- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07480499
Erector Spinae Plane Versus Quadratus Lumborum Blocks for Pain Management After Total Abdominal Hysterectomy
Comparative Efficacy of Erector Spinae Plane and Quadratus Lumborum Blocks in Managing Postoperative Pain for Total Abdominal Hysterectomy: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients who met the inclusion criteria were recruited in the trial after getting approval from the Hospital Ethical Review Committee and REU CPSP. Demographic information such as age, height, weight, body mass index as well as the functional classification (ASA) was documented on a pre-made proforma. Patients were randomized into two groups using a computer-generated randomisation process.
Group A: Received an ultrasound-guided erector spinae plane block at the T9-T10 level using 20 ml of 0.25% bupivacaine.
Group B: Received an ultrasound-guided posterior quadratus lumborum block using 20 ml of 0.25% bupivacaine.
A qualified anaesthesiologist performed each block in aseptic settings prior to surgery. Standardised general anaesthesia was administered to each patient. The Visual Analogue Scale (VAS) was used to quantify pain at rest and on coughing at 2, 6, 12, 18, and 24 hours. Patents with VAS score more than 4, were given rescue analgesia and the cumulative amount of analgesics used in the first 24 hours as well as the time of the first rescue analgesia were recorded. Patient satisfaction with pain treatment as well as adverse effects such nausea, vomiting, and hypotension were tracked for a duration of 24 hours after the surgery
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hamid Altaf Altaf
- Phone Number: +92 341 4764956
- Email: hamidaltaf331@gmail.com
Study Locations
-
-
Azad Kashmir
-
Muzaffarabad, Azad Kashmir, Pakistan, 13100
- SKBZN CMH Muzaffarabad
-
Contact:
- Bukhari
- Phone Number: 03408133982
- Email: medisolepro@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients aged 35-60 years. ASA physical status I or II. Elective Total Abdominal Hysterectomy under General Anesthesia.
Exclusion Criteria:
Allergy with local anesthetics. Infection in the injection site. Coagulopathy or anticoagulant use. Morbid obesity (BMI > 35 kg/m²).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group B
|
Ultrasound-guided posterior quadratus lumborum block using 20 ml of 0.25% bupivacaine.
|
|
Active Comparator: Group A
|
Ultrasound-guided erector spinae plane block at the T9-T10 level using 20 ml of 0.25% bupivacaine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post Operative Pain
Time Frame: 24 Hours
|
Visual Analogue Score a one-dimensional indicator of pain severity.
It is made up of a horizontal line that is 10 cm (100 mm) long and has two end points marked "No Pain" (0) and "Worst Possible Pain" (10).
On the line, the patient marks the point that most accurately depicts their level of discomfort at 2,4,6,18 & 24 hours post operatively.
|
24 Hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to first Rescue Analgesia
Time Frame: 24 Hourse
|
When a patient's pain score surpasses a certain threshold (e.g., VAS > 4), additional analgesic medication is administered when the primary anaesthetic approach is unable to give sufficient pain relief and the time will be calculated in hours.
|
24 Hourse
|
|
Cumulative Opioid consumption
Time Frame: 24 Hours
|
The total amount of opioid medicine needed by the patient over the course of the first 24 hours following surgery in order to sustain sufficient analgesia.
This is frequently computed as the Morphine Equivalent Dose (mg) and standardised.
|
24 Hours
|
|
Adverse effects
Time Frame: 24 Hours
|
Unwanted and unpleasant effects like nausea, vomiting during 24 hours post operatively
|
24 Hours
|
|
Patient Satisfaction
Time Frame: 24 Hours
|
A conventional 5-point Likert scale that ranges from "Very Dissatisfied" to "Very Satisfied" is usually used to gauge the patient's subjective assessment of the level of pain care they got during 24 hours duration post-operatively
|
24 Hours
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Korgvee A, Junttila E, Koskinen H. Ultrasound-guided quadratus lumborum block for postoperative analgesia: A systematic review of case reports and randomized controlled trials. J Clin Anesth. 2021;71:110214
- Adhikary SD, Pruett A, Forero M, Thiruvenkatarajan V. Erector spinae plane block versusquadratus lumborum block: a meta-analysis of randomized controlled trials. Reg Anesth Pain Med. 2021;46(10):854-863.
- Chavan R, Goklani A, Chavan G, Mali V. Comparison of anterior quadratus lumborum block versus lumbar erector spinae plane block for postoperative analgesia in total abdominal hysterectomy: A randomized controlled study. Pain Med. 2025;26(1):12-18
- Baran O, Şahin A, Arar C. Comparative efficacy of erector spinae plane and quadratus lumborum blocks in managing postoperative pain for total abdominal hysterectomy: A randomized controlled trial. Medicine (Baltimore). 2024;103(43):e40313.
- Abdelaziz TSA, Abdou K, Salem M. Erector spinae plane block versus quadratus lumborum block for postoperative analgesia after abdominal hysterectomy: a randomized comparative study. Anaesth Pain Intensive Care. 2024;28(2):333-340.
- Zewdu D, Tantu T, Eanga S. Analgesic efficacy of erector spinae plane block versus transversus abdominis plane block for laparoscopic cholecystectomy: a systematic review and meta-analysis of randomized controlled trials. Front Med (Lausanne). 2024;11:1399253.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ANS-2023-106-3308
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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