Laparoskopic CholecystectomyNCT06932835
Comparison of Postoperative Analgesic Efficacy of Transversus Abdominis Plane Block (TAP) and Modified Thoracoabdominal Nerve Block (M-TAPA)
A study testing Transversus Abdominis Plane (TAP) Block and Modified Thoracoabdominal Nerve Block (M-TAPA) in people with Laparoskopic Cholecystectomy and Transversus Abdominis Plane (TAP) Block, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic cholecystectomy is a frequently performed surgical procedure and is considered the gold standard for treating symptomatic gallstone disease. Although laparoscopic cholecystectomy is considered minimally invasive, it can cause moderate to severe pain in the postoperative period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoskopic Cholecystectomy, Transversus Abdominis Plane (TAP) Block, Modified Thoracoabdominal Nerve Block (M-TAPA)
- What is being tested?
- Transversus Abdominis Plane (TAP) Block and Modified Thoracoabdominal Nerve Block (M-TAPA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2025to 21 Apr 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years old
- American Society of Anesthesiologists (ASA) physical status I-II-III
- Body mass index 18 to 30 kg/m2
- Elective laparoscopic cholecystectomy surgery
Who cannot join
- Under 18 and over 65
- ASA score IV and above
- Advanced co-morbidity
- History of bleeding diathesis
- Patient refusing the procedure
- Chronic opioid or analgesic use
Show all 10Show fewer
- Patients who will operate under emergency conditions
- Block injection site infection
- Known allergy to local anesthetics
- Pregnancy
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
Ankara Etlik City Hospital
Yenimahalle, Ankara, 06170
MÜRÜVVET TAŞKIR TURAN, MD, 00905065536934, taskirmuruvvet@gmail.com
MUSA ZENGİN, Associate Professor, 00905307716235, musazengin@gmail.com
About this study
Official title: Comparison of Postoperative Analgesic Efficacy of Transversus Abdominis Plane Block (TAP) and Modified Thoracoabdominal Nerve Block (M-TAPA) in Patients Undergoing Laparoscopic Cholecystectomy
Laparoscopic cholecystectomy is a frequently performed surgical procedure and is considered the gold standard for treating symptomatic gallstone disease. Although laparoscopic cholecystectomy is considered minimally invasive, it can cause moderate to severe pain in the postoperative period. Poorly controlled early postoperative pain can impair recovery quality and increase the risk of postoperative pulmonary complications as a risk factor for chronic pain development. Multimodal analgesia, including opioids, is used to limit pain following laparoscopic cholecystectomy. However, opioid treatment may lead to side effects such as postoperative nausea and vomiting (PONV), respiratory depression, and constipation.
Nerve blocks provide better pain control, reduce opioid consumption in the postoperative period, and offer advantages such as fewer side effects and a lower risk of pulmonary and cardiac complications.
Read more
In our clinic, a multimodal analgesia approach is preferred for patients undergoing laparoscopic cholecystectomy. In addition to intravenous analgesic agents, peripheral nerve blocks are administered based on patient preference (for all eligible and consenting patients).
This study aims to compare the postoperative analgesic efficacy of the Transversus Abdominis Plane (TAP) Block and the Modified Thoracoabdominal Nerve Block with a Pericostal Approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy. Standard analgesic methods are applied to patients who do not consent to peripheral nerve block administration.
- Conditions
- Laparoskopic Cholecystectomy, Transversus Abdominis Plane (TAP) Block, Modified Thoracoabdominal Nerve Block (M-TAPA)
- Being tested
- Transversus Abdominis Plane (TAP) Block, Modified Thoracoabdominal Nerve Block (M-TAPA)
- Keywords
- remifantanile conception, acute pain, Postoperatif pain
- Medical subject headings
- Bites and Stings, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus Abdominis Plane (TAP) BlockDrug
Transversus Abdominis Plane (TAP) Block is performed under ultrasound guidance before the surgical procedure and anesthesia induction, with the patient in the supine position.
