Postoperative Analgesia in Major Gynecological Cancer Surgeries

NCT ID: NCT06424938

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-01-31

Brief Summary

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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

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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

Conditions

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Analgesia Analgesia, Epidural ERAS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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The group in which epidural block

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

Group Type EXPERIMENTAL

Patients who underwent epidural block

Intervention Type 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

Intervention Type 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 erector spinae plane block

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

Group Type EXPERIMENTAL

Patients who underwent epidural block

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Duygu Akyol

OTHER_GOV

Sponsor Role lead

Responsible Party

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Duygu Akyol

M.D

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Basaksehir Cam and Sakura City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 37086524 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33388155 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25449564 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19783285 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19395071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31635757 (View on PubMed)

Other Identifiers

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2023-597

Identifier Type: -

Identifier Source: org_study_id

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