Cholecystectomy, LaparoscopicNCT06976320
Deep Rectus Sheath Block for Laparoscopic Cholecystectomy
A study testing Deep rectus sheath block in people with Cholecystectomy, Laparoscopic and Anesthesia, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain after laparoscopic cholecystectomy can be considerable. Regional techniques such as erector spinae plane (ESP) block or transversus abdominis plane (TAP) block may be suitable for patients at increased risk of postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholecystectomy, Laparoscopic, Anesthesia, Postoperative Pain
- What is being tested?
- Deep rectus sheath block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2025to Jan 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
- Age between 18 and 80 years
- Patients with American Society of Anesthesiology (ASA) physical status I-II
- Patients scheduled for a laparoscopic cholecystectomy
Who cannot join
- Allergy to local anesthetics
- Coagulopathy
- Skin infection at the deep rectus sheath block area
- Advanced hepatic or renal failure
- Chronic pain syndromes
- Alcohol or drug abuse
- Severe pulmonary and/or cardiovascular disease
- Psychiatric disorders
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 Hospital
Istanbul
Taylan Sahin, M.D., +902129794000, taylansah@hotmail.com
Taylan Sahin, M.D.
About this study
Official title: Deep Rectus Sheath Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy
Postoperative pain after laparoscopic cholecystectomy can be considerable. Regional techniques such as erector spinae plane (ESP) block or transversus abdominis plane (TAP) block may be suitable for patients at increased risk of postoperative pain. The deep rectus sheath block is a novel block which is a modified version of the conventional rectus sheath block. It was reported in a few case reports that, it may be used for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. The aim of this study is to investigate the postoperative analgesic efficacy of deep rectus sheath block in patients undergoing laparoscopic cholecystectomy.
Read the detailed description
Patients scheduled for elective laparoscopic gastrectomy will be separated into 2 groups: Control Group and Deep Rectus Sheath Block Group. Patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia. Patients in Deep Rectus Sheath Block Group will be performed Deep Rectus Sheath Block at the end of the surgery, along with patient controlled analgesia with morphine for postoperative analgesia. Morphine consumption for first postoperative 24 hours, numerical rating scale scores, amount of rescue analgesic drug, incidence of postoperative nausea and vomiting will be recorded.
- Being tested
- Intravenous morphine patient control analgesia, Intravenous patient control analgesia, Deep rectus sheath 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.
Intravenous morphine patient control analgesiaOther
24-hour morphine consumption will be recorded
Intravenous patient control analgesiaOther
24-hour morphine consumption will be recorded
Deep rectus sheath blockOther
Deep rectus sheath block will be administered at the end of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia Receives: Other: Intravenous morphine patient control analgesia |
| Deep rectus sheath block group | Active comparator | The patients in deep rectus sheath block group will be received deep rectus sheath block and patient controlled analgesia with morphine for postoperative analgesia Receives: Other: Intravenous patient control analgesia; Other: Deep rectus sheath block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
The amount of morphine required by the patient and given by the device will be recorded for the first 24 hours.
Measured: Postoperative 24 hours
Secondary outcomes (3)
Postoperative numerical rating scale scores
Postoperative pain will be assessed using a numerical rating scale (NRS) (from 0 = no pain to 10 = maximum possible pain) for the first 24 hours.
Measured: Postoperative 24 hours
Rescue analgesic drug requirement
The amount of rescue analgesic in mg required by the patient will be recorded for the first 24 hours.
Measured: Postoperative 24 hours
Incidence of postoperative nausea and vomiting
Number of patients developing postoperative nausea and vomiting will be recorded for the first 24 hours
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start9 Sep 2025
- Primary completionDec 2025 (estimated)
- Study completionJan 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 Cholecystectomy, LaparoscopicStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taylan Sahin, M.D., Principal investigator, Istinye UniversityAli Sait Kavakli, M.D., Principal investigator, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976320
- Sponsor's protocol ID
- Anestezi4
- Status last verified
- Sep 2025
- First submitted
- 9 May 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kavakli AS, Bozkurt MA, Diri M, Sahin T, Koc U, Ipek ZSK, Cekem A. Preperitoneal analgesia under direct visualization: laparoscopic-guided deep rectus sheath block improves postoperative pain control after laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2026 Aug;40(8):6818-6828. doi: 10.1007/s00464-026-12973-5. Epub 2026 Jun 16.
