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

Not Applicable

Completed

• Conditions: Postoperative Pain; Analgesia; Postoperative Complications; Regional Anesthesia Morbidity
• Interventions: Procedure: Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block; Procedure: Patients undergoing rectus sheat block and posterior transversus abdominis plane block

• Registration Number: NCT06342076
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01
• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-04-02
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group1: Subcostal transversus abdominis plane block(STAPB)	Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block	Subcostal transversus abdominis plane block(STAPB)
Group 2: Rectus sheat block(RSB)	Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block	Rectus sheat block(RSB)
Group1: Subcostal transversus abdominis plane block(STAPB)	Patients undergoing rectus sheat block and posterior transversus abdominis plane block	Subcostal transversus abdominis plane block(STAPB)
Group 2: Rectus sheat block(RSB)	Patients undergoing rectus sheat block and posterior transversus abdominis plane block	Rectus sheat block(RSB)

Primary Outcome Measures

Name	Time	Method
visuel analog scale	24 hours postoperatively	Our primer aim was to compare postoperative pain scores. The first 24 hours postoperatively were evaluated.Numeric Rating Scale(NRS) was used to assess postoperative pain.6th, 12th, 24th hour NRS values were recorded For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.

Secondary Outcome Measures

Name	Time	Method
amount of opioid used	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.

Trial Locations

Locations (1)

Başakşehir Çam and Sakura City Hospital; 🇹🇷 Istanbul, Basaksehir, Turkey