An interventional study of M-TAPA Group and RIFPB Group in Postoperative Pain, Acute Cholecystitis and Cholelithiasis, sponsored by Hitit University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Hitit University · Not applicable, Interventional, and Supportive care
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.
The gallbladder is a small organ located in the right upper quadrant of the abdomen that stores bile, which aids in food digestion. Gallstones form as a result of changes in bile composition caused by hormones, medications, diet, and weight fluctuations. When a gallstone obstructs the cystic duct, acute cholecystitis develops, leading to gallbladder distension and inflammation. Cholecystectomy is the standard surgical treatment performed worldwide for this condition.
Management of acute cholecystitis is either medical - consisting of bed rest, analgesics, antibiotherapy, and intravenous fluid replacement - or surgical, involving removal of the gallbladder. While the procedure can be performed via open or laparoscopic technique, laparoscopic cholecystectomy (LC) is superior in terms of less incisional pain, shorter hospital stay, improved quality of life, and faster recovery.
Despite being minimally invasive, LC can cause moderate-to-severe postoperative pain. The majority originates from incision sites (50-70%), with additional contributions from pneumoperitoneum (20-30%) and the cholecystectomy itself (10-20%). Severe pain leads to delayed mobilization, reduced patient satisfaction, chronic pain development, and increased pulmonary and cardiac complications. A multimodal analgesic approach is therefore recommended. Although NSAIDs, paracetamol, opioids, and local anesthetics are commonly used, opioids carry significant risks including postoperative nausea and vomiting (PONV), constipation, and respiratory depression. Neuraxial analgesia is rarely preferred due to potential complications and technical difficulties.
Ultrasound-guided interfascial plane blocks have gained increasing use in LC due to their safety and efficacy. The anterolateral abdominal wall is composed of the rectus abdominis, external oblique, internal oblique, and transversus abdominis muscles. The transversus abdominis plane contains the T6-L1 thoracolumbar nerves between the internal oblique and transversus abdominis muscles, and local anesthetic injection into this plane provides T7-L1 sensory blockade.
The Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA), introduced by Tulgar et al., applies local anesthetic solely to the inferior surface of the costochondral perichondrium at the 9th-10th rib level under ultrasound guidance, targeting T4/T5-T12/L1 thoracoabdominal nerves. It blocks anterior and lateral cutaneous branches to provide abdominal analgesia, with reported efficacy in both minor and major abdominal surgeries.
The Recto-Intercostal Fascial Plane Block (RIFPB), also described by Tulgar et al. in 2023, deposits local anesthetic into the interfascial plane between the rectus abdominis muscle and the 6th-7th costal cartilages, just below the xiphoid process. Methylene blue studies have demonstrated significant spread to the anterior cutaneous branches of T6-T9 and laterally, covering nearly the entire upper anterolateral abdomen. Based on these findings, 20 ml of local anesthetic will be used for RIFPB in this study, targeting T6-T9 dermatomal coverage.
This prospective, randomized, double-blind study aims to compare the postoperative analgesic efficacy of bilateral M-TAPA versus bilateral RIFPB in 70 patients (35 per group) undergoing LC. Both blocks will be applied under ultrasound guidance using 20 ml of 0.25% bupivacaine bilaterally after surgery while patients remain under anesthesia.
Postoperative pain will be assessed using the Numeric Rating Scale (NRS) at 0, 1, 3, 6, 12, 18, and 24 hours. Dermatomal spread will be evaluated at postoperative 2nd and 24th hours via pinprick testing across T3-L1 levels. Opioid consumption will be recorded via tramadol PCA at 0-1, 1-12, 12-24 hours, and total 24 hours. PONV will be monitored using a 4-point scale, and ondansetron rescue doses will be recorded. Quality of recovery will be assessed using the QoR-15 scale (scored 0-150) preoperatively and at 24 hours postoperatively, evaluating physical comfort, pain, physical independence, psychological support, and emotional state.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 81 is close to the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Hitit University is the lead sponsor of 87 studies on the registry; 29 are open to participants now.
