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Not yet recruiting NCT07745972

Ultrasound-Guided Recto-Intercostal Fascial Plane Block in Laparoscopic Cholecystectomy

No phase Interventional Analgesia Pain Management Pain, Acute Post-Operative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rectointercostal facial plane block using bupivacaine 0.25%.
Who it may be relevant to
Registry conditions: Analgesia, Pain Management, Pain, Acute Post-Operative. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of the Effect of Ultrasound-Guided Bilateral Recto-Intercostal Fascial Plane Block on Postoperative Pain, Opioid Consumption, and Quality of Recovery in Laparoscopic Cholecystectomy Surgery: A Prospective, Randomized, Double-Blind Controlled Clinical Study

Overview

The aim of the study is to reduce postoperative pain by performing rectointercostal block in L/S cholecystectomy surgeries. Main goal is to provide well managed post-operative analgesia.

Detailed description

The patients will be divided into two groups and general anesthesia will be applied to all of them. There will be no regional anesthetic technique to be performed, on the other hand, rectointercostal nerve block will be applied to patients in the other group before the patients are extubated. Study randomization is done with computer-generated randomization codes (computer-generated) by a physician who will not participate in patient follow-up. Interfascial plane block (rectointercostal block) will be given to the anesthesiologist in a sealed envelope by an independent assistant staff outside the study, the patient will not know which block is applied. The anesthetist who made the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be performed by another anesthetist blinded to the study.

For the standardization, the block procedure will be performed by an experienced anesthesiologist who has performed at least 20 previous successful and uncomplicated procedures.

Interventions

  • Procedure Rectointercostal facial plane block using bupivacaine 0.25%
    Under ultrasound guidance, a total of 30 mL of solution will be administered bilaterally between the rectus abdominis muscle and the intercostal muscles, at the level of the 6th and 7th costal cartilages bilaterally.

Primary outcome measures

  • Postoperative opioid consumption [Time frame: 24 hours]
Secondary outcome measures (3)
  • NRS Scores [Time frame: At 1,3, 6, 12, 18, 24 hours]
  • Quality of recovery [Time frame: 24 hours]
  • Nausea and vomiting [Time frame: At 1,3, 6, 12, 18, 24 hours]

Eligibility criteria

Inclusion criteria

  • BMI < 35 kg/m²
  • Patients with ASA scores I and II

Exclusion criteria

  • Patients who do not want to be included in the study
  • Psychiatric and neurological disease with blurred consciousness
  • Patients with ASA > 3
  • BMI > 35 kg/m²
  • Abnormality in coagulation parameters
  • History of allergy to local anesthetic drugs
  • Infection at the injection site

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Quadruple blind
Primary purpose
Other

Study locations

Turkey (Türkiye) · 1 center
  • Istinye University Liv Topkapı Hospital — Istanbul

Publications

  • Tulgar S, Ahiskalioglu A, Aydin ME, De Cassai A. Recto-intercostal fascial plane block for upper abdominal analgesia: the ultimate solution? Korean J Anesthesiol. 2025 Oct;78(5):504-505. doi: 10.4097/kja.25355. Epub 2025 Jun 9. No abstract available. PMID 40485137

Identifiers

NCT: NCT07745972 · 2026/153

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