm Description

Sub cutaneous Bupivacaine+ Intraperitoneal bupivacaine

Arm Title

Sub cutaneous+Placebo

Arm Type

Active Comparator

Arm Description

Sub cutaneous Bupivacaine+ Intraperitoneal Nacl 0.9%

Arm Title

Placebo+Intraperitoneal

Arm Type

Active Comparator

Arm Description

Sub cutaneous Nacl 0.9%+ Intraperitoneal bupivacaine

Arm Title

Placebo+Placebo

Arm Type

Placebo Comparator

Arm Description

Sub cutaneous Nacl 0.9%+ Intraperitoneal Nacl 0.9%

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Other Intervention Name(s)

Marcaine

Intervention Description

Sub cutaneous and/or Intraperitoneal Marcaine application

Primary Outcome Measure Information:

Title

Pain level during movement, 8 hours after laparoscopy

Time Frame

8 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ohad Gluck, MD

Phone

97235028329

ohadgluck@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Elad Barer, MD

Phone

9725028329

elad.barber@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ohad Gluck, MD

Organizational Affiliation

Wolfson Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wolfson medical center

City

H̱olon

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ohad Gluck, MD

Phone

97235028329

ohadgluck@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33420214

Citation

Gluck O, Barber E, Feldstein O, Tal O, Kerner R, Keidar R, Wolfson I, Ginath S, Bar J, Sagiv R. The effect of subcutaneous and intraperitoneal anesthesia on post laparoscopic pain: a randomized controlled trial. Sci Rep. 2021 Jan 8;11(1):81. doi: 10.1038/s41598-020-80130-6.

Results Reference

derived

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

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