Postoperative Analgesia in Major Gynecological Cancer Surgeries

May 17, 2024 updated by: Duygu Akyol

The Effect of Epidural Analgesia and Erector Spinae Plane Block on Intraoperative and Early Postoperative Outcomes in Open Gynecological Oncological Surgeries: a Prospective Randomized Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

70

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 Contact

Study Contact Backup

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:

  • 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 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The group in which epidural block
The group in which epidural block is applied for postoperative analgesia (Group Epidural)
Procedure: Patients who underwent epidural block
The researchers administered an epidural block to prevent post-operative pain to the epidural block group undergoing midline incision surgery for major gynecologic cancer.
Procedure: Patients who underwent erector spina plane block
Researchers applied a erector spina plane block to prevent postoperative pain to the erector spina plane block group undergoing midline incision surgery for major gynecological cancer.
Experimental: The group in which erector spinae plane block
The group in which erector spinae plane block is applied (Group ESP)
Procedure: Patients who underwent epidural block
The researchers administered an epidural block to prevent post-operative pain to the epidural block group undergoing midline incision surgery for major gynecologic cancer.
Procedure: Patients who underwent erector spina plane block
Researchers applied a erector spina plane block to prevent postoperative pain to the erector spina plane block group undergoing midline incision surgery for major gynecological cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative numerical rating scale
Time Frame: 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.
postoperatvely 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative amount of remifentanyl
Time Frame: intraoperative process
The secondary aim of this study is to compare the amount of intraoperative remifentanyl
intraoperative process

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative mobilization time
Time Frame: postoperatvely 24 hours
The other purpose of this study is the first postoperative mobilization process
postoperatvely 24 hours

Collaborators and Investigators

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

Sponsor

Duygu Akyol

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 (Estimated)

May 13, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 17, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-597

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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