Modified Thoracoabdominal Nerve Block (M-TAPA)NCT07738900
Bilateral Modified Thoracoabdominal Nerve Block as an Analgesic Technique in Comparison With Bilateral Thoracic Erector Spinae Plane Block in Abdominoplasty Operations
A study testing General Anaesthesia using intravenous propofol, fentanyl intravenous, and atracurium besylate, Modified thoracoabdominal nerve block using 25 mL of bupivacaine 0.25% and Erector spinae plane block using 25 mL of bupivacaine 0.25% in people with Modified Thoracoabdominal Nerve Block (M-TAPA) and Analgesic Technique, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aimed to compare the analgesic effect of bilateral ultrasound-guided modified thoracoabdominal nerve block with bilateral ultrasound-guided erector spinae plane block in abdominoplasty surgery. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Modified Thoracoabdominal Nerve Block (M-TAPA), Analgesic Technique, Thoracic Erector Spinae Plane Block
- What is being tested?
- General Anaesthesia using intravenous propofol, fentanyl intravenous, and atracurium besylate, Modified thoracoabdominal nerve block using 25 mL of bupivacaine 0.25% and Erector spinae plane block using 25 mL of bupivacaine 0.25%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 30 Jun 2026
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 21 and 60 years.
- Both sexes.
- American Society of Anesthesiologists physical status grade I and grade II.
- Elective abdominoplasty operation.
Who cannot join
- Patient refusal.
- Local skin infection and sepsis at site of the block.
- Known allergy to local anesthetic drugs.
- Coagulopathy.
- Psychiatric diseases.
- Central or peripheral neurological disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Bilateral Modified Thoracoabdominal Nerve Block as an Analgesic Technique in Comparison With Bilateral Thoracic Erector Spinae Plane Block in Abdominoplasty Operations
This study aimed to compare the analgesic effect of bilateral ultrasound-guided modified thoracoabdominal nerve block with bilateral ultrasound-guided erector spinae plane block in abdominoplasty surgery.
Read the detailed description
Abdominoplasty is an extra-peritoneal surgery devoid of visceroperitoneal component of pain, most of pain is initially related to the abdominal wall's facial plication in addition to pain generated from the abdominal wall incision.
Ultrasound guided erector spinae plane block (ESPB) is considered relative an effective block that can be used to provide postoperative analgesia in abdominoplasty (Tulgar et al., 2018). Erector spinae plane block (ESPB) is an interfascial plane block was used to relieve chest neuropathic pain.
The modified thoracoabdominal nerve block through the perichondral approach (M-TAPA) is a novel regional nerve block that can provide optimal analgesia for both the lateral and anterior abdominal wall. It can provide wide range of analgesic coverage of the trunk (i.e., T7-T12) by a single puncture per side and has been initially reported to provide a longacting analgesia.
- Conditions
- Modified Thoracoabdominal Nerve Block (M-TAPA), Analgesic Technique, Thoracic Erector Spinae Plane Block, Abdominoplasty
- Being tested
- General Anaesthesia using intravenous propofol, fentanyl intravenous, and atracurium besylate, Modified thoracoabdominal nerve block using 25 mL of bupivacaine 0.25%, Erector spinae plane block using 25 mL of bupivacaine 0.25%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Anaesthesia using intravenous propofol, fentanyl intravenous, and atracurium besylateDrug
Patients received only standard general anesthesia using intravenous propofol (2-3 mg/kg), fentanyl intravenous (1.5µ/kg) and atracurium besylate (0.6 mg/kg).
Modified thoracoabdominal nerve block using 25 mL of bupivacaine 0.25%Drug
Patients received modified thoracoabdominal nerve block bilaterally using 25 mL of bupivacaine 0.25% and a lidocaine mixture (15 mL of bupivacaine 0.5% plus 5 mL of 2% lidocaine).
Erector spinae plane block using 25 mL of bupivacaine 0.25%Drug
Patients receive erector spinae plane block bilaterally using 25 mL of bupivacaine 0.25% and a lidocaine mixture (15 mL of bupivacaine 0.5% plus 5 mL of 2% lidocaine).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients received only standard general anesthesia. Receives: Drug: General Anaesthesia using intravenous propofol, fentanyl intravenous, and atracurium besylate |
| Modified thoracoabdominal nerve block group | Experimental | Patients received modified thoracoabdominal nerve block bilaterally Receives: Drug: Modified thoracoabdominal nerve block using 25 mL of bupivacaine 0.25% |
| Erector spinae plane block group | Experimental | Patients received an erector spinae plane block bilaterally. Receives: Drug: Erector spinae plane block using 25 mL of bupivacaine 0.25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
Intravenous pethidine (0.5mg/kg) was taken every 12 hours as rescue analgesia.
Measured: 24 hours postoperatively
Secondary outcomes (5)
Duration of analgesia
Duration of analgesia was recorded from the end of surgery till the first dose of pethidine administered.
Measured: 24 hours postoperatively
Degree of pain
A postoperative numeric rating scale (NRS) was employed to assess patients' postoperative pain levels. It is scored from 0 to 10 (0 meaning no pain and 10 meaning the worst pain). NRS was assessed at 0, 6, 12, and 24 hr postoperative.
