Recto-intercostal fascial plane block for pain control during laparoscopic gallbladder removal
Recto-intercostal Fascial Plane Block Reduces Intraoperative Opioid and Volatile Anesthetic Use: a Randomized Trial in Cholecystectomy
This will test whether an ultrasound-guided recto-intercostal fascial plane block given before incision reduces opioid and inhaled anesthetic use and lowers postoperative pain and nausea in adults having laparoscopic gallbladder removal.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ankara Etlik City Hospital Government |
| Locations | 1 site (Ankara, Türkiye) |
| Trial ID | NCT07502833 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized controlled trial at Etlik City Hospital enrolling adults undergoing elective laparoscopic cholecystectomy. Participants are randomized by closed-envelope to receive either an ultrasound-guided recto-intercostal fascial plane block after induction and intubation but before incision, or standard analgesic management, with anesthesia maintained at about 1 MAC and BIS 40–60. The primary outcome is intraoperative opioid and volatile anesthetic consumption; secondary outcomes include intraoperative hemodynamics, postoperative pain measured by NRS, and incidence of postoperative nausea and vomiting. The block is performed bilaterally under ultrasound guidance by an experienced anesthesiologist, and the protocol follows institutional ethics approval and the Declaration of Helsinki.
Who should consider this trial
Good fit: Adults aged 18–65 scheduled for elective laparoscopic cholecystectomy who are ASA I–III, able to give consent, not pregnant or breastfeeding, weigh at least 75 kg, and have no coagulopathy or local infection are ideal candidates.
Not a fit: Patients with allergy to local anesthetics, coagulopathy or on anticoagulants, infection at the injection site, severe hepatic or renal dysfunction, pregnancy or breastfeeding, or body weight under 75 kg may not benefit or be eligible.
Why it matters
Potential benefit: If effective, the block could reduce intraoperative opioid and inhaled anesthetic needs and lower postoperative pain and nausea for patients.
How similar studies have performed: Other abdominal fascial-plane blocks such as subcostal TAP and rectus sheath blocks have shown reductions in opioid use and postoperative pain, but the recto-intercostal fascial plane block is a newer application with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients aged 18-65 years * Scheduled for elective laparoscopic cholecystectomy * American Society of Anesthesiologists (ASA) physical status I-III * Ability to provide written informed consent Exclusion Criteria: * Refusal to participate * Known allergy to local anesthetics * Coagulopathy or anticoagulant therapy * Infection at the injection site * Body weight less than 75 kg * Severe hepatic or renal dysfunction * Pregnancy or breastfeeding
Where this trial is running
Ankara, Türkiye
- Etlik City Hospital — Ankara, Türkiye, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Oya Kale, specialist anesthesiology
- Email: oyakale@yahoo.com
- Phone: +90 0506 408 21 70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.