Pain ManagementNCT07502833
Recto-intercostal Fascial Plane Block in Cholecystectomy
A study testing Procedure: Recto-intercostal fascial plane block in people with Pain Management and Recto Intercostal Nerve Block, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain Management, Recto Intercostal Nerve Block
- What is being tested?
- Procedure: Recto-intercostal fascial plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2026to 8 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recto-intercostal Fascial Plane Block Reduces Intraoperative Opioid and Volatile Anesthetic Use: a Randomized Trial 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.
Read the detailed description
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.
- Conditions
- Pain Management, Recto Intercostal Nerve Block
- Being tested
- Procedure: Recto-intercostal fascial plane block
- Keywords
- cholecystektomy, rectointercostal facial plane block, opioid consumption, 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.
Procedure: Recto-intercostal fascial plane blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| block group | Active comparator | block group bilateral 30 mlbupivacaine 0.25% Receives: Procedure: Procedure: Recto-intercostal fascial plane block |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative volatile anesthetic consumption
Total intraoperative volatile anesthetic consumption per patient, measured in milliliters (mL).
Measured: During surgery (up to 3 hours)
Secondary outcomes (1)
Intraoperative opioid consumption
Total amount of opioids administered intraoperatively, measured in micrograms (mcg) per patient.
Measured: During surgery (up to 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start3 Jan 2026
- Primary completion7 Jul 2026
- Study completion8 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Oya Kale, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502833
- Sponsor's protocol ID
- AEŞH-EK-2025-246
- Status last verified
- Jul 2026
- First submitted
- 15 Mar 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. All data will be de-identified to protect participant confidentiality and will be accessible only to the study investigators.
Publications
Rehab OM, Bakr DM, El Malla DA, Helal RAEF, Morsy I, Eloraby M. The analgesic effects of ultrasound-guided recto-intercostal fascial plane block in laparoscopic hiatus hernia repair: A randomized double-blind controlled study. Anaesth Crit Care Pain Med. 2026 May;45(3):101724. doi: 10.1016/j.accpm.2025.101724. Epub 2025 Dec 3.
PubMed 41349840Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Alver S, Sakul BU, Ansen G, Pence KB, Alici HA. Recto-intercostal fascial plane block: Another novel fascial plane block. J Clin Anesth. 2023 Oct;89:111163. doi: 10.1016/j.jclinane.2023.111163. Epub 2023 Jun 7. No abstract available.
PubMed 37295124
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recto-intercostal Fascial Plane Block Reduces Intraoperative Opioid and Volatile Anesthetic Use: a Randomized Trial in Cholecystectomy
- ClinicalTrials.gov ID
- NCT07502833
- Acronym / sponsor ID
- AEŞH-EK-2025-246
- Conditions
- Pain Management, Recto Intercostal Nerve Block
- Keywords
- cholecystektomy, rectointercostal facial plane block, opioid consumption, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 3 Jan 2026 (actual)
- Primary completion
- 7 Jul 2026 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 31 Mar 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| block group | Active comparator | Procedure: Procedure: Recto-intercostal fascial plane blockblock group bilateral 30 mlbupivacaine 0.25% |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Refusal to participate
- Known allergy to local anesthetics
- Coagulopathy or anticoagulant therapy
- Infection at the injection site
- Body weight less than 75 kg
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 |
|---|---|---|
| Procedure: Recto-intercostal fascial plane blockA total of 30 mL of 0.25% bupivacaine is administered bilaterally under ultrasound guidance into the recto-intercostal fascial plane prior to surgical incision. | Procedure or surgery | block group |
Primary outcome
Intraoperative volatile anesthetic consumption
Time frame: During surgery (up to 3 hours)
Total intraoperative volatile anesthetic consumption per patient, measured in milliliters (mL).
1 secondary outcome
Intraoperative opioid consumption
Time frame: During surgery (up to 3 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 41349840Rehab OM, Bakr DM, El Malla DA, Helal RAEF, Morsy I, Eloraby M. The analgesic effects of ultrasound-guided recto-intercostal fascial plane block in laparoscopic hiatus hernia repair: A randomized double-blind controlled study. Anaesth Crit Care Pain Med. 2026 May;45(3):101724. doi: 10.1016/j.accpm.2025.101724. Epub 2025 Dec 3.
- Background: PubMed 37295124Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Alver S, Sakul BU, Ansen G, Pence KB, Alici HA. Recto-intercostal fascial plane block: Another novel fascial plane block. J Clin Anesth. 2023 Oct;89:111163. doi: 10.1016/j.jclinane.2023.111163. Epub 2023 Jun 7. No abstract available.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. All data will be de-identified to protect participant confidentiality and will be accessible only to the study investigators.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: Recto-intercostal fascial plane block in people with Pain Management and Recto Intercostal Nerve Block, run by Ankara Etlik City Hospital 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 4 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: finished, as of the sponsor's last update on 22 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative volatile anesthetic consumption (time frame: During surgery (up to 3 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 NCT07502833, which also lists 2 linked publications.
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 22 Jul 2026.