AnalgesiaNCT07745972
Ultrasound-Guided Recto-Intercostal Fascial Plane Block in Laparoscopic Cholecystectomy
A study testing Rectointercostal facial plane block using bupivacaine 0.25% in people with Analgesia and Pain Management, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia, Pain Management, Pain, Acute Post-Operative
- What is being tested?
- Rectointercostal facial plane block using bupivacaine 0.25%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Aug 2026to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI < 35 kg/m²
- Patients with ASA scores I and II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istinye University Liv Topkapı Hospital
Istanbul, 34050
About this study
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
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.
Read the 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.
- Conditions
- Analgesia, Pain Management, Pain, Acute Post-Operative
- Being tested
- Rectointercostal facial plane block using bupivacaine 0.25%
- Keywords
- Cholesistectomy, Rectointercostal Plane Block, Postoperative Pain
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectointercostal facial plane block using bupivacaine 0.25%Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Block | Experimental | Recto intercostal Plane Block Group Receives: Procedure: Rectointercostal facial plane block using bupivacaine 0.25% |
| Control | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
Contramal consumption in the first 24 hours after surgery
Measured: 24 hours
Secondary outcomes (3)
NRS Scores
NRS scores in the first 24 hours after surgery
Measured: At 1,3, 6, 12, 18, 24 hours
Quality of recovery
QR15 scores
Measured: 24 hours
Nausea and vomiting
Nausea and vomiting scores in the first 24 hours
Measured: At 1,3, 6, 12, 18, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start6 Aug 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bora Bilal, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745972
- Sponsor's protocol ID
- 2026/153
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40485137