Ultrasound-Guided Regional Blocks for Postoperative Analgesia After Laparoscopic Cholecystectomy

NCT07321639 | Not Yet Recruiting

• 1 other identifier: Medipol Hospital 7
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Ultrasound (US)-guided recto-intercostal fascial plane block (RIFPB) is a recently described abdominal wall block performed by injecting local anesthetic between the rectus abdominis muscle and the costal cartilage of the 7th rib. Due to the cranial attachment of the rectus muscle, this technique provides effective analgesia to the sternal, epigastric, and upper-mid abdominal regions, corresponding to the T6-T10/11 dermatomal levels. RIFPB may be used as an adjunct technique for thoracic procedures or as a standalone block for abdominal surgery. Ultrasound-guided transversus abdominis plane block (TAPB) is performed by injecting local anesthetic into the fascial plane between the internal oblique and transversus abdominis muscles. TAPB provides sensory blockade of the anterolateral abdominal wall at the T6-L1 dermatomal levels and is widely used for postoperative analgesia following abdominal surgeries, including laparoscopic cholecystectomy. This study aims to compare the effectiveness of US-guided RIFPB and TAPB on postoperative pain control after laparoscopic cholecystectomy.

Conditions

Laparoscopic Cholecystectomy; Acute Pain; Pain Management; Plane Blocks

Keywords

Laparoscopic cholecystectomy; Postoperative analgesia; Recto-intercostal fascial plane block; Transversus abdominis plane block; Regional anesthesia; Opioid consumption

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  Total postoperative opioid consumption will be recorded for each patient during the first 24 hours after surgery. Opioid use will be quantified based on the total dose of rescue opioid analgesics administered and compared between study groups to assess differences in postoperative opioid requirements.

  During the first 24 hours postoperatively

Secondary Outcomes (3)

• Postoperative pain scores

  Postoperative hours 1, 3, 6, 12, 18, and 24.

• Adverse events

  During the first 24 hours postoperatively

• Postoperative Rescue Analgesic Consumption:

  During the first 24 hours postoperatively

Study Arms (3)

Recto-intercostal fascial plane block

ACTIVE COMPARATOR

RIFP block will be performed, and standard postoperative pain management protocols will be applied.

Procedure: Recto-Intercostal Fascial Plane Block; Other: Post-operative Pain Management

Transversus abdominis plane block

ACTIVE COMPARATOR

TAP block will be performed, and standard postoperative pain management protocols will be applied.

Procedure: Transversus- Abdominis Plane Block; Other: Post-operative Pain Management

Control group

ACTIVE COMPARATOR

Standard postoperative pain management protocols will be applied. No plane block will be applied.

Other: Post-operative Pain Management

Interventions

Recto-Intercostal Fascial Plane Block PROCEDURE

The block will be performed under general anesthesia immediately before extubation, with the patient in the supine position under ultrasound guidance (Vivid Q). After aseptic preparation, a high-frequency linear probe (11-12 MHz) covered with a sterile sheath and an 80-mm block needle (Braun 360°) will be used. The probe will be positioned to identify the xiphoid process, rectus abdominis muscle, and sixth costal cartilage. Using an in-plane technique, the needle will be advanced in a caudal-to-cephalic direction. After confirmation of correct needle placement with 5 mL saline, 20 mL of 0.25% bupivacaine (Buvacaine, Polifarma ®) will be injected on each side (total volume 40 mL).

Also known as: RIFPB

Recto-intercostal fascial plane block

Transversus- Abdominis Plane Block PROCEDURE

The transversus abdominis plane block will be performed immediately after completion of surgery and before extubation, with the patient in the supine position under ultrasound guidance( Vivid Q). Following aseptic preparation, a high-frequency linear probe (11-12 MHz) and an 80-mm block needle (Braun 360°) will be used to identify the abdominal wall muscle layers at the anterior axillary line between the 12th rib and the iliac crest. Using an in-plane technique, the needle will be advanced into the plane between the internal oblique and transversus abdominis muscles. After confirmation of correct needle placement with 5 ml saline injection, 20 mL of 0.25% bupivacaine (Buvacaine, Polifarma ®) will be administered to each side (total volume 40 mL).

Also known as: TAPB

Transversus abdominis plane block

Post-operative Pain Management OTHER

Thirty minutes before the end of surgery, all patients will receive the standard postoperative analgesia regimen consisting of intravenous ibuprofen 400 mg (Intrafen®) and intravenous tramadol 100 mg (Contramal®). Postoperative patient assessment will be performed by an anesthesiologist who is not involved in the intervention.If the patient's NRS score is ≥4 at any time point, intravenous meperidine (Aldolan®) at a dose of 0.5 mg/kg will be administered as rescue analgesia.

Control group; Recto-intercostal fascial plane block; Transversus abdominis plane block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I-II
• Scheduled for elective laparoscopic cholecystectomy

You may not qualify if:

• Known allergy to local anesthetics or opioid medications
• Infection at the planned block site
• History of alcohol or drug dependence
• Use of anticoagulant therapy
• Refusal to participate in the study

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• Ciftci B, Omur B, Alver S, Akin AN, Yildiz Y, Tulgar S. The Medipol Combination: Novel Rectointercostal Fascial Plane Block and Pectointercostal Fascial Plane Block for Postoperative Analgesia Management After Cardiac Surgery: A Report of 15 Cases. A A Pract. 2024 Jun 5;18(6):e01794. doi: 10.1213/XAA.0000000000001794. eCollection 2024 Jun 1.

  PMID: 38836555 BACKGROUND

• Dost B, Turunc E, Ozdemir E. Subxiphoid Pericardial Window Using a Combination of Rectointercostal Fascial Plane Block and Superficial Parasternal Intercostal Plane Block. J Cardiothorac Vasc Anesth. 2024 May;38(5):1282-1283. doi: 10.1053/j.jvca.2024.02.002. Epub 2024 Feb 4. No abstract available.

  PMID: 38453556 BACKGROUND

• Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31.

  PMID: 29226150 BACKGROUND

• Brogi E, Kazan R, Cyr S, Giunta F, Hemmerling TM. Transversus abdominal plane block for postoperative analgesia: a systematic review and meta-analysis of randomized-controlled trials. Can J Anaesth. 2016 Oct;63(10):1184-1196. doi: 10.1007/s12630-016-0679-x. Epub 2016 Jun 15.

  PMID: 27307177 BACKGROUND

• El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17.

  PMID: 19376789 BACKGROUND

MeSH Terms

Conditions

Acute Pain; Agnosia

Interventions

1,3-bis(4-amidinophenoxy)-2-(4-amidinophenoxymethyl)ethylpropane

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

ayşe ince, Assist Prof

CONTACT

00905366774988; drayseince@gmail.com

Tumay Uludag Yanaral, Assoc Prof

CONTACT

000905052422100; uludagt@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor and participants will be blinded to the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Ninety patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled to undergo laparoscopic cholecystectomy will be included in the study. Patients will be randomly assigned to three groups before entering the operating room: the recto-intercostal fascial plane block group (Group RIFPB), the transversus abdominis plane block group (Group TAPB), and the control group, with 30 patients in each group.

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)