Postoperative Analgesia in Major Gynecological Cancer Surgeries

NCT06424938 | Completed

• 1 other identifier: 2023-597
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Analgesia, Epidural; ERAS

Keywords

postoperative analgesia; periferic nerve block; neuraxial block

Outcome Measures

Primary Outcomes (1)

• postoperative numerical rating scale

  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 Outcomes (1)

• Intraoperative amount of remifentanyl

  intraoperative process

Other Outcomes (1)

• postoperative mobilization time

  postoperatvely 24 hours

Study Arms (2)

The group in which epidural block

EXPERIMENTAL

The group in which epidural block is applied for postoperative analgesia (Group Epidural)

Procedure: Patients who underwent epidural block; Procedure: Patients who underwent erector spina plane block

The group in which erector spinae plane block

EXPERIMENTAL

The group in which erector spinae plane block is applied (Group ESP)

Procedure: Patients who underwent epidural block; Procedure: Patients who underwent erector spina plane block

Interventions

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.

The group in which epidural block; The group in which erector spinae plane block

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.

The group in which epidural block; The group in which erector spinae plane block

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duygu Akyol: lead

Study Sites (1)

Basaksehir Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

• Nelson G, Fotopoulou C, Taylor J, Glaser G, Bakkum-Gamez J, Meyer LA, Stone R, Mena G, Elias KM, Altman AD, Bisch SP, Ramirez PT, Dowdy SC. Enhanced recovery after surgery (ERAS(R)) society guidelines for gynecologic oncology: Addressing implementation challenges - 2023 update. Gynecol Oncol. 2023 Jun;173:58-67. doi: 10.1016/j.ygyno.2023.04.009. Epub 2023 Apr 21.

  PMID: 37086524 BACKGROUND

• Bisch SP, Jago CA, Kalogera E, Ganshorn H, Meyer LA, Ramirez PT, Dowdy SC, Nelson G. Outcomes of enhanced recovery after surgery (ERAS) in gynecologic oncology - A systematic review and meta-analysis. Gynecol Oncol. 2021 Apr;161(1):46-55. doi: 10.1016/j.ygyno.2020.12.035. Epub 2020 Dec 30.

  PMID: 33388155 BACKGROUND

• Courtney-Brooks M, Tanner Kurtz KC, Pelkofski EB, Nakayama J, Duska LR. Continuous epidural infusion anesthesia and analgesia in gynecologic oncology patients: less pain, more gain? Gynecol Oncol. 2015 Jan;136(1):77-81. doi: 10.1016/j.ygyno.2014.10.015. Epub 2014 Oct 23.

  PMID: 25449564 BACKGROUND

• Chen LM, Weinberg VK, Chen C, Powell CB, Chen LL, Chan JK, Burkhardt DH 3rd. Perioperative outcomes comparing patient controlled epidural versus intravenous analgesia in gynecologic oncology surgery. Gynecol Oncol. 2009 Dec;115(3):357-61. doi: 10.1016/j.ygyno.2009.08.015. Epub 2009 Sep 23.

  PMID: 19783285 BACKGROUND

• Ferguson SE, Malhotra T, Seshan VE, Levine DA, Sonoda Y, Chi DS, Barakat RR, Abu-Rustum NR. A prospective randomized trial comparing patient-controlled epidural analgesia to patient-controlled intravenous analgesia on postoperative pain control and recovery after major open gynecologic cancer surgery. Gynecol Oncol. 2009 Jul;114(1):111-6. doi: 10.1016/j.ygyno.2009.03.014. Epub 2009 Apr 23.

  PMID: 19395071 BACKGROUND

• Lin C, Gill R, Kumar K. [Bilateral lower thoracic erector spinae plane block in open abdominal gynecologic oncology surgery: a cases series]. Braz J Anesthesiol. 2019 Sep-Oct;69(5):517-520. doi: 10.1016/j.bjan.2019.03.011. Epub 2019 Oct 19.

  PMID: 31635757 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D

Model Details: This study was designed as a prospective randomized study. Patients with ASA II-III between the ages of 30 and 70 who will undergo major gynecological cancer surgery will be included in the study. They will be randomized into 2 groups: the group in which epidural block is applied for postoperative analgesia (Group Epidural) and the group in which erector spinae plane block is applied (Group ESP).

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 22, 2024
• Study Start: July 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 31, 2025
• Last Updated: September 22, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)