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Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Sponsor: Medipol University
Summary
Pain after laparoscopic cholecystectomy remains clinically relevant, and current recommendations favour multimodal, opioid-sparing analgesia including regional techniques. The recto-intercostal fascial plane block (RIFPB) is a recently described technique in which local anesthetic is injected into the plane between the rectus abdominis muscle and the 6th and 7th costal cartilages, targeting the anterior and lateral cutaneous branches of the sixth to ninth thoracic (T6-T9) thoracoabdominal nerves. In the investigators' previous randomized controlled trial, bilateral RIFPB after laparoscopic cholecystectomy significantly reduced the need for rescue analgesia (17.9% versus 55.3%) and pain scores during the first 12 postoperative hours. That trial used 30 mL of 0.25% bupivacaine per side (60 mL, 150 mg in total), a dose approaching the recommended upper limit, and whether lower doses provide comparable analgesia remains unknown. Because fascial plane blocks depend on local anesthetic spread, large volumes are preferred, increasing the total dose and the risk of local anesthetic systemic toxicity (LAST); lowering the concentration as volume increases has therefore been recommended. Equal-volume studies of transversus abdominis plane and erector spinae plane blocks suggest that lower concentrations provide comparable analgesia, but no study has compared concentrations for RIFPB. This trial will compare, at a fixed volume of 25 mL per side (50 mL in total), bilateral RIFPB with 0.25% bupivacaine (125 mg), bilateral RIFPB with 0.125% bupivacaine (62.5 mg), and routine port-site infiltration with 25 mL of 0.25% bupivacaine without a block (control) in adults undergoing elective laparoscopic cholecystectomy under general anesthesia. Ninety patients will be randomly allocated in a 1:1:1 ratio. The primary outcome is total rescue tramadol consumption during the first 24 postoperative hours. Secondary outcomes include numeric rating scale (NRS) pain scores at rest and on movement (coughing), the need for and time to first rescue analgesia, nausea, vomiting and pruritus, block-related complications and signs of LAST, patient satisfaction, and length of hospital stay. The investigators hypothesize that RIFPB at either concentration will reduce rescue tramadol consumption and pain scores compared with control, and that the lower concentration will halve the total bupivacaine dose (62.5 mg instead of 125 mg), thereby reducing the risk of LAST.
Official title: Effect of Two Different Bupivacaine Concentrations in Recto-Intercostal Fascial Plane Block on Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized, Controlled, Double-Blind Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2027-01-30
Completion Date
2027-06-15
Last Updated
2026-10-29
Healthy Volunteers
No
Interventions
Bupivacaine 0.25% - recto-intercostal fascial plane block
Bilateral ultrasound-guided recto-intercostal fascial plane block (RIFPB) with a high-frequency linear probe (11-12 MHz) and a 22-gauge, 80 mm block needle. The probe is placed 3-4 cm lateral and caudal to the epigastrium to visualize the rectus abdominis muscle and the 6th and 7th costal cartilages; after in-plane hydrodissection with 5 mL of saline, 25 mL of 0.25% bupivacaine is injected on each side (50 mL, 125 mg in total). The solution is prepared by diluting 25 mL of 0.5% bupivacaine with 25 mL of 0.9% saline. Aspiration is performed before injection and after every 5 mL, and the drug is given in fractionated doses.
Bupivacaine 0.125% - recto-intercostal fascial plane block
Bilateral ultrasound-guided recto-intercostal fascial plane block (RIFPB) performed with the identical technique and the identical volume as in Group Y, using 25 mL of 0.125% bupivacaine per side (50 mL, 62.5 mg in total). The solution is prepared by diluting 12.5 mL of 0.5% bupivacaine with 37.5 mL of 0.9% saline.
Bupivacaine 0.25% - port-site infiltration
Routine institutional practice: infiltration of the laparoscopic port sites by the surgical team with 25 mL of 0.25% bupivacaine (62.5 mg). No fascial plane block is performed.
Locations (1)
Istanbul Medipol University Mega Hospital Complex, Department of Anesthesiology and Reanimation
Istanbul, Turkey (Türkiye)