Role of TAP and RS Block in Reduction of Postoperative Pain for Gynecological Surgical Laparoscopic Procedures

May 23, 2018 updated by: Corrado Terranova, Campus Bio-Medico University

The Role of Transversus Abdominis Plane Block and Rectus Sheath Block in Reduction of Postoperative Pain for Gynecological Benign Surgical Laparoscopic Procedures: a Randomized Controlled Trial

The present study aims to demonstrate the effectiveness of loco-regional wall anesthesia of the transversus abdominis plane block (TAP block) and the rectus sheath block (RS block), compared to intravenous analgesia, in terms of pain reduction, postoperative analgesic drugs consumption, patient satisfaction and decrease of LOS (length of stay), in patients undergoing benign gynecological laparoscopic surgical procedures.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

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

  • Italy
    • RM
      • Roma, RM, Italy, 00128

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patients undergoing benign laparoscopic gynecological surgery
  • age between 18 and 75 years
  • BMI >18 e <35
  • ECOG Performance Status 0-1

Exclusion Criteria:

  • age < 18 or > 75 years
  • BMI <18 or > 35
  • ECOG Performance Status >1
  • Allergy to local anesthetics
  • Allergy to NSAIDs
  • Chronic kidney failure > II class
  • Systemic neoplastic disease actual or previous
  • Actual pregnancy
  • Active or recent pelvic inflammation
  • Persistent coagulopathy
  • Previous opioids consumption for chronic pain
  • Neurological or cognitive disorders
  • Conversion from laparoscopic to open surgery
  • Onset of intraoperative complications

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALR
Procedure: TAP block and RS block + General Intravenous Anesthestic
transversus abdominis plane block and rectus sheath block
Active Comparator: EV
Drug: General Intravenous Anesthetic
General Intravenous Anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain in the first 72 hours after gynecological surgical procedures
Time Frame: postoperative pain in the first 72 hours after gynecological surgical procedures
postoperative pain in the first 72 hours after gynecological surgical procedures
postoperative pain in the first 72 hours after gynecological surgical procedures
analgesic consumption in the first 72 hours after gynecological surgical procedures
Time Frame: analgesic consumption in the first 72 hours after gynecological surgical procedures
analgesic consumption in the first 72 hours after gynecological surgical procedures
analgesic consumption in the first 72 hours after gynecological surgical procedures

Collaborators and Investigators

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

Sponsor

Campus Bio-Medico 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 (Actual)

October 12, 2017

Primary Completion (Anticipated)

July 12, 2018

Study Completion (Anticipated)

July 12, 2018

Study Registration Dates

First Submitted

March 9, 2018

First Submitted That Met QC Criteria

May 23, 2018

First Posted (Actual)

May 25, 2018

Study Record Updates

Last Update Posted (Actual)

May 25, 2018

Last Update Submitted That Met QC Criteria

May 23, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIN-TAP 2017

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

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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