Peripheral Nerve BlockNCT07061262
External Oblique Plane Block and Subcostal Tap Block for Laparoscopic Cholecystectomy
A study testing External Oblique Intercostal Plane Block and Subcostal TAP block and spinal anesthesia group (STAP) in people with Peripheral Nerve Block and Cholecystectomy, Laparoscopic, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The study aims to compare the efficacy of the external oblique plane block and the subcostal plane block in providing pain relief during perioperative anaesthetic management. As intraoperative haemodynamic stability is an important factor for surgeons to achieve better outcomes due to its effect on the quality of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Nerve Block, Cholecystectomy, Laparoscopic, Pain After Surgery
- What is being tested?
- External Oblique Intercostal Plane Block and Subcostal TAP block and spinal anesthesia group (STAP)
- 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
- 1 Jan 2024to 13 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anaesthesiologists (ASA) Physical Status classification I to III
- Patients who will give informed consent to peripheral nerve blocks
Who cannot join
- Refusal to participate in the study
- History of neurologic deficits or neuropathy
- Infection at the site of the block application
- Coagulopathy
- bleeding disorders
- Allergy to local anaesthetics
Show all 9Show fewer
- Uncooperative patients who cannot reliably respond to verbal pain evaluation
- Kidney Failure
- Liver Failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul
About this study
Official title: The Comparison of Postoperative Analgesic Efficacy Between External Oblique Plane Block and Subcostal Tap Block in Patients Undergoing Laparoscopic Cholecystectomy
The study aims to compare the efficacy of the external oblique plane block and the subcostal plane block in providing pain relief during perioperative anaesthetic management. As intraoperative haemodynamic stability is an important factor for surgeons to achieve better outcomes due to its effect on the quality of laparoscopic intervention, the investigator will observe its impact on this matter.
Ninety patients scheduled for elective surgery will be randomly assigned by a closed-envelope method into three groups (n = 30) receiving either a subcostal plan block, an external oblique plane block, or a control block preoperatively. Each group receive standardised general anaesthesia and perioperative pain management protocol. The data to be recorded include a numeric rating scale, intraoperative and postoperative analgesic use, intraoperative haemodynamic parameters, and VAS score. Moreover, block performance time, motor block and side effects or complications will be noted.
Read the detailed description
All patients will receive standard general anaesthesia under standard monitorization; induction with 0,1-0,4 mg/kg midazolam, 2-2,5 mg/kg propofol, 1-2 mcq/kg fentanyl, 0,6-1,0 mg /kg rocuronium followed by 2% MAC sevoflurane in an air-oxygen mixture for maintenance of anaesthesia. Randomization is designed with concealed opaque envelope in a 1:1 ratio into two block groups (n= 30): subcostal plane block (Group A) and external oblique plane block (Group B) and control group ( Group C ). All blocks will be performed before surgical incision by a single experienced regional anaesthesiologist (A.A.) under ultrasound guidance with same local anaesthetic doses: 0.25% bupivacaine anaesthetic solution of 20 ml. The anaesthesia technician will record the duration of the block procedure. Then the investigator will apply dexamethasone 8 mg (IV), NSAIDs and after the patient will be ready for surgical incision. Intraoperative haemodynamic values (heart rate, systolic and mean arterial pressure) will be recorded by the same technician. The same analgesia protocol will be applied, consisting of an infusion of remifentanil (0.01 to 0.1 μg · kg-1 · min-1) if only needed to maintain heart rate and mean blood pressure within 20% of pre-induction values, and 1 g of paracetamol. Pain will be evaluated using both a numeric rating scale (0-10) and a verbal rating scale, starting at the post-anaesthesia care unit (PACU) and at time intervals of 2, 6, 12, and 24 hours postoperatively. Patients with persistent pain scores of higher than 4 out of 10 will receive rescue analgesia with 1mg/kg (maximum daily dose, 4x1) tramadol and 1 g (maximum daily dose, 4x1) paracetamol.
- Being tested
- External Oblique Intercostal Plane Block, Subcostal TAP block and spinal anesthesia group (STAP)
- Keywords
- Laparoscopic cholecystectomy, postoperative pain, subcostal plane block, external oblique intercostal 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.
External Oblique Intercostal Plane BlockProcedure or surgery
Right after general anaesthesia induction and patient intubation, the patient will be placed in a supine position. Following sterile skin preparation, an external oblique plane block will be performed by the same anesthesiologist under ultrasound guidance, using an external oblique muscle approach. A 22-gauge, 50-mm insulated stimulating needle will be used to administer 20 mL of anaesthetic solution (0.25% bupivacaine, 20 mL). Finally, 20 mL of local anaesthetic solution (0.25% bupivacaine anaesthetic solution) will be administered to disperse within the external oblique space.
