Effect of Bilateral Rectointercostal Fascial Plane Block on Postoperative Pain After Laparoscopic Sleeve Gastrectomy

NCT07253610 | Completed

• 1 other identifier: Istinye Univesitesi HREC
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled study aims to evaluate the effectiveness of the bilateral rectointercostal fascial plane (RIB) block for postoperative pain management in patients undergoing laparoscopic sleeve gastrectomy. The study compares RIB block combined with standard general anesthesia to standard intravenous patient-controlled analgesia alone. The primary outcome is total opioid consumption within the first 24 postoperative hours, while secondary outcomes include pain scores, patient satisfaction, postoperative nausea and vomiting, and block-related complications.

Conditions

Pain, Postoperative; Obesity, Morbid; Laparoscopic Sleeve Gastrectomy (LSG); Opioid Use

Keywords

Rectointercostal Fascial Plane Block; Laparoscopic Sleeve Gastrectomy; Morbid Obesity; Opioid Consumption

Outcome Measures

Primary Outcomes (1)

• Cumulative Opioid Consumption in the First 24 Hours After Surgery

  The primary outcome is defined as the total cumulative opioid consumption during the first 24 hours after surgery. Opioid use will be recorded as the total amount of morphine administered via intravenous patient-controlled analgesia (PCA). Patients will be instructed to request analgesia through the PCA device whenever their numeric rating scale (NRS) pain score is ≥4. No basal infusion will be used

  Postoperative day 1 (0-24 hours after surgery)

Study Arms (2)

Bilateral Rectointercostal Fascial Plane Block Group

EXPERIMENTAL

Participants in this group will receive bilateral rectointercostal fascial plane (RIB) block under ultrasound guidance prior to induction of general anesthesia. Following surgery, standard intravenous patient-controlled analgesia (PCA) with morphine will be administered.

Other: Bilateral Rectointercostal Fascial Plane Block; Other: Intravenous Patient-Controlled Analgesia (IV PCA) with Morphine

Control Group (General Anesthesia + PCA)

ACTIVE COMPARATOR

Participants in this group will receive only general anesthesia followed by standard intravenous patient-controlled analgesia (PCA) with morphine. No fascial plane block will be performed.

Other: Intravenous Patient-Controlled Analgesia (IV PCA) with Morphine

Interventions

Bilateral Rectointercostal Fascial Plane Block OTHER

Under ultrasound guidance, 30 mL of local anesthetic will be injected bilaterally between the rectus abdominis and intercostal muscles at the level of the 6th-7th costal cartilages to achieve rectointercostal fascial plane block prior to general anesthesia.

Bilateral Rectointercostal Fascial Plane Block Group

Intravenous Patient-Controlled Analgesia (IV PCA) with Morphine OTHER

For all groups, intravenous patient-controlled analgesia (IV PCA) will be initiated in the post-anesthesia care unit (PACU) using a BodyGuard 575 Pain Manager (UK). The total morphine consumption during the first 24 hours postoperatively will be recorded. The PCA regimen will be standardized as follows: no basal infusion, a 1 mg morphine bolus dose, a lock-out interval of 15 minutes, and a maximum dose limit of 10 mg within 4 hours. Approximately 45 minutes before the end of surgery, patients will receive 1 g paracetamol, 20 mg tenoxicam, and 3.5 mg morphine intravenously. Postoperatively, paracetamol will be administered every 8 hours and tenoxicam every 12 hours. This postoperative pain management strategy reflects the standard protocol routinely used in our clinic.

Bilateral Rectointercostal Fascial Plane Block Group; Control Group (General Anesthesia + PCA)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years
• Body mass index (BMI) \> 35 kg/m²
• American Society of Anesthesiologists (ASA) physical status II-III
• Scheduled for elective laparoscopic sleeve gastrectomy under general anesthesia
• Provided written informed consent to participate in the study

You may not qualify if:

• Chronic opioid use or dependence
• History of chronic pain
• Known allergy or contraindication to local anesthetics or opioids
• Severe cardiac, hepatic, or renal disease
• Severe psychiatric disorder (e.g., psychosis, dementia)
• STOP-BANG score ≥ 5 (high risk for obstructive sleep apnea)
• Block failure or incomplete block after local anesthetic injection

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Istinye University Faculty of Medicine, Medical Park Gaziosmanpasa Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Obesity, Morbid

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blind design: Participants and the outcomes assessor were blinded to group allocation. The anesthesiologist performing the block was not blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, double-blind, parallel-group study involving two arms. The RIB group will receive bilateral rectointercostal fascial plane block in addition to standard general anesthesia and intravenous patient-controlled analgesia (PCA), while the control group will receive only general anesthesia and PCA.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: November 1, 2025
• Primary Completion: December 21, 2025
• Study Completion: December 21, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

TU (1)