Measured: 24 hours postoperatively
Cortisol level
Cortisol level was recorded at basal, 8 hr, and 24 hr postoperative.
Measured: 24 hours postoperatively
C-reactive protein (CRP) level
The C-reactive protein (CRP) level was recorded at basal, 8 hr, and 24 hr postoperatively.
Measured: 24 hours postoperatively
Incidence of complications
Incidence of complications such as nausea, vomiting, pruritus, and respiratory depression were recorded.
Measured: 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 posted31 Jul 2026
- Study start1 Dec 2024
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Modified Thoracoabdominal Nerve Block (M-TAPA)Studies of the same condition, open and under way.
- More trials run by Mansoura 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Othman Ibrahim Yossef, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738900
- Sponsor's protocol ID
- MD.24.11917
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bilateral Modified Thoracoabdominal Nerve Block as an Analgesic Technique in Comparison With Bilateral Thoracic Erector Spinae Plane Block in Abdominoplasty Operations
- ClinicalTrials.gov ID
- NCT07738900
- Acronym / sponsor ID
- MD.24.11917
- Conditions
- Modified Thoracoabdominal Nerve Block (M-TAPA), Analgesic Technique, Thoracic Erector Spinae Plane Block, Abdominoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 31 Jul 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.
This study aimed to compare the analgesic effect of bilateral ultrasound-guided modified thoracoabdominal nerve block with bilateral ultrasound-guided erector spinae plane block in abdominoplasty surgery.
Detailed description
Abdominoplasty is an extra-peritoneal surgery devoid of visceroperitoneal component of pain, most of pain is initially related to the abdominal wall's facial plication in addition to pain generated from the abdominal wall incision.
Ultrasound guided erector spinae plane block (ESPB) is considered relative an effective block that can be used to provide postoperative analgesia in abdominoplasty (Tulgar et al., 2018). Erector spinae plane block (ESPB) is an interfascial plane block was used to relieve chest neuropathic pain.
The modified thoracoabdominal nerve block through the perichondral approach (M-TAPA) is a novel regional nerve block that can provide optimal analgesia for both the lateral and anterior abdominal wall. It can provide wide range of analgesic coverage of the trunk (i.e., T7-T12) by a single puncture per side and has been initially reported to provide a longacting analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: General Anaesthesia using intravenous propofol, fentanyl intravenous, and atracurium besylatePatients received only standard general anesthesia. |
| Modified thoracoabdominal nerve block group | Experimental | Drug: Modified thoracoabdominal nerve block using 25 mL of bupivacaine 0.25%Patients received modified thoracoabdominal nerve block bilaterally |
| Erector spinae plane block group | Experimental | Drug: Erector spinae plane block using 25 mL of bupivacaine 0.25%Patients received an erector spinae plane block bilaterally. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 21 and 60 years.
- Both sexes.
- American Society of Anesthesiologists physical status grade I and grade II.
- Elective abdominoplasty operation.
Key exclusion criteria (6 listed)
- Patient refusal.
- Local skin infection and sepsis at site of the block.
- Known allergy to local anesthetic drugs.
- Coagulopathy.
- Psychiatric diseases.
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 |
|---|---|---|
| General Anaesthesia using intravenous propofol, fentanyl intravenous, and atracurium besylatePatients received only standard general anesthesia using intravenous propofol (2-3 mg/kg), fentanyl intravenous (1.5µ/kg) and atracurium besylate (0.6 mg/kg). | Drug | Control group |
| Modified thoracoabdominal nerve block using 25 mL of bupivacaine 0.25%Patients received modified thoracoabdominal nerve block bilaterally using 25 mL of bupivacaine 0.25% and a lidocaine mixture (15 mL of bupivacaine 0.5% plus 5 mL of 2% lidocaine). | Drug | Modified thoracoabdominal nerve block group |
| Erector spinae plane block using 25 mL of bupivacaine 0.25%Patients receive erector spinae plane block bilaterally using 25 mL of bupivacaine 0.25% and a lidocaine mixture (15 mL of bupivacaine 0.5% plus 5 mL of 2% lidocaine). | Drug | Erector spinae plane block group |
Primary outcome
Total opioid consumption
Time frame: 24 hours postoperatively
Intravenous pethidine (0.5mg/kg) was taken every 12 hours as rescue analgesia.
5 secondary outcomes
Duration of analgesia
Time frame: 24 hours postoperatively
Degree of pain
Time frame: 24 hours postoperatively
Cortisol level
Time frame: 24 hours postoperatively
C-reactive protein (CRP) level
Time frame: 24 hours postoperatively
Incidence of complications
Time frame: 24 hours postoperatively
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 31 Jul 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Anaesthesia using intravenous propofol, fentanyl intravenous, and atracurium besylate, Modified thoracoabdominal nerve block using 25 mL of bupivacaine 0.25% and Erector spinae plane block using 25 mL of bupivacaine 0.25% in people with Modified Thoracoabdominal Nerve Block (M-TAPA) and Analgesic Technique, run by Mansoura 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 4 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: finished, as of the sponsor's last update on 31 Jul 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 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?
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?
Total opioid consumption (time frame: 24 hours postoperatively). 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 31 Jul 2026.