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CompletedNCT06424938Updated Sep 22, 2025

Postoperative Analgesia in Major Gynecological Cancer Surgeries

An interventional study of Patients who underwent epidural block and Patients who underwent erector spina plane block in Analgesia, Analgesia, Epidural and ERAS, sponsored by Duygu Akyol. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by Duygu Akyol · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
71
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
Female
01

Study 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.

Read the 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

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Conditions studied

  • Analgesia
  • Analgesia, Epidural
  • ERAS

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Keywords

  • postoperative analgesia
  • periferic nerve block
  • neuraxial block
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In context

Agnosia

1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.

This study's enrollment of 71 is close to the median of 78 across 1,024 interventional studies indexed under Agnosia.

Browse Agnosia studies →

Lead sponsor

Duygu Akyol is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
71 participants (actual)

Study arms

  • 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 · Procedure: Patients who underwent erector spina plane block

  • 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 · Procedure: Patients who underwent erector spina plane block

Interventions

  • ProcedurePatients 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.

  • ProcedurePatients 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.

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What researchers measure

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.

    Time frame: postoperatvely 24 hours

Secondary outcomes

  1. Intraoperative amount of remifentanyl

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

    Time frame: intraoperative process

Other outcomes

  1. postoperative mobilization time

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

    Time frame: postoperatvely 24 hours

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Study locations

1 site
  • Basaksehir Cam and Sakura City Hospital
    Istanbul, Turkey (Türkiye)
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References and documents

Publications

  • 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. PubMed 37086524 ↗
  • 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. PubMed 33388155 ↗
  • 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. PubMed 25449564 ↗
  • 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. PubMed 19783285 ↗
  • 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. PubMed 19395071 ↗
  • 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. PubMed 31635757 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06424938
Lead sponsor
Duygu Akyol
Responsible party
Duygu Akyol (M.D, Bakirkoy Dr. Sadi Konuk Research and Training Hospital) — Sponsor-investigator
First posted
May 22, 2024
Start date
Jul 1, 2024
Primary completion
Jan 1, 2025
Completion
Jan 31, 2025
Last update
Sep 22, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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