- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07479069
Erector Spinae Plane Block for Pain Control After Open Abdominal Surgery
March 13, 2026 updated by: Fatima Majeed, Fatima Memorial Hospital
Effect of Bilateral Erector Spinae Plane Block on Postoperative Opioid Consumption in Open Abdominal Surgeries Under General Anaesthesia
his randomized controlled trial aims to evaluate the efficacy of the bilateral erector spinae plane (ESP) block in reducing postoperative opioid consumption in patients undergoing open abdominal surgeries under general anesthesia
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Patients undergoing abdominal surgeries experience severe postoperative pain.
Conventional pain management methods, including opiates, may pose significant side effects.
This study addresses the imperative need for optimizing postoperative pain management by systematically investigating the analgesic effects and complications associated with the bilateral ESP block.
The study involves 46 patients allocated into two groups using a lottery method: a control group receiving standard pain control treatment, and an erector spinae block group receiving a bilateral ESP block in addition to standard pain control treatment.
Pain intensity will be evaluated using a visual analogue scale (VAS) at 4, 8, 12, and 24 hours after the operation.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Department of Anesthesia, Fatima Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- American Society of Anesthesiology (ASA) stage I-II.
- Scheduled for abdominal surgery due to any indication.
Exclusion Criteria:
- History of Diabetes
- History of neuropathic diseases
- History of gastrointestinal bleeding, peptic ulcer, or inflammatory bowel disease
- History of long-term nonsteroidal anti-inflammatory
- History of chronic opioid analgesic use
- History of severe hepatic or renal failure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
Patients receiving standard pain control treatment.
Postoperatively, patients receive 1000 mg of IV paracetamol every 6 hours.
If a patient reports a Visual Analogue Score (VAS) exceeding five, they will receive rescue analgesia consisting of nalbuphine 4mg
|
Patients receive 1000 mg of IV paracetamol every 6 hours postoperatively.
If a patient experiences a Visual Analogue Score (VAS) of more than five at any time, they receive rescue analgesia in the form of nalbuphine 4mg
|
|
Experimental: Erector Spinae Block Group
Patients receiving bilateral ESP block in addition to standard pain control treatment
|
Patients receive 1000 mg of IV paracetamol every 6 hours postoperatively.
If a patient experiences a Visual Analogue Score (VAS) of more than five at any time, they receive rescue analgesia in the form of nalbuphine 4mg
Administered after the induction of general anesthesia and before the surgical incision.
Local anesthetic (0.25% ropivacaine or 0.25% bupivacaine) will be injected for a total of 20-40 mL
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Opioid Consumption
Time Frame: Within the first 24 hours after surgery
|
Assessed by the percentage of patients requiring rescue opioid analgesia.
The need for rescue analgesia is determined by a Visual Analogue Score (VAS) greater than five
|
Within the first 24 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2025
Primary Completion (Estimated)
March 31, 2026
Study Completion (Estimated)
March 31, 2026
Study Registration Dates
First Submitted
March 13, 2026
First Submitted That Met QC Criteria
March 13, 2026
First Posted (Actual)
March 18, 2026
Study Record Updates
Last Update Posted (Actual)
March 18, 2026
Last Update Submitted That Met QC Criteria
March 13, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Behavioral Disciplines and Activities
- Digestive System and Oral Physiological Phenomena
- Behavioral Sciences
- Dentistry
- Dental Physiological Phenomena
- Dental Occlusion
- Parapsychology
Other Study ID Numbers
- FMH-15/12/2025-IRB-1840
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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