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NCT Number: NCT07253610

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

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.

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Key information

Conditions

Pain, Postoperative Body Weight Laparoscopic Sleeve Gastrectomy (LSG) Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Opioid Use Overnutrition Overweight Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istinye University Faculty of Medicine, Medical Park Gaziosmanpasa Hospital

Istanbul, Turkey (Türkiye)

About this study

Adequate pain relief in the postoperative period is a crucial determinant of patient comfort, early mobilization, and overall recovery after laparoscopic sleeve gastrectomy. Effective analgesia not only enhances patient satisfaction but also reduces postoperative complications, facilitates respiratory function, and shortens hospital stay. Conversely, inadequate pain control may lead to delayed mobilization, nausea, vomiting, increased opioid requirements, and prolonged recovery.

In recent years, regional anesthesia techniques, particularly abdominal wall and fascial plane blocks, have become an integral part of multimodal analgesia strategies designed to reduce opioid consumption and minimize related adverse effects. The rectointercostal fascial plane (RIB) block, first described by Tulgar et al. in 2023, is a novel regional technique that targets the thoracoabdominal intercostal nerves by injecting local anesthetic between the rectus abdominis and intercostal muscles at the level of the costal cartilage. This block has shown promising results in providing effective postoperative analgesia after upper abdominal laparoscopic surgeries.

The present randomized controlled study was designed to evaluate the effectiveness of the bilateral rectointercostal fascial plane block compared with standard intravenous patient-controlled analgesia in patients undergoing laparoscopic sleeve gastrectomy. The primary outcome is total opioid consumption during the first 24 postoperative hours, and the secondary outcomes include pain scores at rest and during movement, patient satisfaction, incidence of postoperative nausea and vomiting, and block-related complications.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Cumulative Opioid Consumption in the First 24 Hours After Surgery

    Time frame: Postoperative day 1 (0-24 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

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

Investigation of the Effects of Bilateral Rectointercostal Fascial Plane Block on Postoperative Acute Pain in Patients Undergoing Laparoscopic Sleeve Gastrectomy

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 28, 2025
Registry last updated
Dec 29, 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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