Clinical trial NCT06424938: Postoperative Analgesia in Major Gynecological Cancer Surgeries
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Analgesia
Analgesia, Epidural
ERAS
Keywords: postoperative analgesia
periferic nerve block
neuraxial block
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2024-05-22
Enrollment: 70
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.

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

Eligibility criteria: 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 \&gt; 40
* Patients who are allergic to bupivacaine
* Chronic analgesic use

Primary outcomes:
measure: postoperative numerical rating scale
timeFrame: postoperatvely 24 hours
Secondary outcomes:
measure: Intraoperative amount of remifentanyl
timeFrame: intraoperative process
Other outcomes:
measure: postoperative mobilization time
timeFrame: postoperatvely 24 hours
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.