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Trial Title:
Postoperative Analgesia in Major Gynecological Cancer Surgeries
NCT ID:
NCT06424938
Condition:
Analgesia
Analgesia, Epidural
ERAS
Conditions: Official terms:
Agnosia
Conditions: Keywords:
postoperative analgesia
periferic nerve block
neuraxial block
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
Patients who underwent epidural block
Description:
The researchers administered an epidural block to prevent post-operative pain to the
epidural block group undergoing midline incision surgery for major gynecologic cancer.
Arm group label:
The group in which epidural block
Arm group label:
The group in which erector spinae plane block
Intervention type:
Procedure
Intervention name:
Patients who underwent erector spina plane block
Description:
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.
Arm group label:
The group in which epidural block
Arm group label:
The group in which erector spinae plane block
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
Criteria for 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 > 40
- Patients who are allergic to bupivacaine
- Chronic analgesic use
Gender:
Female
Minimum age:
30 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
July 1, 2024
Completion date:
January 31, 2025
Lead sponsor:
Agency:
Duygu Akyol
Agency class:
Other
Source:
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06424938