Laparoscopic CholecystectomyNCT06588777
Ultrasound Guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) Versus Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy
A study testing Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and Quadratus lumborum block in people with Laparoscopic Cholecystectomy and Modified Thoracoabdominal Nerve Block, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to compare the efficacy of using Ultrasound guided modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) versus quadratus lumborum block for postoperative analgesia in laparoscopic cholecystectomy under general anesthesia. Read more about this study
- Who is it for?
- Ages 21 to 71 years
- Conditions the study is for
- Laparoscopic Cholecystectomy, Modified Thoracoabdominal Nerve Block, Quadratus Lumborum Block
- What is being tested?
- Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and Quadratus lumborum block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 30 Dec 2025
- 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 21 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aging ≥ 21 years to ≤ 70 of both sexes.
- Patients undergoing Laparoscopic cholecystectomy surgeries.
- ASA physical status classes I - II.
Who cannot join
- Patient's refusal of procedure or participation in the study.
- ASA classes III or above.
- Coagulopathy and bleeding disorders.
- Evidence of Local skin infections at site of injection.
- Body mass index >40kg/m2
- A history of relevant local anesthetic allergy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to compare the efficacy of using Ultrasound guided modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) versus quadratus lumborum block for postoperative analgesia in laparoscopic cholecystectomy under general anesthesia.
- Conditions
- Laparoscopic Cholecystectomy, Modified Thoracoabdominal Nerve Block, Quadratus Lumborum Block
- Being tested
- Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA), Quadratus lumborum block
- Keywords
- Laparoscopic cholecystectomy, modified thoracoabdominal nerve block, quadratus lumborum block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA)Procedure or surgery
Also called (M-TAPA)
transversus abdominis, internal oblique, and external oblique muscles will be identified with a high-frequency (10 MHz) linear probe on the costochondral angle in the sagittal plane under ultrasound guidance at the 10th costal margin. A deep angle was given to the costochondral angle at the edge of the 10th costal margin with the probe in the sagittal direction to view the lower surface of the costal cartilage in the midline. A 22-G, 100-mm block needle will be inserted in the cranial direction using the in-plane technique and the needle tip will be moved to the posterior aspect of the 10th costal cartilage. It is noted that the needle tip never crossed the cranial edge of the 10th costal cartilage
Quadratus lumborum blockProcedure or surgery
Also called (QLB)
using ultrasound guidance (Sonosite turbo M, Bothell, Washington, USA) and a curved ultrasound probe (2.5-7.5 MHz). The probe will be placed in the mid-axillary line between the lower costal margin and the iliac crest in a transverse plane to view all abdominal layers. The probe will be moved towards the posterior axillary line, to reach a point where all three abdominal muscle layers merge to form aponeurosis.
The aponeurosis will then be followed dorsally until the quadratus lumborum muscle is seen deep to transversalis fascia with its attachment to the transverse process of the L4 vertebral body. A 22 G, 100 mm, blunt, insulated nerve block needle will be inserted 1 cm medial to the probe and advanced using the in-plane technique with ultrasound real-time assessment. The injection site will be the junction of transversalis fascia and the anterolateral border of quadratus lumborum muscle
| Study group | Role | What they receive |
|---|---|---|
| Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) | Experimental | Using the in plane technique A deep angle was given to the costochondral angle at the edge of the 10th costal margin with the probe in the sagittal direction to view the lower surface of the costal cartilage in the midline. A 22-G, 100-mm block needle will be inserted in the cranial direction using the in-plane technique and the needle tip will be moved to the posterior aspect of the 10th costal cartilage. It is noted that the needle tip never crossed the cranial edge of the 10th costal cartilage and 20 mL of 0.25% bupivacaine will be injected into the lower surface of the chondrium to make Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA). Receives: Procedure: Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) |
| Quadratus lumborum block | Experimental | Using the in plane technique the probe will be placed in the mid-axillary line between the lower costal margin and the iliac crest in a transverse plane to view all abdominal layers. The probe will be moved towards the posterior axillary line, to reach a point where all three abdominal muscle layers merge to form aponeurosis.
The aponeurosis will then be followed dorsally until the quadratus lumborum muscle is seen deep to transversalis fascia with its attachment to the transverse process of the L4 vertebral body. A 22 G, 100 mm, blunt, insulated nerve block needle will be inserted 1 cm medial to the probe and advanced using the in-plane technique with ultrasound real-time assessment. The injection site will be the junction of transversalis fascia and the anterolateral border of quadratus lumborum muscle. Receives: Procedure: Quadratus lumborum block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first Rescue Analgesia
Is to measure the first time to resque analgesia postoperative (24 hours)
Measured: 24 hours postoperative
Secondary outcomes (4)
The total requirements of rescue analgesia Meperidine (pethidine) over the first 24 hours postoperative
Measured: 24 hours postoperative
Heart rate
Measured: at intervals of 0 (PACU), 1, 2, 4, 6, 12, 18 and 24 hours postoperatively
Blood pressure
Measured: at intervals of 0 (PACU), 1, 2, 4, 6, 12, 18 and 24 hours postoperatively
Spo2 measuring
Measured: at intervals of 0 (PACU), 1, 2, 4, 6, 12, 18 and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Sep 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (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.