PubMed 42303918
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Rectus Sheath Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06976320
- Acronym / sponsor ID
- Anestezi4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 16 May 2025 (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.
Postoperative pain after laparoscopic cholecystectomy can be considerable. Regional techniques such as erector spinae plane (ESP) block or transversus abdominis plane (TAP) block may be suitable for patients at increased risk of postoperative pain. The deep rectus sheath block is a novel block which is a modified version of the conventional rectus sheath block. It was reported in a few case reports that, it may be used for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. The aim of this study is to investigate the postoperative analgesic efficacy of deep rectus sheath block in patients undergoing laparoscopic cholecystectomy.
Detailed description
Patients scheduled for elective laparoscopic gastrectomy will be separated into 2 groups: Control Group and Deep Rectus Sheath Block Group. Patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia. Patients in Deep Rectus Sheath Block Group will be performed Deep Rectus Sheath Block at the end of the surgery, along with patient controlled analgesia with morphine for postoperative analgesia. Morphine consumption for first postoperative 24 hours, numerical rating scale scores, amount of rescue analgesic drug, incidence of postoperative nausea and vomiting will be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Intravenous morphine patient control analgesiaThe patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia |
| Deep rectus sheath block group | Active comparator | Other: Intravenous patient control analgesia, Other: Deep rectus sheath blockThe patients in deep rectus sheath block group will be received deep rectus sheath block and patient controlled analgesia with morphine for postoperative analgesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 80 years
- Patients with American Society of Anesthesiology (ASA) physical status I-II
- Patients scheduled for a laparoscopic cholecystectomy
Key exclusion criteria (8 listed)
- Allergy to local anesthetics
- Coagulopathy
- Skin infection at the deep rectus sheath block area
- Advanced hepatic or renal failure
- Chronic pain syndromes
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 |
|---|---|---|
| Intravenous morphine patient control analgesia24-hour morphine consumption will be recorded | Other | Control group |
| Intravenous patient control analgesia24-hour morphine consumption will be recorded | Other | Deep rectus sheath block group |
| Deep rectus sheath blockDeep rectus sheath block will be administered at the end of the surgery. | Other | Deep rectus sheath block group |
Primary outcome
Morphine consumption
Time frame: Postoperative 24 hours
The amount of morphine required by the patient and given by the device will be recorded for the first 24 hours.
3 secondary outcomes
Postoperative numerical rating scale scores
Time frame: Postoperative 24 hours
Rescue analgesic drug requirement
Time frame: Postoperative 24 hours
Incidence of postoperative nausea and vomiting
Time frame: Postoperative 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 22 Sep 2025.
- Derived from this study: PubMed 42303918Kavakli AS, Bozkurt MA, Diri M, Sahin T, Koc U, Ipek ZSK, Cekem A. Preperitoneal analgesia under direct visualization: laparoscopic-guided deep rectus sheath block improves postoperative pain control after laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2026 Aug;40(8):6818-6828. doi: 10.1007/s00464-026-12973-5. Epub 2026 Jun 16.
Related trials for Cholecystectomy, Laparoscopic
Active, not recruiting
Effect of Coffee Smelling on Pain, Physiological Parameters and Time to Discharge From Post Anesthesia Care Unit in Patients Undergoing Laparoscopic Cholecystectomy
Cholecystectomy, Laparoscopic
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
Active, not recruiting
Comparison of Intertransverse Process and Erector Spinae Plane Blocks in Acute Postoperative Analgesia Management for Laparoscopic Cholecystectomy Patients
Acut Postoperative Pain, Erector Spinae Plane Block
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
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.
Taylan Sahin, M.D. principal investigator
Istinye University
Ali Sait Kavakli, M.D. principal investigator
Istinye University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep rectus sheath block in people with Cholecystectomy, Laparoscopic and Anesthesia, 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 3 inclusion and 8 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 22 Sep 2025. 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 Taylan Sahin, M.D. (+902129794000, taylansah@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption (time frame: Postoperative 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 NCT06976320, 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 22 Sep 2025.