Trials / Completed
CompletedNCT07253610
Effect of Bilateral Rectointercostal Fascial Plane Block on Postoperative Pain After Laparoscopic Sleeve Gastrectomy
Investigation of the Effects of Bilateral Rectointercostal Fascial Plane Block on Postoperative Acute Pain in Patients Undergoing Laparoscopic Sleeve Gastrectomy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Samsun University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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. |
| 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. |
Timeline
- Start date
- 2025-11-01
- Primary completion
- 2025-12-21
- Completion
- 2025-12-21
- First posted
- 2025-11-28
- Last updated
- 2025-12-29
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07253610. Inclusion in this directory is not an endorsement.