Laparoscopic CholecystectomyNCT07869316
Subcostal TAP Block Versus Combined Subcostal TAP and Recto-Intercostal Fascial Plane Block for Analgesia After Laparoscopic Cholecystectomy
A study testing Subcostal Transversus Abdominis Plane Block and Recto-Intercostal Fascial Plane Block in people with Laparoscopic Cholecystectomy and Postoperative Pain, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic cholecystectomy is commonly associated with moderate postoperative pain, particularly during the early postoperative period. Inadequate postoperative analgesia may negatively affect patient comfort and recovery, increase opioid consumption, and contribute to opioid-related adverse effects. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Laparoscopic Cholecystectomy, Postoperative Pain
- What is being tested?
- Subcostal Transversus Abdominis Plane Block and 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
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2026to 29 Oct 2027
- 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
- Age between 18 and 80 years
- With a body mass index (BMI) between 18 and 30 kg/m².
- American Society of Anesthesiologists (ASA) physical status I, II, or III
- Scheduled to undergo elective laparoscopic cholecystectomy
Who cannot join
- Age younger than 18 years or older than 80 years
- With a body mass index (BMI) below 18 or above 30 kg/m²
- American Society of Anesthesiologists (ASA) physical status IV or higher
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
Ankara Etlik City Hospital
Ankara, 06170
Elif Şule Özdemir Sezgi, MD, 00905059209638, elifsule-91@hotmail.com
Aslı Dönmez, Professor, 00905322256473, aslidonmez@hotmail.com
About this study
Official title: Comparison of the Postoperative Analgesic Efficacy of Subcostal Transversus Abdominis Plane Block and Combined Subcostal Transversus Abdominis Plane and Recto-Intercostal Fascial Plane Block in Patients Undergoing Elective Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Laparoscopic cholecystectomy is commonly associated with moderate postoperative pain, particularly during the early postoperative period. Inadequate postoperative analgesia may negatively affect patient comfort and recovery, increase opioid consumption, and contribute to opioid-related adverse effects. Therefore, effective multimodal analgesic strategies are of considerable importance in patients undergoing laparoscopic cholecystectomy.
Subcostal transversus abdominis plane (TAP) block is a regional anesthesia technique used to provide analgesia for upper abdominal surgery. However, its analgesic coverage may be insufficient in some patients because of the complex innervation of the upper abdominal wall. The recto-intercostal fascial plane block has been described as a fascial plane block targeting the anterior branches of the thoracoabdominal nerves and may provide additional analgesic benefit when combined with subcostal TAP block.
This study aims to compare the postoperative analgesic efficacy of bilateral subcostal TAP block alone with that of bilateral subcostal TAP block combined with recto-intercostal fascial plane block in patients undergoing elective laparoscopic cholecystectomy.
- Conditions
- Laparoscopic Cholecystectomy, Postoperative Pain
- Being tested
- Subcostal Transversus Abdominis Plane Block, Recto-Intercostal Fascial Plane Block
- Keywords
- Laparoscopic cholecystectomy, Transversus abdominis plane block, Recto-intercostal fascial plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcostal Transversus Abdominis Plane BlockProcedure or surgery
Following induction of general anesthesia and before surgical incision, a bilateral ultrasound-guided subcostal transversus abdominis plane block will be performed using a total volume of 40 mL of 0.20% bupivacaine.
Recto-Intercostal Fascial Plane BlockProcedure or surgery
Following induction of general anesthesia and before surgical incision, a bilateral ultrasound-guided recto-intercostal fascial plane block will be performed using a total volume of 30 mL of 0.20% bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Subcostal Transversus Abdominis Plane Block | Active comparator | Following induction of general anesthesia and before surgical incision, participants will receive a bilateral ultrasound-guided subcostal transversus abdominis plane block using a total volume of 40 mL of 0.20% bupivacaine. Receives: Procedure: Subcostal Transversus Abdominis Plane Block |
| Subcostal Transversus Abdominis Plane Block + Recto-Intercostal Fascial Plane Block | Active comparator | Following induction of general anesthesia and before surgical incision, participants will receive a bilateral ultrasound-guided subcostal transversus abdominis plane block using a total volume of 40 mL of 0.20% bupivacaine together with a bilateral ultrasound-guided recto-intercostal fascial plane block using a total volume of 30 mL of 0.20% bupivacaine. Receives: Procedure: Subcostal Transversus Abdominis Plane Block; Procedure: Recto-Intercostal Fascial Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Pain will be assessed at rest using the visual analog scale on a scale from 0 (no pain) to 100 (worst pain). Pain assessment will be done at 6th hour after surgery.
Measured: At 6 hours after surgery.
Secondary outcomes (2)
Pain Scores
Pain will be assessed at rest using the visual analog scale on a scale from 0 (no pain) to 100 (worst pain). Pain assessment will be done at 0st, 1st, 2nd, 12th, and 24th hours after surgery.
Measured: At 0, 1, 2, 12, and 24 hours after surgery.
