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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07745972
- Acronym / sponsor ID
- 2026/153
- Conditions
- Analgesia, Pain Management, Pain, Acute Post-Operative
- Keywords
- Cholesistectomy, Rectointercostal Plane Block, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block | Experimental | Procedure: Rectointercostal facial plane block using bupivacaine 0.25%Recto intercostal Plane Block Group |
| Control | No intervention | –Control Group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI < 35 kg/m²
- Patients with ASA scores I and II
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Block |
Primary outcome
Postoperative opioid consumption
Time frame: 24 hours
Contramal consumption in the first 24 hours after surgery
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Background: PubMed 40485137Tulgar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bora Bilal, Proffesor (+902124446623, bora.bilal@istinye.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07745972, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.