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Completed

NCT Number: NCT07502833

Recto-intercostal Fascial Plane Block in Cholecystectomy

This study aims to evaluate whether an ultrasound-guided recto-intercostal fascial plane block performed before surgical incision in patients undergoing laparoscopic cholecystectomy reduces intraoperative opioid and volatile anesthetic consumption. Additionally, the study assesses its effects on postoperative pain and the incidence of nausea and vomiting.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Etlik City Hospital

Ankara, Türkiye, 06170, Turkey (Türkiye)

About this study

This prospective, randomized controlled trial is conducted at Etlik City Hospital and includes adult patients undergoing elective laparoscopic cholecystectomy. Institutional Ethics Committee approval is obtained, and the study is conducted in accordance with the Declaration of Helsinki.

Participants are randomly assigned into two groups using a closed-envelope method. All patients receive general anesthesia. After induction and intubation, the block group receives an ultrasound-guided recto-intercostal fascial plane block prior to surgical incision, while the control group receives standard analgesic management. Anesthesia is maintained at approximately 1 minimum alveolar concentration (MAC) with bispectral index (BIS) values between 40 and 60.

The primary outcome is intraoperative opioid and volatile anesthetic consumption. Secondary outcomes include intraoperative hemodynamic parameters, postoperative pain intensity assessed using the Numerical Rating Scale (NRS), and the incidence of postoperative nausea and vomiting (PONV).

The recto-intercostal fascial plane block is performed under ultrasound guidance by an experienced anesthesiologist under aseptic conditions. Local anesthetic is administered bilaterally into the fascial plane between the rectus muscle and the costal cartilage.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Procedure: Recto-intercostal fascial plane block

Procedure

A total of 30 mL of 0.25% bupivacaine is administered bilaterally under ultrasound guidance into the recto-intercostal fascial plane prior to surgical incision.

Primary outcomes

  1. Intraoperative volatile anesthetic consumption

    Time frame: During surgery (up to 3 hours)

    Total intraoperative volatile anesthetic consumption per patient, measured in milliliters (mL).

Secondary outcomes

  1. Intraoperative opioid consumption

    Time frame: During surgery (up to 3 hours)

    Total amount of opioids administered intraoperatively, measured in micrograms (mcg) per patient.

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

Recto-intercostal Fascial Plane Block Reduces Intraoperative Opioid and Volatile Anesthetic Use: a Randomized Trial in Cholecystectomy

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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