Postoperative Analgesia in Major Gynecological Cancer Surgeries

Not Applicable

Not yet recruiting

• Conditions: Analgesia, Epidural; ERAS; Analgesia
• Interventions: Procedure: Patients who underwent epidural block; Procedure: Patients who underwent erector spina plane block

• Registration Number: NCT06424938
• Lead Sponsor: Duygu Akyol

Brief Summary

The aim of this study is to compare the effectiveness of epidural block or erector spinae plane block applied for postoperative analgesia in gynecological cancer surgeries.

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

\[Is erector spinae plane block as effective as epidural block in postoperative analgesia?\] The study was designed as a prospective randomized study. Researchers evaluated the effects of epidural block or erector spinae plane block applied for postoperative analgesia on pain scores, postoperative opioid use, and mobilization in patients undergoing gynecological cancer surgery.

Detailed Description

Our study was designed as a prospective randomized study. The investigators evaluated the analgesia methods used in patients undergoing surgery for gynecologic cancer between May 2024 and December 2024. The investigators evaluated the effect of epidural block or erector spina plan block on postoperative analgesia, opioid use and mobilization.

Group 1: Epidural block group Group 2: Group with erector spina plan block

Study Timeline

• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-17
• Study First Posted: 2024-05-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-29
• Study Start: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Patients who will undergo open abdominal surgery
• Patients with ASAII-III
• Those between the ages of 30-70
• Patients who are fully oriented and able to cooperate

Exclusion Criteria

• Patients with ASAIV-V
• Presence of active infection in the area where the block will be applied
• Patients younger than 30 years old
• Patients with BMI > 40
• Patients who are allergic to bupivacaine
• Chronic analgesic use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The group in which epidural block	Patients who underwent epidural block	The group in which epidural block is applied for postoperative analgesia (Group Epidural)
The group in which erector spinae plane block	Patients who underwent erector spina plane block	The group in which erector spinae plane block is applied (Group ESP)
The group in which epidural block	Patients who underwent erector spina plane block	The group in which epidural block is applied for postoperative analgesia (Group Epidural)
The group in which erector spinae plane block	Patients who underwent epidural block	The group in which erector spinae plane block is applied (Group ESP)

Primary Outcome Measures

Name	Time	Method
postoperative numerical rating scale	postoperatvely 24 hours	The primary purpose of this study is to compare NRS values at 0, 6, 12 and 24 hours in the first 24 hours postoperatively. Numeric rating scale was used to assess postoperative pain For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.

Secondary Outcome Measures

Name	Time	Method
Intraoperative amount of remifentanyl	intraoperative process	The secondary aim of this study is to compare the amount of intraoperative remifentanyl