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Completed
NCT07552701
USG-Guided TAPA vs RIFB Block for Postoperative Analgesia in Laparoscopic Cholecystectomy
Conditions: Postoperative Pain, Acute Cholecystitis, Cholelithiasis, Postoperative Nausea and Vomiting
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 81
Sponsor: Hitit University
Location: Hitit University Çorum
Summary
Laparoscopic cholecystectomy (LC) can cause moderate-to-severe postoperative pain from visceral, referred shoulder, and incisional sources. Multimodal analgesia is recommended, but opioids carry significant side effects. Ultrasound-guided interfascial plane blocks offer a safe alternative. The Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) blocks T5-T12 dermatomes, while the Recto-Intercostal Fascial Plane Block (RIFPB) provides sensory blockade across the upper anterolateral abdomen. This study compares the postoperative analgesic efficacy of bilateral M-TAPA versus bilateral RIFPB in patients undergoing LC.
Eligibility Criteria
Inclusion Criteria:
* Age 18-65 years
* ASA physical classification I-II
* BMI \< 35 kg/m²
* Scheduled for elective laparoscopic cholecystectomy due to cholelithiasis
* Able to use and understand the NRS pain scoring system
* Able to use and understand the QoR-15 scale
* Able to communicate in Turkish
* Provided written informed consent
Exclusion Criteria:
* Refusal to participate in the study
* BMI ≥ 35 kg/m²
* ASA physical classification III-V
* Age \< 18 or \> 65 years
* Allergy to local anesthetics or study analgesics
* Pregnancy or breastfeeding
* Inability to use or understand the NRS pain scoring system or QoR-15 scale
* Inability to communicate in Turkish
* Uncontrolled anxiety disorder
* Alcohol or drug dependency
* Neuromuscular or peripheral nerve disease
* High-dose opioid use within 3 days prior to surgery
* Widespread chronic pain
* Diabetes mellitus
* Hepatic or renal insufficiency
* Coagulation disorders or anticoagulant use
* Infection at the block needle insertion site
* Concurrent second surgical procedure alongside laparoscopic cholecystectomy
* Previous abdominal surgery or trauma history
* Conversion from laparoscopic to open surgery
* Technical problems with the PCA device
* NRS score \> 7 for four consecutive hours despite multimodal analgesia
* Planned postoperative non-extubation
* Termination of surgery before completion for any reason
Source: ClinicalTrials.gov (NCT07552701). StuddyBuddy aggregates publicly available trial information.