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

Not Applicable

Recruiting

• Conditions: Laparoscopic Cholecystectomy; Pain Management; Plane Block; Acute Pain

• Registration Number: NCT06768593
• Lead Sponsor: Istanbul Medipol University Hospital

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.

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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-06
• Study First Posted: 2025-01-10
• Study Start: 2025-01-27
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rescue analgesic use	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.

Secondary Outcome Measures

Name	Time	Method
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.	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.
Side effects and complications	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.

Trial Locations

Locations (1)

Istanbul Medipol University Mega Hospital Complex; 🇹🇷 Istanbul, Bagcilar, Turkey