Laparoscopic Guided Transversus Abdominis Plane Block Versus Trocar Site Infiltration in Gynecologic Laparoscopy.

September 3, 2018 updated by: IBRAHIM ABD ELGAFOR, Zagazig University

Laparoscopic Guided Transversus Abdominis Plane Block Versus Trocar Site Local Anesthetic Infiltration in Gynecologic Laparoscopy.

to compare between Laparoscopic Guided Transversus Abdominis Plane Block and Trocar Site Infiltration as postoperative analgesia in Gynecologic Laparoscopic surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

two groups of patients who are eligible for Gynecologic Laparoscopy were randomized to either Laparoscopic Guided Transversus Abdominis Plane Block or Trocar Site Infiltration at the end of the operation.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

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

  • Egypt
      • Zagazig, Egypt
        • Zagazig University

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 to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patients Need Gynecologic Laparoscopy

Exclusion Criteria:

  • diagnosed with chronic pain syndrome
  • have a postoperative intraperitoneal drain
  • necessitating alteration to laparotomy.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Laparoscopic
Laparoscopic Guided Transversus Abdominis Plane Block using Bupivacaine
Drug: Laparoscopic Guided Bupivacaine
Bupivacaine Laparoscopic GuidedTransversus Abdominis Plane Block
Other Names:
  • marcaine
ACTIVE_COMPARATOR: local
Trocar Site Infiltration of Bupivacaine
Drug: local Bupivacaine
Bupivacaine Trocar Site Infiltration
Other Names:
  • marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain Scores
Time Frame: 24 Hours
24 Hours

Collaborators and Investigators

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

Sponsor

Zagazig University

Investigators

  • Principal Investigator: ibrahim A el sharkwy, MD, Zagazig University

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

April 1, 2016

Primary Completion (ACTUAL)

July 1, 2017

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

November 22, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (ESTIMATE)

November 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 3, 2018

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3

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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