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

NCT ID: NCT07253610

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2025-12-21

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.

Detailed Description

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.

Conditions

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

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bilateral Rectointercostal Fascial Plane Block Group

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.

Group Type: EXPERIMENTAL

Bilateral Rectointercostal Fascial Plane Block

Intervention Type: 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

Intervention Type: 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.

Control Group (General Anesthesia + PCA)

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.

Group Type: ACTIVE_COMPARATOR

Intravenous Patient-Controlled Analgesia (IV PCA) with Morphine

Intervention Type: 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.

Interventions

Bilateral Rectointercostal Fascial Plane Block

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.

Intervention Type: OTHER

Intravenous Patient-Controlled Analgesia (IV PCA) with Morphine

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Samsun University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istinye University Faculty of Medicine, Medical Park Gaziosmanpasa Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Istinye Univesitesi HREC

Identifier Type: -

Identifier Source: org_study_id