Comparison of the Efficacy of Peripheral Nerve Blocks in Major Open Gynaecological Cancer Surgery

March 28, 2024 updated by: Duygu Akyol, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Comparison of the Efficacy of Subcostal Transversus Abdominis Plane Block and Rectus Sheath Block for Postoperative Analgesia in Major Open Gynaecological Cancer Surgery: a Prospective Randomised Study

The aim of this prospective randomized study was to compare the effectiveness of subcostal transversus abdominis plane block or rectus sheath block applied in addition to posterior transversus abdominis plane block for postoperative analgesia in major gynecological cancer surgeries.

The main question(s) it aims to answer are:

[Is subcostal transversus abdominis plane block more effective in postoperative analgesia? ] [Is there a difference in pain scores at 24 hours after surgery? ] Since pain scores within the first 24 hours after surgery will be evaluated, participants will be asked to give a value between 0 and 10 at certain time periods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective, randomized study was conducted at Başakşehir Çam and Sakura City Hospital in accordance with the Declaration of Helsinki. After ethics committee approval (decision no: 2023-596, date: 22.11.2023) and written consent from all patients, the study was conducted according to Consolidated Standards of Reporting Trials (CONSORT) guidelines. In the study, which included a total of 50 patients, the patients were divided into two groups: subcostal transversus abdominis plane block (STAPB) or rectus sheath block (RSB). Postoperative 24-hour VAS values, opioid demand and administration amounts in intravenous patient-controlled analgesia, presence of nausea and vomiting, surgical complications and length of hospital stay were evaluated (6th hour, 12th hour, 24th hour).

Study Type

Interventional

Enrollment (Actual)

50

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

  • Turkey
    • Basaksehir
      • Istanbul, Basaksehir, Turkey
        • Başakşehir Çam and Sakura City Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • >18 years
  • ASA II-III

Exclusion Criteria:

  • Those who are allergic to local anesthetics
  • BMI> 40 kg/m2
  • Those with chronic pain
  • Those with a history of previous abdominal surgery
  • Patients who refuse the use of postoperative patient-controlled analgesia

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group1: Subcostal transversus abdominis plane block(STAPB)
Subcostal transversus abdominis plane block(STAPB)
Procedure: Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block
To prevent postoperative pain, the researchers applied a subcostal transversus abdominis plane block in addition to the posterior transversus abdominis plane block to a group of patients who underwent surgery with a midline incision due to major gynecological cancer.
Procedure: Patients undergoing rectus sheat block and posterior transversus abdominis plane block
To prevent postoperative pain, the researchers applied a rectus sheath block in addition to the posterior transversus abdominis plane block to a group of patients who were operated on through a midline incision due to major gynecological cancer.
Experimental: Group 2: Rectus sheat block(RSB)
Rectus sheat block(RSB)
Procedure: Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block
To prevent postoperative pain, the researchers applied a subcostal transversus abdominis plane block in addition to the posterior transversus abdominis plane block to a group of patients who underwent surgery with a midline incision due to major gynecological cancer.
Procedure: Patients undergoing rectus sheat block and posterior transversus abdominis plane block
To prevent postoperative pain, the researchers applied a rectus sheath block in addition to the posterior transversus abdominis plane block to a group of patients who were operated on through a midline incision due to major gynecological cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visuel analog scale
Time Frame: 24 hours postoperatively
Our primer aim was to compare postoperative pain scores. The first 24 hours postoperatively were evaluated.Visual analog scale(VAS) was used to assess postoperative pain.6th, 12th, 24th hour VAS values were recorded For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of opioid used
Time Frame: 24 hours postoperatively
Our secondary aim was to evaluate the opioid amount (mg) in the first 24 hours of intravenously administered opioids with patient-controlled analgesia.
24 hours postoperatively

Collaborators and Investigators

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

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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)

January 1, 2024

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-596

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.

Clinical Trials on Postoperative Complications

Clinical Trials on Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe