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NCT Number: NCT06424938

Postoperative Analgesia in Major Gynecological Cancer Surgeries

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.

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Key information

Conditions

Analgesia Agnosia Analgesia, Epidural ERAS Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Basaksehir Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patients who underwent epidural block

Procedure

The researchers administered an epidural block to prevent post-operative pain to the epidural block group undergoing midline incision surgery for major gynecologic cancer.

Patients who underwent erector spina plane block

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Intraoperative amount of remifentanyl

    Time frame: intraoperative process

    The secondary aim of this study is to compare the amount of intraoperative remifentanyl

Other outcomes

  1. postoperative mobilization time

    Time frame: postoperatvely 24 hours

    The other purpose of this study is the first postoperative mobilization process

Sponsors and collaborators

Lead sponsor

Duygu Akyol

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 22, 2024
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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