Subcostal TAP block and spinal anesthesia group (STAP)Procedure or surgery
Right after general anaesthesia induction and patient intubation, the patient will be placed in a supine position. Following sterile skin preparation, a subcostal block will be performed by the same anaesthesiologist under ultrasound guidance with a subcostal approach. A 22-gauge, 50-mm insulated stimulating needle will be used to administer 20 mL of anaesthetic solution (0.25% bupivacaine, 20 mL). Finally, 20 mL of local anaesthetic solution (0.25% bupivacaine anaesthetic solution) will be administered to disperse within the subcostal space.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No peripheral nerve block |
| External Oblique Plane Block | Experimental | Right after general anaesthesia induction and patient intubation, the patient will be placed in a supine position. Following sterile skin preparation, an external oblique plane block will be performed by the same anaesthesiologist under ultrasound guidance, using an external oblique muscle approach, in addition to standard analgesia applied in the control group. Receives: Procedure: External Oblique Intercostal Plane Block |
| Subcostal Plane Block | Active comparator | Right after general anaesthesia induction and patient intubation, the patient will be placed in a supine position. Following sterile skin preparation, a subcostal block will be performed by the same anaesthesiologist under ultrasound guidance with subcostal approach, in addition to standard analgesia applied in the control group. Receives: Procedure: Subcostal TAP block and spinal anesthesia group (STAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Numeric rating scale (NRS) worst pain imaginable as 10 points to zero for no pain.
Measured: postoperative day 1
Secondary outcomes (1)
The total amount of analgesic drugs used
The total amount of analgesic drugs used during the postoperative follow-up
Measured: postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Jan 2024
- Primary completion28 Dec 2024
- Study completion13 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral Nerve BlockStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berna Caliskan, Study director, Haseki Training and Research Hospital: Istanbul Haseki Egitim Ve Arastirma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061262
- Sponsor's protocol ID
- 266-2023
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kar S, Agrawal H, Yelamanchi R, Jain A, Kumar A, Agarwal N, Gupta N. Laparoscopy-guided transverse abdominis plane block versus port site infiltration for post-operative pain relief after laparoscopic cholecystectomy. J Minim Access Surg. 2025 Apr 1;21(2):126-132. doi: 10.4103/jmas.jmas_242_23. Epub 2024 Jul 30.
PubMed 39095984Qi-Hong S, Xu-Yan Z, Xu S, Yan-Jun C, Ke L, Rong W. Comparison of Ultrasound-Guided Erector Spinae Plane Block and Oblique Subcostal Transverse Abdominis Plane Block for Postoperative Analgesia in Elderly Patients After Laparoscopic Colorectal Surgery: A Prospective Randomized Study. Pain Ther. 2021 Dec;10(2):1709-1718. doi: 10.1007/s40122-021-00329-x. Epub 2021 Oct 15.
PubMed 34652717Gangadhar V, Gupta A, Saini S. Comparison of analgesic efficacy of combined external oblique intercostal and rectus sheath block with local infiltration analgesia at port site in patients undergoing laparoscopic cholecystectomy: a randomized controlled trial. Anesth Pain Med (Seoul). 2024 Jul;19(3):247-255. doi: 10.17085/apm.24002. Epub 2024 Jul 31.
PubMed 39118335
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Postoperative Analgesic Efficacy Between External Oblique Plane Block and Subcostal Tap Block in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07061262
- Acronym / sponsor ID
- 266-2023
- Keywords
- Laparoscopic cholecystectomy, postoperative pain, subcostal plane block, external oblique intercostal plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 28 Dec 2024 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 11 Jul 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.
The study aims to compare the efficacy of the external oblique plane block and the subcostal plane block in providing pain relief during perioperative anaesthetic management. As intraoperative haemodynamic stability is an important factor for surgeons to achieve better outcomes due to its effect on the quality of laparoscopic intervention, the investigator will observe its impact on this matter.
Ninety patients scheduled for elective surgery will be randomly assigned by a closed-envelope method into three groups (n = 30) receiving either a subcostal plan block, an external oblique plane block, or a control block preoperatively. Each group receive standardised general anaesthesia and perioperative pain management protocol. The data to be recorded include a numeric rating scale, intraoperative and postoperative analgesic use, intraoperative haemodynamic parameters, and VAS score. Moreover, block performance time, motor block and side effects or complications will be noted.