Total Postoperative Opioid Consumption During the First 24 Hours After Surgery
Total Postoperative Opioid Consumption During the First 24 Hours After Surgery
Measured: During the first 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start14 Oct 2026 (estimated)
- Primary completion15 Oct 2027 (estimated)
- Study completion29 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elif Sule Ozdemir, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869316
- Sponsor's protocol ID
- AEŞH-EK-2026-209
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Postoperative Analgesic Efficacy of Subcostal Transversus Abdominis Plane Block and Combined Subcostal Transversus Abdominis Plane and Recto-Intercostal Fascial Plane Block in Patients Undergoing Elective Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07869316
- Acronym / sponsor ID
- AEŞH-EK-2026-209
- Conditions
- Laparoscopic Cholecystectomy, Postoperative Pain
- Keywords
- Laparoscopic cholecystectomy, Transversus abdominis plane block, Recto-intercostal fascial plane block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 14 Oct 2026 (estimated)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 29 Oct 2027 (estimated)
- First posted
- 9 Oct 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.
Laparoscopic cholecystectomy is commonly associated with moderate postoperative pain, particularly during the early postoperative period. Inadequate postoperative analgesia may negatively affect patient comfort and recovery, increase opioid consumption, and contribute to opioid-related adverse effects. Therefore, effective multimodal analgesic strategies are of considerable importance in patients undergoing laparoscopic cholecystectomy.
Subcostal transversus abdominis plane (TAP) block is a regional anesthesia technique used to provide analgesia for upper abdominal surgery. However, its analgesic coverage may be insufficient in some patients because of the complex innervation of the upper abdominal wall. The recto-intercostal fascial plane block has been described as a fascial plane block targeting the anterior branches of the thoracoabdominal nerves and may provide additional analgesic benefit when combined with subcostal TAP block.
This study aims to compare the postoperative analgesic efficacy of bilateral subcostal TAP block alone with that of bilateral subcostal TAP block combined with recto-intercostal fascial plane block in patients undergoing elective laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcostal Transversus Abdominis Plane Block | Active comparator | Procedure: Subcostal Transversus Abdominis Plane BlockFollowing induction of general anesthesia and before surgical incision, participants will receive a bilateral ultrasound-guided subcostal transversus abdominis plane block using a total volume of 40 mL of 0.20% bupivacaine. |
| Subcostal Transversus Abdominis Plane Block + Recto-Intercostal Fascial Plane Block | Active comparator | Procedure: Subcostal Transversus Abdominis Plane Block, Procedure: Recto-Intercostal Fascial Plane BlockFollowing induction of general anesthesia and before surgical incision, participants will receive a bilateral ultrasound-guided subcostal transversus abdominis plane block using a total volume of 40 mL of 0.20% bupivacaine together with a bilateral ultrasound-guided recto-intercostal fascial plane block using a total volume of 30 mL of 0.20% bupivacaine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 80 years
- With a body mass index (BMI) between 18 and 30 kg/m².
- American Society of Anesthesiologists (ASA) physical status I, II, or III
- Scheduled to undergo elective laparoscopic cholecystectomy
Key exclusion criteria (3 listed)
- Age younger than 18 years or older than 80 years
- With a body mass index (BMI) below 18 or above 30 kg/m²
- American Society of Anesthesiologists (ASA) physical status IV or higher
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 |
|---|---|---|
| Subcostal Transversus Abdominis Plane BlockFollowing induction of general anesthesia and before surgical incision, a bilateral ultrasound-guided subcostal transversus abdominis plane block will be performed using a total volume of 40 mL of 0.20% bupivacaine. | Procedure or surgery | Subcostal Transversus Abdominis Plane Block, Subcostal Transversus Abdominis Plane Block + Recto-Intercostal Fascial Plane Block |
| Recto-Intercostal Fascial Plane BlockFollowing induction of general anesthesia and before surgical incision, a bilateral ultrasound-guided recto-intercostal fascial plane block will be performed using a total volume of 30 mL of 0.20% bupivacaine. | Procedure or surgery | Subcostal Transversus Abdominis Plane Block + Recto-Intercostal Fascial Plane Block |
Primary outcome
Pain Score
Time frame: At 6 hours after surgery.
Pain will be assessed at rest using the visual analog scale on a scale from 0 (no pain) to 100 (worst pain). Pain assessment will be done at 6th hour after surgery.
2 secondary outcomes
Pain Scores
Time frame: At 0, 1, 2, 12, and 24 hours after surgery.
Total Postoperative Opioid Consumption During the First 24 Hours After Surgery
Time frame: During the first 24 hours after surgery.
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 16 Oct 2026.
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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 Subcostal Transversus Abdominis Plane Block and Recto-Intercostal Fascial Plane Block in people with Laparoscopic Cholecystectomy and Postoperative Pain, run by Diskapi Yildirim Beyazit Education and Research 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 3 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: opening soon, as of the sponsor's last update on 16 Oct 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 Elif Şule Özdemir Sezgi (00905059209638, elifsule-91@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: At 6 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.