Modified Thoracoabdominal Nerve Block (M-TAPA)Drug
Modified Thoracoabdominal Nerve Block (M-TAPA) is performed under ultrasound guidance before the surgical procedure and anesthesia induction, with the patient in the supine position.
| Study group | Role | What they receive |
|---|---|---|
| Transversus Abdominis Plane (TAP) Block | Active comparator | The patient is placed in the supine position,the injection site is disinfected.The Transversus Abdominis Plane block is performed under ultrasound guidance using a high-frequency linear probe(6-13 MHz)placed sagittally at the midpoint between the costal margin and the iliac crest.On ultrasound, the skin, subcutaneous fat tissue, external oblique muscle, internal oblique muscle, and transversus abdominis muscle are visualized. A 2G, 80 mm block needle is inserted in the same plane as the ultrasound probe.As the needle passes through the muscle layers and fascial planes, a fascial "click" sensation is felt, and the needle tip is advanced under ultrasound guidance in a controlled manner.After the second "click" sensation(the passage through the internal oblique muscle fascia) a test dose of 1 mL is administered to confirm needle tip localization.Once the location is verified, 20 mL of 0.25% bupivacaine is injected into the neurofascial plane. then repeated on the contralateral side. Receives: Drug: Transversus Abdominis Plane (TAP) Block |
| Modified Thoracoabdominal Nerve Block (M-TAPA) | Active comparator | The patient is placed in the supine position, and the injection site is disinfected.Modified Thoracoabdominal Nerve Block To identify the transversus abdominis, internal oblique and external oblique muscles a high-frequency linear ultrasound probe (6-13 MHz) is placed sagittally at the 10th costal margin under USG guidance.After positioning the probe sagittally at the 10th costal margin in the midline, it is angled deeply toward the costochondral angle to visualize the lower costal cartilage.Using an in-plane technique, a 22G, 80 mm block needle is inserted in a cranial direction between the transversus abdominis muscle and the lower surface of the costal cartilage. The needle tip is advanced toward the posterior surface of the 10th costal cartilage, and 20 mL of 0.25% bupivacaine is injected beneath the chondrium while ensuring that the needle tip does not pass beyond the cranial border of the 10th costal cartilage. The same procedure is then repeated on the contralateral side. Receives: Drug: Modified Thoracoabdominal Nerve Block (M-TAPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Pain will be assessed at rest and while movement using the from 0 (no pain) to 10 (worst
Measured: First 24 hours after surgery
Secondary outcomes (1)
Intraoperative remifentanil consumption
The amount of remifentanil that patients need to maintain anesthesia during the intraoperative period will be recorded
Measured: During The intraoperatif period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start2 Jun 2025
- Primary completion11 Apr 2026 (estimated)
- Study completion21 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoskopic CholecystectomyStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muruvvet Taskir Turan, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932835
- Sponsor's protocol ID
- AEŞH-EK-2025-043
- Status last verified
- Jun 2025
- First submitted
- 10 Apr 2025
- Last updated
- 4 Jun 2025
- 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 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Efficacy of Transversus Abdominis Plane Block (TAP) and Modified Thoracoabdominal Nerve Block (M-TAPA) in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06932835
- Acronym / sponsor ID
- AEŞH-EK-2025-043
- Conditions
- Laparoskopic Cholecystectomy, Transversus Abdominis Plane (TAP) Block, Modified Thoracoabdominal Nerve Block (M-TAPA)
- Keywords
- remifantanile conception, acute pain, Postoperatif pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 11 Apr 2026 (estimated)
- Study completion
- 21 Apr 2026 (estimated)
- First posted
- 17 Apr 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.
Laparoscopic cholecystectomy is a frequently performed surgical procedure and is considered the gold standard for treating symptomatic gallstone disease. Although laparoscopic cholecystectomy is considered minimally invasive, it can cause moderate to severe pain in the postoperative period. Poorly controlled early postoperative pain can impair recovery quality and increase the risk of postoperative pulmonary complications as a risk factor for chronic pain development. Multimodal analgesia, including opioids, is used to limit pain following laparoscopic cholecystectomy. However, opioid treatment may lead to side effects such as postoperative nausea and vomiting (PONV), respiratory depression, and constipation.
Nerve blocks provide better pain control, reduce opioid consumption in the postoperative period, and offer advantages such as fewer side effects and a lower risk of pulmonary and cardiac complications.
