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

November 24, 2025 updated by: Ayse Ince, Istanbul Medipol University Hospital

Evaluation of the Effectiveness of Ultrasound-Guided Recto-Intercostal Fascial Plane (RIFP) Block in Postoperative Analgesia Management in Patients Undergoing Laparoscopic Cholecystectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cholecystectomy is the most common abdominal surgical procedure performed in developed countries and is usually performed laparoscopically. Many factors play a role in the pain that develops after laparoscopic cholecystectomy and it has both somatic and visceral components. Phrenic nerve irritation as a result of CO₂ insufflation into the peritoneal cavity, abdominal distension, tissue trauma, trauma due to gallbladder removal, sociocultural differences, and individual factors are the factors that play a role in the emergence of this pain. Postoperative pain is an acute pain that is accompanied by an inflammatory process that occurs due to surgical trauma and gradually decreases with tissue healing. Pain in the postoperative period in patients undergoing laparoscopic cholecystectomy is a serious problem that reduces patient comfort and delays the patient's return to normal life after surgery. Effective postoperative pain management prevents many effects such as shallow breathing and delayed mobilization.

RIFPB performed with ultrasound (US) guidance is a new abdominal plane block. The rectus muscle attaches to the cartilage of the 7th rib in the epigastrium on the cranial side. Injecting local anesthetic between the 7th rib and the rectus muscle provides effective analgesia in the sternal, epigastric, and upper abdominal areas. It can be used as a complementary block for thorax, and a stand-alone technique for the abdomen. RIFPB provides analgesia at T6-T10/11 dermatome levels for lateral and medial cutaneous branches. Visualizing son anatomy with US is easy and the spread of local anesthetic can be easily detected. According to the literature, there are case series reporting RIFPB to be effective in cardiac surgery, and sternum revision surgery, both for postoperative analgesia management and as a sole anesthetic method alone. The investigators hypothesize that this block can provide effective postoperative analgesia in laparoscopic cholecystectomy operations due to its mechanism of action. This study aims to evaluate the effectiveness of USG-guided RIFB block for primary postoperative analgesia management after laparoscopic cholecystectomy surgery.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Bagcilar
      • Istanbul, Bagcilar, Turkey (Türkiye), 34212
        • Istanbul Medipol University Mega Hospital Complex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria: patients with

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group R = RIFP Block group
RIFP block will be performed and standard postoperative pain management protocols will be applied.
Procedure: RIFP Block
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.
Other: Postoperative pain management

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.
Active Comparator: Group K = Control group
Standard postoperative pain management protocols will be applied. No plane block will be applied.
Other: Postoperative pain management

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rescue analgesic use
Time Frame: Need for rescue analgesics at 1, 3, 6, 12,18, and 24 hours postoperatively.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects and complications
Time Frame: Side effects and complications will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively
Side effects such as nausea, vomiting, sedations, and complications (hematoma, pneumothorax, etc.) will be recorded.
Side effects and complications will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively
Compare postoperative pain scores (Numeric Rating Scale - NRS scores)
Time Frame: NRS scores at rest and while moving will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively.

The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginabl. Higher pain scores mean worse outcome.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2025

Primary Completion (Actual)

October 6, 2025

Study Completion (Actual)

October 6, 2025

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

January 10, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Medipol Hospital 4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators will not share individual patient data (IPD).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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