Detailed description
All patients will receive standard general anaesthesia under standard monitorization; induction with 0,1-0,4 mg/kg midazolam, 2-2,5 mg/kg propofol, 1-2 mcq/kg fentanyl, 0,6-1,0 mg /kg rocuronium followed by 2% MAC sevoflurane in an air-oxygen mixture for maintenance of anaesthesia. Randomization is designed with concealed opaque envelope in a 1:1 ratio into two block groups (n= 30): subcostal plane block (Group A) and external oblique plane block (Group B) and control group ( Group C ). All blocks will be performed before surgical incision by a single experienced regional anaesthesiologist (A.A.) under ultrasound guidance with same local anaesthetic doses: 0.25% bupivacaine anaesthetic solution of 20 ml. The anaesthesia technician will record the duration of the block procedure. Then the investigator will apply dexamethasone 8 mg (IV), NSAIDs and after the patient will be ready for surgical incision. Intraoperative haemodynamic values (heart rate, systolic and mean arterial pressure) will be recorded by the same technician. The same analgesia protocol will be applied, consisting of an infusion of remifentanil (0.01 to 0.1 μg · kg-1 · min-1) if only needed to maintain heart rate and mean blood pressure within 20% of pre-induction values, and 1 g of paracetamol. Pain will be evaluated using both a numeric rating scale (0-10) and a verbal rating scale, starting at the post-anaesthesia care unit (PACU) and at time intervals of 2, 6, 12, and 24 hours postoperatively. Patients with persistent pain scores of higher than 4 out of 10 will receive rescue analgesia with 1mg/kg (maximum daily dose, 4x1) tramadol and 1 g (maximum daily dose, 4x1) paracetamol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No peripheral nerve block |
| External Oblique Plane Block | Experimental | Procedure: External Oblique Intercostal Plane BlockRight after general anaesthesia induction and patient intubation, the patient will be placed in a supine position. Following sterile skin preparation, an external oblique plane block will be performed by the same anaesthesiologist under ultrasound guidance, using an external oblique muscle approach, in addition to standard analgesia applied in the control group. |
| Subcostal Plane Block | Active comparator | Procedure: Subcostal TAP block and spinal anesthesia group (STAP)Right after general anaesthesia induction and patient intubation, the patient will be placed in a supine position. Following sterile skin preparation, a subcostal block will be performed by the same anaesthesiologist under ultrasound guidance with subcostal approach, in addition to standard analgesia applied in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anaesthesiologists (ASA) Physical Status classification I to III
Key exclusion criteria (9 listed)
- Refusal to participate in the study
- History of neurologic deficits or neuropathy
- Infection at the site of the block application
- Coagulopathy
- bleeding disorders
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 |
|---|---|---|
| External Oblique Intercostal Plane BlockRight after general anaesthesia induction and patient intubation, the patient will be placed in a supine position. Following sterile skin preparation, an external oblique plane block will be performed by the same anesthesiologist under ultrasound guidance, using an external oblique muscle approach. A 22-gauge, 50-mm insulated stimulating needle will be used to administer 20 mL of anaesthetic solution (0.25% bupivacaine, 20 mL). Finally, 20 mL of local anaesthetic solution (0.25% bupivacaine anaesthetic solution) will be administered to disperse within the external oblique space. | Procedure or surgery | External Oblique Plane Block |
| Subcostal TAP block and spinal anesthesia group (STAP)Right after general anaesthesia induction and patient intubation, the patient will be placed in a supine position. Following sterile skin preparation, a subcostal block will be performed by the same anaesthesiologist under ultrasound guidance with a subcostal approach. A 22-gauge, 50-mm insulated stimulating needle will be used to administer 20 mL of anaesthetic solution (0.25% bupivacaine, 20 mL). Finally, 20 mL of local anaesthetic solution (0.25% bupivacaine anaesthetic solution) will be administered to disperse within the subcostal space. | Procedure or surgery | Subcostal Plane Block |
Primary outcome
Pain Score
Time frame: postoperative day 1
Numeric rating scale (NRS) worst pain imaginable as 10 points to zero for no pain.
1 secondary outcome
The total amount of analgesic drugs used
Time frame: postoperative day 1
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 11 Jul 2025.
- Background: PubMed 39095984Kar S, Agrawal H, Yelamanchi R, Jain A, Kumar A, Agarwal N, Gupta N. Laparoscopy-guided transverse abdominis plane block versus port site infiltration for post-operative pain relief after laparoscopic cholecystectomy. J Minim Access Surg. 2025 Apr 1;21(2):126-132. doi: 10.4103/jmas.jmas_242_23. Epub 2024 Jul 30.
- Background: PubMed 34652717Qi-Hong S, Xu-Yan Z, Xu S, Yan-Jun C, Ke L, Rong W. Comparison of Ultrasound-Guided Erector Spinae Plane Block and Oblique Subcostal Transverse Abdominis Plane Block for Postoperative Analgesia in Elderly Patients After Laparoscopic Colorectal Surgery: A Prospective Randomized Study. Pain Ther. 2021 Dec;10(2):1709-1718. doi: 10.1007/s40122-021-00329-x. Epub 2021 Oct 15.
- Background: PubMed 39118335Gangadhar V, Gupta A, Saini S. Comparison of analgesic efficacy of combined external oblique intercostal and rectus sheath block with local infiltration analgesia at port site in patients undergoing laparoscopic cholecystectomy: a randomized controlled trial. Anesth Pain Med (Seoul). 2024 Jul;19(3):247-255. doi: 10.17085/apm.24002. Epub 2024 Jul 31.
- 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. This study is not recruiting at the moment.
Berna Caliskan study director
Haseki Training and Research Hospital: Istanbul Haseki Egitim Ve Arastirma Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Oblique Intercostal Plane Block and Subcostal TAP block and spinal anesthesia group (STAP) in people with Peripheral Nerve Block and Cholecystectomy, Laparoscopic, run by Haseki Training 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 2 inclusion and 9 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 11 Jul 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?
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?
Pain Score (time frame: postoperative day 1). 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 NCT07061262, which also lists 3 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 11 Jul 2025.