In our clinic, a multimodal analgesia approach is preferred for patients undergoing laparoscopic cholecystectomy. In addition to intravenous analgesic agents, peripheral nerve blocks are administered based on patient preference (for all eligible and consenting patients).
This study aims to compare the postoperative analgesic efficacy of the Transversus Abdominis Plane (TAP) Block and the Modified Thoracoabdominal Nerve Block with a Pericostal Approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy. Standard analgesic methods are applied to patients who do not consent to peripheral nerve block administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversus Abdominis Plane (TAP) Block | Active comparator | Drug: Transversus Abdominis Plane (TAP) BlockThe patient is placed in the supine position,the injection site is disinfected.The Transversus Abdominis Plane block is performed under ultrasound guidance using a high-frequency linear probe(6-13 MHz)placed sagittally at the midpoint between the costal margin and the iliac crest.On ultrasound, the skin, subcutaneous fat tissue, external oblique muscle, internal oblique muscle, and transversus abdominis muscle are visualized. A 2G, 80 mm block needle is inserted in the same plane as the ultrasound probe.As the needle passes through the muscle layers and fascial planes, a fascial "click" sensation is felt, and the needle tip is advanced under ultrasound guidance in a controlled manner.After the second "click" sensation(the passage through the internal oblique muscle fascia) a test dose of 1 mL is administered to confirm needle tip localization.Once the location is verified, 20 mL of 0.25% bupivacaine is injected into the neurofascial plane. then repeated on the contralateral side. |
| Modified Thoracoabdominal Nerve Block (M-TAPA) | Active comparator | Drug: Modified Thoracoabdominal Nerve Block (M-TAPA)The patient is placed in the supine position, and the injection site is disinfected.Modified Thoracoabdominal Nerve Block To identify the transversus abdominis, internal oblique and external oblique muscles a high-frequency linear ultrasound probe (6-13 MHz) is placed sagittally at the 10th costal margin under USG guidance.After positioning the probe sagittally at the 10th costal margin in the midline, it is angled deeply toward the costochondral angle to visualize the lower costal cartilage.Using an in-plane technique, a 22G, 80 mm block needle is inserted in a cranial direction between the transversus abdominis muscle and the lower surface of the costal cartilage. The needle tip is advanced toward the posterior surface of the 10th costal cartilage, and 20 mL of 0.25% bupivacaine is injected beneath the chondrium while ensuring that the needle tip does not pass beyond the cranial border of the 10th costal cartilage. The same procedure is then repeated on the contralateral side. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 65 years old
- American Society of Anesthesiologists (ASA) physical status I-II-III
- Body mass index 18 to 30 kg/m2
- Elective laparoscopic cholecystectomy surgery
Key exclusion criteria (10 listed)
- Under 18 and over 65
- ASA score IV and above
- Advanced co-morbidity
- History of bleeding diathesis
- Patient refusing the procedure
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 |
|---|---|---|
| Transversus Abdominis Plane (TAP) BlockTransversus Abdominis Plane (TAP) Block is performed under ultrasound guidance before the surgical procedure and anesthesia induction, with the patient in the supine position. | Drug | Transversus Abdominis Plane (TAP) Block |
| Modified Thoracoabdominal Nerve Block (M-TAPA)Modified Thoracoabdominal Nerve Block (M-TAPA) is performed under ultrasound guidance before the surgical procedure and anesthesia induction, with the patient in the supine position. | Drug | Modified Thoracoabdominal Nerve Block (M-TAPA) |
Primary outcome
Pain scores
Time frame: First 24 hours after surgery
Pain will be assessed at rest and while movement using the from 0 (no pain) to 10 (worst
1 secondary outcome
Intraoperative remifentanil consumption
Time frame: During The intraoperatif period
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 4 Jun 2025.
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 Transversus Abdominis Plane (TAP) Block and Modified Thoracoabdominal Nerve Block (M-TAPA) in people with Laparoskopic Cholecystectomy and Transversus Abdominis Plane (TAP) 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 10 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 4 Jun 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 MÜRÜVVET TAŞKIR TURAN, MD (00905065536934, taskirmuruvvet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores (time frame: First 24 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 4 Jun 2025.