- More trials run by Ain Shams 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hassan Helmy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588777
- Sponsor's protocol ID
- MD92/2024
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2024
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) Versus Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06588777
- Acronym / sponsor ID
- MD92/2024
- Conditions
- Laparoscopic Cholecystectomy, Modified Thoracoabdominal Nerve Block, Quadratus Lumborum Block
- Keywords
- Laparoscopic cholecystectomy, modified thoracoabdominal nerve block, quadratus lumborum block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (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 compare the efficacy of using Ultrasound guided modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) versus quadratus lumborum block for postoperative analgesia in laparoscopic cholecystectomy under general anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) | Experimental | Procedure: Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA)Using the in plane technique A deep angle was given to the costochondral angle at the edge of the 10th costal margin with the probe in the sagittal direction to view the lower surface of the costal cartilage in the midline. A 22-G, 100-mm block needle will be inserted in the cranial direction using the in-plane technique and the needle tip will be moved to the posterior aspect of the 10th costal cartilage. It is noted that the needle tip never crossed the cranial edge of the 10th costal cartilage and 20 mL of 0.25% bupivacaine will be injected into the lower surface of the chondrium to make Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA). |
| Quadratus lumborum block | Experimental | Procedure: Quadratus lumborum blockUsing the in plane technique the probe will be placed in the mid-axillary line between the lower costal margin and the iliac crest in a transverse plane to view all abdominal layers. The probe will be moved towards the posterior axillary line, to reach a point where all three abdominal muscle layers merge to form aponeurosis. The aponeurosis will then be followed dorsally until the quadratus lumborum muscle is seen deep to transversalis fascia with its attachment to the transverse process of the L4 vertebral body. A 22 G, 100 mm, blunt, insulated nerve block needle will be inserted 1 cm medial to the probe and advanced using the in-plane technique with ultrasound real-time assessment. The injection site will be the junction of transversalis fascia and the anterolateral border of quadratus lumborum muscle. |
Who may qualify
- Ages
- 21 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aging ≥ 21 years to ≤ 70 of both sexes.
- Patients undergoing Laparoscopic cholecystectomy surgeries.
- ASA physical status classes I - II.
Key exclusion criteria (6 listed)
- Patient's refusal of procedure or participation in the study.
- ASA classes III or above.
- Coagulopathy and bleeding disorders.
- Evidence of Local skin infections at site of injection.
- Body mass index >40kg/m2
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 |
|---|---|---|
| Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA)Also: (M-TAPA)transversus abdominis, internal oblique, and external oblique muscles will be identified with a high-frequency (10 MHz) linear probe on the costochondral angle in the sagittal plane under ultrasound guidance at the 10th costal margin. A deep angle was given to the costochondral angle at the edge of the 10th costal margin with the probe in the sagittal direction to view the lower surface of the costal cartilage in the midline. A 22-G, 100-mm block needle will be inserted in the cranial direction using the in-plane technique and the needle tip will be moved to the posterior aspect of the 10th costal cartilage. It is noted that the needle tip never crossed the cranial edge of the 10th costal cartilage | Procedure or surgery | Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) |
| Quadratus lumborum blockAlso: (QLB)using ultrasound guidance (Sonosite turbo M, Bothell, Washington, USA) and a curved ultrasound probe (2.5-7.5 MHz). The probe will be placed in the mid-axillary line between the lower costal margin and the iliac crest in a transverse plane to view all abdominal layers. The probe will be moved towards the posterior axillary line, to reach a point where all three abdominal muscle layers merge to form aponeurosis. The aponeurosis will then be followed dorsally until the quadratus lumborum muscle is seen deep to transversalis fascia with its attachment to the transverse process of the L4 vertebral body. A 22 G, 100 mm, blunt, insulated nerve block needle will be inserted 1 cm medial to the probe and advanced using the in-plane technique with ultrasound real-time assessment. The injection site will be the junction of transversalis fascia and the anterolateral border of quadratus lumborum muscle | Procedure or surgery | Quadratus lumborum block |
Primary outcome
Time to first Rescue Analgesia
Time frame: 24 hours postoperative
Is to measure the first time to resque analgesia postoperative (24 hours)
4 secondary outcomes
The total requirements of rescue analgesia Meperidine (pethidine) over the first 24 hours postoperative
Time frame: 24 hours postoperative
Heart rate
Time frame: at intervals of 0 (PACU), 1, 2, 4, 6, 12, 18 and 24 hours postoperatively
Blood pressure
Time frame: at intervals of 0 (PACU), 1, 2, 4, 6, 12, 18 and 24 hours postoperatively
Spo2 measuring
Time frame: at intervals of 0 (PACU), 1, 2, 4, 6, 12, 18 and 24 hours postoperatively
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 30 Sep 2025.
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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 Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and Quadratus lumborum block in people with Laparoscopic Cholecystectomy and Modified Thoracoabdominal Nerve Block, run by Ain Shams University at 1 site in Egypt.
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 6 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 30 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 Egypt. 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 Ahmed Hassan, Master (01158195158, ahmedhassan199466@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first Rescue Analgesia (time frame: 24 hours postoperative). 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 30 Sep 2025.