Clinical trial NCT06768593: Recto-Intercostal Fascial Plane (RIFP) Block in Laparoscopic Cholecystectomy Patients
Official title: Evaluation of the Effectiveness of Ultrasound-Guided Recto-Intercostal Fascial Plane (RIFP) Block in Postoperative Analgesia Management in Patients Undergoing Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Pain Management
Plane Block
Acute Pain
Keywords: pain management
Recto-Intercostal Fascial Plane (RIFP) Block
laparoscopic cholecystectomy
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rescue analgesic use
timeFrame: Need for rescue analgesics at 1, 3, 6, 12,18, and 24 hours postoperatively.
Secondary outcomes:
measure: Compare postoperative pain scores (Numeric Rating Scale - NRS scores)
timeFrame: NRS scores at rest and while moving will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively.
measure: Side effects and complications
timeFrame: Side effects and complications will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Mega Hospital Complex
state: Bagcilar
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.