Comparing two ultrasound-guided abdominal nerve blocks to reduce pain after laparoscopic gallbladder removal
Comparison of Ultrasonography-Guided the Postoperative Analgesic Efficacy of Perichondrial Approach Modified Thoracoabdominal Nerve Block and Recto-Intercostal Fascial Plan Block in Patients Who Underwent Laparoscopic Cholecystectomy
This trial will test whether two different ultrasound-guided abdominal nerve blocks (M-TAPA or RIFPB) reduce pain, opioid use, and nausea after laparoscopic gallbladder surgery in adults aged 18–65.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hitit University Academic / other |
| Locations | 1 site (Çorum) |
| Trial ID | NCT07552701 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for elective laparoscopic cholecystectomy will receive either bilateral Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) or bilateral Recto-Intercostal Fascial Plane Block (RIFPB) performed under ultrasound guidance. Pain scores, opioid consumption, and postoperative nausea and vomiting will be recorded using standard scales such as the NRS and QoR-15. Patients meet inclusion criteria of age 18–65, ASA I–II, BMI <35, can communicate in Turkish, and provide informed consent. Outcomes will compare postoperative analgesic efficacy and side-effect profiles between the two block techniques.
Who should consider this trial
Good fit: Adults 18–65 years old with cholelithiasis scheduled for elective laparoscopic cholecystectomy, ASA I–II, BMI under 35, who can communicate in Turkish and give written consent are ideal candidates.
Not a fit: Patients with BMI over 35, ASA III–V, diabetes, significant hepatic or renal disease, pregnancy or breastfeeding, high-dose recent opioid use, coagulation disorders, chronic widespread pain, or inability to communicate in Turkish are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, one of the blocks could provide better pain relief with lower opioid requirements and fewer side effects after laparoscopic gallbladder removal.
How similar studies have performed: Other ultrasound-guided interfascial plane blocks for abdominal surgery have reduced postoperative pain and opioid use, but direct head-to-head comparisons of M-TAPA versus RIFPB are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Çorum
- Hitit University — Çorum, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Hakan Akel, MD
- Email: drhakanakel@gmail.com
- Phone: +905442094827
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.