Comparison of Ultrasound-Guided Erector Spinae Plane Block and Modified Thoracoabdominal Nerve Bl… (NCT07751770) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized Controlled Study
Turkey (Türkiye)80 participantsStarted 2025-02-20
Plain-language summary
This study compared two ultrasound-guided regional anesthesia techniques for pain relief after laparoscopic gallbladder surgery: the modified thoracoabdominal nerve block through a perichondrial approach and the erector spinae plane block.
Adults undergoing elective laparoscopic cholecystectomy under general anesthesia were randomly assigned to receive one of these two nerve blocks on both sides of the body before awakening from anesthesia. Both techniques used bupivacaine as the local anesthetic.
After surgery, pain intensity, tramadol consumption, need for additional pain medication, nausea and vomiting, antiemetic use, and block-related complications were assessed during the first 24 postoperative hours. The main objective was to determine whether the two techniques differed in their ability to reduce postoperative tramadol consumption and provide effective pain relief.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 18 and 65 years
* Scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia
* American Society of Anesthesiologists physical status I to III
* Body mass index below 35 kg/m²
* International Normalized Ratio and platelet count within the institutional reference ranges
* Liver and renal function test results within the institutional reference ranges
* Provision of written informed consent
Exclusion Criteria:
* Bleeding diathesis
* Known allergy to local anesthetics
* Infection or inflammation at the planned block application site
* Gallbladder perforation
* Known neurological disease
* American Society of Anesthesiologists physical status IV or higher
* Long-term medication use for chronic pain
* Advanced liver or renal failure
* Previous abdominal surgery or abdominal trauma
* Use of any opioid medication within 24 hours before surgery
* Pregnancy
* Refusal to participate
* Intraoperative conversion from laparoscopic to open surgery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative Postoperative Tramadol Consumption During the First 24 Hours
Timeframe: From arrival in the post-anesthesia care unit through 24 hours after surgery