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NCT Number: NCT06768593

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

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.

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Key information

Conditions

Laparoscopic Cholecystectomy Acute Pain Agnosia Bites and Stings Chemically-Induced Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Plane Block Poisoning Signs and Symptoms Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University Mega Hospital Complex

Istanbul, Bagcilar, 34212, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

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

Acronym: RIFPB

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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