Recto-Intercostal Fascial Plane (RIFP) Block in Laparoscopic Cholecystectomy Patients

NCT06768593 | Completed

• 1 other identifier: Medipol Hospital 4
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Ultrasound-guided Recto-Intercostal Fascial Plane (RIFP) Block is performed by injecting local anesthetic deep between the 7th rib and the costochondral aspect of the rectus muscle. It provides blockage of both the anterior and lateral cutaneous branches of T6-T10/11 and analgesia of the sternum, epigastrium, and upper abdomen (1). Studies show that RIFP block is effective for postoperative analgesia, sternum revision, and cardiac surgery. However, its effect on patients undergoing laparoscopic cholecystectomies has not been studied yet. The investigators hypothesize that RIFP block performed in laparoscopic cholecystectomies would reduce postoperative rescue analgesic use and postoperative opioid consumption in the first 24 hours after surgery.

Conditions

Laparoscopic Cholecystectomy; Pain Management; Plane Block; Acute Pain

Keywords

pain management; Recto-Intercostal Fascial Plane (RIFP) Block; laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Rescue analgesic use

  The primary aim is to investigate postoperative rescue analgesic use and postoperative opioid consumption.

  Need for rescue analgesics at 1, 3, 6, 12,18, and 24 hours postoperatively.

Secondary Outcomes (2)

• Compare postoperative pain scores (Numeric Rating Scale - NRS scores)

  NRS scores at rest and while moving will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively.

• Side effects and complications

  Side effects and complications will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively

Study Arms (2)

Group R = RIFP Block group

EXPERIMENTAL

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

Procedure: RIFP Block; Other: Postoperative pain management

Group K = Control group

ACTIVE COMPARATOR

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

Other: Postoperative pain management

Interventions

RIFP Block PROCEDURE

After aseptic conditions are ensured, with high-frequency linear US probe (11-12 MHz, Vivid Q) and a 22-G 80-mm needle (Pajunk Sonoplex Nanoline Stim Cannula, Germany) bilateral block will be applied to Group R. As the patient is in supine position, the USG probe is placed in transverse plane on the sternum and will be directed downwards and laterally and rotated to determine the xiphoid and just below the rectus abdominis muscles. Costal cartilage and rectus abdominis muscle sonographically will be shown. This region corresponds to the 3-4 cm lateral and 3-4 cm caudal region of the xiphoid. Using the in-plane technique, the block needle will be advanced in the caudal-cephalic direction, and 5 ml saline will be injected into the area between the rectus muscle and costal cartilage to verify the block location. 30 ml of 0.25% bupivacaine (Buvacaine, Polifarma ®) will be injected to each side, which corresponds to 60 ml total local anesthetic-saline mixture in Group R.

Group R = RIFP Block group

Postoperative pain management OTHER

Ibuprofen 400 mg (Ibuprofen, Polifarma ®) and tramadol 100 mg (Contramal, Abdi İbrahim ®) IV single bolus dose will be given 20 minutes before the end of the surgical procedure for postoperative analgesia. NRS scores at rest and while moving will be evaluated and recorded and if the NRS score is ≥ 4, meperidine 0,5 mg/kg (Aldolan®) IV will be administered as a rescue analgesic.

Group K = Control group; Group R = RIFP Block group

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologists (ASA) classification I-II patients
• Laparoscopic cholecystectomy operation under general anesthesia

You may not qualify if:

• with a history of bleeding diathesis
• v receiving anticoagulant treatment,
• with allergies or sensitivity to drugs used,
• with an infection on the puncture site
• with a history of alcohol or drug addiction,
• with congestive heart failure
• with liver or kidney disease
• who do not accept the procedure or participate in the study

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University Mega Hospital Complex

Istanbul, Bagcilar, 34212, Turkey (Türkiye)

Location

Related Publications (3)

• 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 RESULT

• 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 RESULT

• Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Alver S, Sakul BU, Ansen G, Pence KB, Alici HA. Recto-intercostal fascial plane block: Another novel fascial plane block. J Clin Anesth. 2023 Oct;89:111163. doi: 10.1016/j.jclinane.2023.111163. Epub 2023 Jun 7. No abstract available.

  PMID: 37295124 RESULT

MeSH Terms

Conditions

Agnosia; Acute Pain; Bites and Stings

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Design

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

Model Details: Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification II-III, scheduled for laparoscopic cholecystectomy operation will be included in the study. Patients will be randomly divided into two groups (Group R=RIFP block group, Group K = control group) including 30 patients each, before entering the operating room.

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: January 27, 2025
• Primary Completion: October 6, 2025
• Study Completion: October 6, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)