Actively Recruiting
Comparison of Ultrasound-Guided Modified Thoracoabdominal Nerve Block and Recto-Intercostal Fascial Plane Block for Pain Relief After Laparoscopic Gallbladder Surgery
Led by Hitit University · Updated on 2026-04-27
70
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two types of ultrasound-guided nerve blocks to manage pain after laparoscopic cholecystectomy, a common surgery to remove the gallbladder. This study focuses on the Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) and the Recto-Intercostal Fascial Plane Block (RIFPB), both aimed at reducing moderate-to-severe postoperative pain while avoiding opioid side effects. The trial is randomized, double-blind, and involves 70 patients aged 18 to 65 undergoing elective gallbladder removal due to gallstones. Participants receive either bilateral M-TAPA or RIFPB blocks under ultrasound guidance immediately after surgery while still under anesthesia. Both groups get 20 ml of 0.25% bupivacaine on each side, with M-TAPA targeting nerves around the 10th rib and RIFPB targeting the area below the xiphoid process. These blocks provide sensory nerve coverage to different areas of the abdomen to manage pain from surgical incisions and related sources. During the 24-hour postoperative period, pain intensity will be measured using the Numeric Rating Scale at multiple time points. Researchers will assess the area of sensory block with pinprick tests and record opioid use via tramadol patient-controlled analgesia. Additional monitoring includes nausea and vomiting scores, rescue medication use, and quality of recovery assessments before and after surgery. The study will help determine which block offers better pain relief and fewer side effects following gallbladder surgery.
CONDITIONS
Brief Title
USG-Guided TAPA vs RIFB Block for Postoperative Analgesia in Laparoscopic Cholecystectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65 years
- ASA physical classification I-II
- Body mass index (BMI) less than 35 kg/m²
- Scheduled for elective laparoscopic cholecystectomy due to gallstones
- Able to understand and use the Numeric Rating Scale (NRS) for pain
- Able to understand and use the QoR-15 recovery scale
- Able to communicate in Turkish
- Provided written informed consent
You will not qualify if you...
- Refusal to participate
- Body mass index (BMI) greater than 35 kg/m²
- ASA physical classification III-V
- Age under 18 or over 65 years
- Allergy to local anesthetics or study analgesics
- Pregnancy or breastfeeding
- Unable to understand or use NRS or QoR-15 scales
- Unable to communicate in Turkish
- Uncontrolled anxiety disorder
- Alcohol or drug dependency
- Neuromuscular or peripheral nerve disease
- High-dose opioid use within 3 days before surgery
- Widespread chronic pain
- Diabetes mellitus
- Liver or kidney failure
- Blood clotting disorders or anticoagulant use
- Infection at the block injection site
- Undergoing a second surgical procedure simultaneously
- History of previous abdominal surgery or trauma
- Conversion from laparoscopic to open surgery
- Problems with the patient-controlled analgesia device
- Persistent severe pain despite multimodal analgesia
- Planned postoperative non-extubation
- Surgery ended prematurely for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day
Participants undergo laparoscopic cholecystectomy followed by ultrasound-guided nerve blocks for postoperative pain relief applied after surgery while under anesthesia.
1 visit (in-person)
Duration - 24 hours postoperatively
Participants are monitored for pain relief, opioid consumption, and recovery quality through assessments including pain scales, dermatomal testing, and recovery questionnaires.
Visits at 0, 1, 2, 3, 6, 12, 18, and 24 hours post-surgery
Trial Site Locations
Total: 1 location
1
Hitit University
Çorum, Turkey (Türkiye), 19100
Actively Recruiting
Research Team
H
Hakan Akel, MD
A
Alperen KISA, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here