Abdominal SurgeryNCT04920994
Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Major Abdominal Surgeries
A study testing M-TAPA block, SCTAP block and Bupivacaine Hydrochloride in people with Abdominal Surgery, run by Sameh Fathy at 1 site in Egypt.
Trial summary
This study will be conducted to evaluate efficacy of ultrasound guided modified thoracoabdominal nerves block via a new perichondrial approach (M-TAPA) for postoperative analgesia in major abdominal surgeries in comparison to subcostal transverse abdominis plane (SCTAP) block. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Abdominal Surgery
- What is being tested?
- M-TAPA block, SCTAP block and Bupivacaine Hydrochloride
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Aug 2021to 1 Jul 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology (ASA) I and II patients.
- Scheduled for elective major abdominal surgeries.
Who cannot join
- Patient's refusal.
- Altered mental status or un-cooperative patients.
- History of known sensitivity to the used anesthetics.
- Bleeding or coagulation diathesis.
- Infection at the injection site.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Anesthesia, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Comparison to Subcostal Transverse Abdominis Plane Block (TAP) in Major Abdominal Surgeries
This study will be conducted to evaluate efficacy of ultrasound guided modified thoracoabdominal nerves block via a new perichondrial approach (M-TAPA) for postoperative analgesia in major abdominal surgeries in comparison to subcostal transverse abdominis plane (SCTAP) block.
It is hypothesized that M-TAPA block will be advantageous to SCTAP block as a promising effective alternative for analgesia for major abdominal surgeries with fewer side effects.
Read the detailed description
Postoperative pain management for major abdominal surgeries can reduce postoperative respiratory dysfunction and promote early mobilization. Traditionally, opioids have been used to manage postoperative pain. However, an increasing awareness of opioid-related adverse events including respiratory depression, paralytic ileus, and sedation, has led to a shift towards utilizing opioid-sparing techniques for postoperative analgesia. As such, outcomes associated with the transverse abdominis plane block are of increasing interest. A modified thoracoabdominal nerves block via a new perichondrial approach (M-TAPA) is a novel analgesic technique that involves local anesthetic injection into the lower aspect of the chondrium. It can block thoracoabdominal nerves at T5 in cephalic direction and down to T11-T12 in caudal direction and may be an effective analgesic for major abdominal surgeries.
The aim of this study is to assess the quality of pain relief in patients who will undergo major abdominal surgery receiving either (M-TAPA) block or (SCTAP) block by comparing and evaluating the differences between the two techniques.
This prospective, randomized, comparative clinical study will include 80 patients who will be scheduled for major abdominal surgery under general anesthesia in Mansoura university hospitals. Informed written consent will be obtained from all subjects in the study after ensuring confidentiality. Eligible patients will be randomly assigned to 2 equal groups (M-TAPA group and SCTAP group) according to computer-generated table of random numbers using the permuted block randomization method. The collected data will be coded, processed, and analyzed using SPSS program. All data will be considered statistically significant if P value is ≤ 0.05.
- Conditions
- Abdominal Surgery
- Being tested
- M-TAPA block, SCTAP block, Bupivacaine Hydrochloride
- Keywords
- Thoracoabdominal nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-TAPA blockProcedure or surgery
Also called Ultrasound guided block
A high-frequency linear ultrasound probe will be used, probe will be placed on the costochondral angle in the sagittal plane and angled deeply to view the lower aspect of the chondrium in the midline, then using in-plane approach, a 22 Gauge Tuohy needle will be introduced into the lower aspect of the chondrium. The same procedure will be repeated on the contralateral side.
SCTAP blockProcedure or surgery
Also called Ultrasound guided block
A high-frequency linear ultrasound probe will be placed obliquely on the upper abdominal wall, along the subcostal margin near the midline. After identifying the rectus abdominis muscle, the ultrasound probe will be gradually moved laterally along the subcostal margin until the transversus abdominis muscle will be identified lying posterior to the rectus muscle, then using in-plane approach, a 22 Gauge Tuohy needle will be introduced medially and directed towards the transversus abdominis plane until its tip reaches the fascia between the rectus abdominis and the transverse abdominis muscles on entering the neurofascial plane. The same procedure will be repeated on the contralateral side.
