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Completed
NCT07751770
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
Conditions: Postoperative Pain, Laparoscopic Cholecystectomy
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Saglik Bilimleri Universitesi
Location: Istanbul Provincial Directorate of Health Sultan 2.Abdul Hamid Khan Educational and Research Hospital Istanbul
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07751770). StuddyBuddy aggregates publicly available trial information.