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Postoperative PainNCT07552701

USG-Guided TAPA vs RIFB Block for Postoperative Analgesia in Laparoscopic Cholecystectomy

A study testing M-TAPA Group and RIFPB Group in people with Postoperative Pain and Acute Cholecystitis, run by Hitit University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
M-TAPA Group and RIFPB Group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Jul 2025to 5 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 24Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hitit University

    Çorum

Other trials in Turkey (Türkiye)

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
M-TAPA Group, RIFPB Group
Keywords
Laparoscopic Cholecystectomy, Transversus abdominis Plane Block, Rectus-intercostalis facial plane block
Medical subject headings
Pain, Postoperative, Cholecystitis, Acute, Cholelithiasis, Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • M-TAPA GroupProcedure or surgery

    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.

  • RIFPB GroupProcedure or surgery

    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.

Study groups in NCT07552701
Study groupRoleWhat they receive
M-TAPA GroupActive comparatorM-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.
Receives: Procedure: M-TAPA Group
RIFPB GroupActive comparatorRIFPB 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.
Receives: Procedure: RIFPB Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 hours postoperatively

Secondary outcomes (13)
  1. 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).

    Measured: Postoperative hours 0, 1, 3, 6, 12, 18 and 24 (hour 0 = admission to the recovery room)

  2. 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).

    Measured: Postoperative hours 0, 1, 3, 6, 12, 18 and 24

  3. 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.

    Measured: Postoperative hours 2 and 24

  4. 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.

    Measured: First 24 hours postoperatively

  5. 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.

    Measured: Postoperative hours 0, 1, 3, 6, 12, 18 and 24

  6. 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.

    Measured: First 24 hours postoperatively

  7. 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.

    Measured: Preoperatively (morning of surgery) and at postoperative hour 24

  8. Patient Satisfaction

    Patient satisfaction rated on a 0-10 numeric scale (0 = not satisfied at all, 10 = completely satisfied).

    Measured: Postoperative hour 24

  9. Time to First Mobilization

    Time to first mobilization, defined as standing without assistance.

    Measured: First 24 hours postoperatively

  10. Time to First Oral Intake

    Time to the first postoperative oral intake.

    Measured: First 24 hours postoperatively

  11. Time to First Flatus and Defecation

    Time to the first postoperative passage of flatus and stool.

    Measured: First 24 hours postoperatively

  12. Interval Between Block Procedure and End of Anesthesia

    Time between the block procedure and the end of anesthesia.

    Measured: Day of surgery (intraoperative period)

  13. Time to First Rescue Analgesic

    Time to the first postoperative rescue analgesic requirement.

    Measured: First 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2026
  2. Study start10 Jul 2025
  3. Primary completion5 Jun 2026
  4. Study completion5 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients undergoing laparoscopic cholecystectomy are randomly assigned to two parallel groups: Group M (bilateral M-TAPA) and Group R (bilateral RIFPB), to compare postoperative analgesic efficacy.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07552701
Sponsor's protocol ID
2025-151
Status last verified
Oct 2026
First submitted
20 Apr 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing M-TAPA Group and RIFPB Group in people with Postoperative Pain and Acute Cholecystitis, run by Hitit University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Opioid Consumption (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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