Bupivacaine HydrochlorideDrug
Also called Marcaine
20 ml 0.25% bupivacaine will be injected after the negative aspiration test.
| Study group | Role | What they receive |
|---|---|---|
| Group A (M-TAPA ) | Active comparator | Ultrasound-guided M-TAPA block will be performed under strict aseptic conditions with the patient in the supine position, and bupivacaine will be administered. Receives: Procedure: M-TAPA block; Drug: Bupivacaine Hydrochloride |
| Group B (SCTAP) | Active comparator | Ultrasound-guided SCTAP block will be performed under strict aseptic conditions with the patient in the supine position, and bupivacaine will be administered. Receives: Procedure: SCTAP block; Drug: Bupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total analgesic requirements of morphine
The amount of morphine consumption in milligrams given as a rescue analgesia
Measured: Up to 24 hours after the procedure
Secondary outcomes (5)
Improvement in pain scores by Visual analogue scale (VAS)
VAS score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) will be assessed postoperatively at 1, 2, 4, 8, 12, 24 hours
Measured: Up to 24 hours after the procedure
Duration for the first analgesic request
The time of the first analgesic request for morphine in minutes will be recorded.
Measured: Up to 24 hours after the procedure
Changes in heart rate
Heart rate (beat/min) will be recorded at baseline, intraoperative fifteen-minute intervals, 1, 2, 4, 8, 12, 24 hours postoperatively
Measured: Up to 24 hours after the procedure
Changes in mean arterial blood pressure
Blood pressure (mmHg) will be recorded at baseline,intraoperative fifteen-minute intervals,1, 2, 4, 8, 12, 24 hours postoperatively
Measured: Up to 24 hours after the procedure
Incidence of adverse effects
Any adverse effects like pneumothorax, respiratory depression, nausea, vomiting, pruritus, hematoma, or allergic reactions will be recorded.
Measured: Up to 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start13 Aug 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sameh Fathy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sameh Fathy, Mansoura University
- Investigators
- Sameh M El-Sherbiny, MD, Principal investigator, Mansoura Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920994
- Sponsor's protocol ID
- Modified TAPA Block
- Status last verified
- Jul 2022
- First submitted
- 3 Jun 2021
- Last updated
- 11 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Comparison to Subcostal Transverse Abdominis Plane Block (TAP) in Major Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT04920994
- Acronym / sponsor ID
- Modified TAPA Block
- Conditions
- Abdominal Surgery
- Keywords
- Thoracoabdominal nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sameh FathyUniversity, hospital or other
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 10 Jun 2021 (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 will be conducted to evaluate efficacy of ultrasound guided modified thoracoabdominal nerves block via a new perichondrial approach (M-TAPA) for postoperative analgesia in major abdominal surgeries in comparison to subcostal transverse abdominis plane (SCTAP) block.
It is hypothesized that M-TAPA block will be advantageous to SCTAP block as a promising effective alternative for analgesia for major abdominal surgeries with fewer side effects.
Detailed description
Postoperative pain management for major abdominal surgeries can reduce postoperative respiratory dysfunction and promote early mobilization. Traditionally, opioids have been used to manage postoperative pain. However, an increasing awareness of opioid-related adverse events including respiratory depression, paralytic ileus, and sedation, has led to a shift towards utilizing opioid-sparing techniques for postoperative analgesia. As such, outcomes associated with the transverse abdominis plane block are of increasing interest. A modified thoracoabdominal nerves block via a new perichondrial approach (M-TAPA) is a novel analgesic technique that involves local anesthetic injection into the lower aspect of the chondrium. It can block thoracoabdominal nerves at T5 in cephalic direction and down to T11-T12 in caudal direction and may be an effective analgesic for major abdominal surgeries.
The aim of this study is to assess the quality of pain relief in patients who will undergo major abdominal surgery receiving either (M-TAPA) block or (SCTAP) block by comparing and evaluating the differences between the two techniques.
This prospective, randomized, comparative clinical study will include 80 patients who will be scheduled for major abdominal surgery under general anesthesia in Mansoura university hospitals. Informed written consent will be obtained from all subjects in the study after ensuring confidentiality. Eligible patients will be randomly assigned to 2 equal groups (M-TAPA group and SCTAP group) according to computer-generated table of random numbers using the permuted block randomization method. The collected data will be coded, processed, and analyzed using SPSS program. All data will be considered statistically significant if P value is ≤ 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (M-TAPA ) | Active comparator | