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NCT07841951
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Conditions: Postoperative Pain, Acute Pain, Cholelithiasis, Anesthesia
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: Medipol University
Location: Istanbul Medipol University Mega Hospital Complex, Department of Anesthesiology and Reanimation Istanbul
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.
Eligibility Criteria
Inclusion Criteria:
* Aged 18 to 75 years
* American Society of Anesthesiologists (ASA) physical status I or II
* Scheduled for elective laparoscopic cholecystectomy under general anesthesia
* Body weight above 60 kg
* Able and willing to provide written informed consent
Exclusion Criteria:
* Known allergy to local anesthetics or opioids
* Coagulopathy or use of anticoagulant medication
* Infection or skin lesion at the block injection site
* Alcohol or substance dependence, or chronic opioid use
* Pregnancy or breastfeeding
* Advanced hepatic or renal failure
* Any condition that prevents understanding of the numeric rating scale or communication (e.g., cognitive impairment)
* Refusal to participate
Source: ClinicalTrials.gov (NCT07841951). StuddyBuddy aggregates publicly available trial information.