Effect of Different Volumes of Erector Spinae Plane Block on Postoperative Opioid Consumption After Total Abdominal Hysterectomy
Comparison of the Effectiveness of Erector Spinae Plane Block Administered at Different Volumes on Postoperative Opioid Consumption and Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized, Prospective, Double-Blind Study
1 other identifier
interventional
80
1 country
1
Brief Summary
his study aims to investigate the effects of different volumes of ultrasound-guided erector spinae plane block (ESPB) on postoperative pain and opioid consumption in patients undergoing total abdominal hysterectomy. The researchers aim to determine whether varying the volume of local anesthetic in the ESPB can reduce the amount of morphine required by patients and improve pain scores during the first 24 hours after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable postoperative-pain
Started Jan 2022
Shorter than P25 for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedFirst Submitted
Initial submission to the registry
April 10, 2026
CompletedFirst Posted
Study publicly available on registry
April 16, 2026
CompletedApril 16, 2026
April 1, 2026
5 months
April 10, 2026
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Total Morphine Consumption
The total amount of morphine (in milligrams) consumed by the patient via the Patient-Controlled Analgesia (PCA) device.
First 24 hours postoperatively
Secondary Outcomes (2)
Numerical Rating Scale (NRS) Scores for Pain
At postoperative 30 minutes, 2nd, 6th, 12th, and 24th hours
Number of Blocked Dermatomes
20 minutes after the block procedure
Study Arms (2)
Group I
ACTIVE COMPARATORPatients in Group I received a preoperative bilateral ultrasound-guided erector spinae plane block (ESPB) with 20 ml of 0.25% bupivacaine hydrochloride (prepared by combining 10 ml of 0.5% bupivacaine hydrochloride with 10 ml of saline) for each side.
Group II
ACTIVE COMPARATORPatients in Group I received a preoperative bilateral ultrasound-guided erector spinae plane block (ESPB) with 30 ml of 0.25% bupivacaine hydrochloride (prepared by combining 15 ml of 0.5% bupivacaine hydrochloride with 15 ml of saline) for each side.
Interventions
The ESPB will be performed at the T8-T9 vertebral levels. The T7 vertebra, aligned with the inferior angles of the scapulae, will be identified, and the T8 vertebra will be located one level below via palpation. Patients will be placed in the prone position, and skin preparation will be performed with 10% povidone-iodine. Local anesthesia of the skin and subcutaneous tissue will be provided with 3 ml of 2% lidocaine at the target injection site. Under ultrasound guidance, a sterile-covered linear probe (8 MHz) will be used to visualize the T8 spinous process in the horizontal plane at the midline. The probe will then be rotated to the longitudinal plane, approximately 3 cm lateral to the midline, to visualize the transverse process and the overlying erector spinae muscle. A 22-gauge, 80-mm block needle will be advanced in-plane in a cranio-caudal direction until it contacts the transverse process. After confirming the position between the erector spinae muscle and the transverse proces
Eligibility Criteria
You may qualify if:
- Patients aged between 18 and 65 years.
- Patients with American Society of Anesthesiologists (ASA) physical status I-III.
- Patients scheduled to undergo elective total abdominal hysterectomy surgery.
You may not qualify if:
- Obese patients (Body Mass Index \> 30 kg/m²).
- Patients with local skin infection at the site of needle insertion.
- Patients with a known allergy to any of the medications used in the study.
- Patients with coagulopathy.
- Patients with chronic opioid consumption.
- Patients with an inability to use the Patient-Controlled Analgesia (PCA) device.
- Patients with advanced hepatic or renal failure.
- Patients who refuse to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Şule Arıcanlead
Study Sites (1)
Necmettin Erbakan University Faculty of Medicine
Konya, 42040, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Şule Arıcan, Assoc. Prof.
Necmettin Erbakan University Faculty of Medicine, Department of Anesthesiology and Reanimation
- PRINCIPAL INVESTIGATOR
Hasan Çekdemir, specialist
Hadim State Hospital, Department of Anesthesiology and Reanimation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 10, 2026
First Posted
April 16, 2026
Study Start
January 1, 2022
Primary Completion
June 1, 2022
Study Completion
June 1, 2022
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share