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

M

Medipol Health Group

Status

Completed

Conditions

Laparoscopic Cholecystectomy
Pain Management
Plane Block
Acute Pain

Treatments

Other: Postoperative pain management
Procedure: RIFP Block

Study type

Interventional

Funder types

Other

Identifiers

NCT06768593
Medipol Hospital 4

Details and patient eligibility

About

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.

Full 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.

Enrollment

77 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

77 participants in 2 patient groups

Group R = RIFP Block group
Experimental group
Description:
RIFP block will be performed and standard postoperative pain management protocols will be applied.
Treatment:
Procedure: RIFP Block
Other: Postoperative pain management
Group K = Control group
Active Comparator group
Description:
Standard postoperative pain management protocols will be applied. No plane block will be applied.
Treatment:
Other: Postoperative pain management

Trial contacts and locations

1

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Central trial contact

AYSE INCE, Assist Prof; HANDE GUNGOR DANISAN, Assist Prof

Data sourced from clinicaltrials.gov

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