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The criteria were revised on the registry on Sep 25, 2026. See what changed
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
M-TAPA Group: Patients receiving ultrasound-guided bilateral Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) using 20 ml of 0.25% bupivacaine per side, applied at the 10th rib level beneath the costochondral perichondrium after surgery while under anesthesia.
Procedure: M-TAPA Group
RIFPB Group: Patients receiving ultrasound-guided bilateral Recto-Intercostal Fascial Plane Block (RIFPB) using 20 ml of 0.25% bupivacaine per side, injected into the interfascial plane between the rectus abdominis muscle and the 6th-7th costal cartilages just below the xiphoid process, applied after surgery while under anesthesia.
Procedure: RIFPB Group
Patients receiving ultrasound-guided bilateral Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) using 20 ml of 0.25% bupivacaine per side, applied at the 10th rib level beneath the costochondral perichondrium after surgery while under anesthesia.
Patients receiving ultrasound-guided bilateral Recto-Intercostal Fascial Plane Block (RIFPB) using 20 ml of 0.25% bupivacaine per side, injected into the interfascial plane between the rectus abdominis muscle and the 6th-7th costal cartilages just below the xiphoid process, applied after surgery while under anesthesia.
Postoperative Opioid Consumption
Total tramadol consumption (mg) via patient-controlled analgesia (PCA) recorded at 0-1, 1-12, 12-24 hours, and total 24 hours postoperatively.
Time frame: 24 hours postoperatively
Pain Intensity at Rest (NRS)
Pain intensity at rest assessed with the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Postoperative hours 0, 1, 3, 6, 12, 18 and 24 (hour 0 = admission to the recovery room)
Pain Intensity on Movement (NRS)
Pain intensity during active movement, defined as moving from the supine to the sitting position, assessed with the Numeric Rating Scale (NRS), 0-10. an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Postoperative hours 0, 1, 3, 6, 12, 18 and 24
Sensory Block Level (Dermatomal Spread)
Sensory block level assessed by pinprick testing across the T3-L1 dermatomes along the midclavicular line, right and left sides evaluated separately, using a 3-point scale (0 = no pain, 1 = reduced pain, 2 = normal pain). Scores of 0 or 1 were defined as effective block. Normal sensation at the shoulder was used as the reference.
Time frame: Postoperative hours 2 and 24
Rescue Analgesic Requirement
Number of rescue analgesic administrations and total rescue analgesic dose. Intravenous fentanyl 25 mcg was administered when the NRS score exceeded 4.
Time frame: First 24 hours postoperatively
Postoperative Nausea and Vomiting (PONV) Score
Nausea and vomiting assessed with a 4-point score: 1 = no nausea or vomiting; 2 = nausea without vomiting; 3 = one episode of vomiting or persistent nausea; 4 = two or more episodes of vomiting or severe/continuous retching.
Time frame: Postoperative hours 0, 1, 3, 6, 12, 18 and 24
Ondansetron Requirement
Total intravenous ondansetron dose administered. Ondansetron 4 mg was given for a PONV score of 2 or higher, with at least 4 hours between repeated doses.
Time frame: First 24 hours postoperatively
Quality of Recovery (QoR-15T)
Quality of recovery assessed with the Turkish version of the 15-item Quality of Recovery questionnaire (QoR-15T). The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
Time frame: Preoperatively (morning of surgery) and at postoperative hour 24
Patient Satisfaction
Patient satisfaction rated on a 0-10 numeric scale (0 = not satisfied at all, 10 = completely satisfied).
Time frame: Postoperative hour 24
Time to First Mobilization
Time to first mobilization, defined as standing without assistance.
Time frame: First 24 hours postoperatively
Time to First Oral Intake
Time to the first postoperative oral intake.
Time frame: First 24 hours postoperatively
Time to First Flatus and Defecation
Time to the first postoperative passage of flatus and stool.
Time frame: First 24 hours postoperatively
Interval Between Block Procedure and End of Anesthesia
Time between the block procedure and the end of anesthesia.
Time frame: Day of surgery (intraoperative period)
Time to First Rescue Analgesic
Time to the first postoperative rescue analgesic requirement.
Time frame: First 24 hours postoperatively
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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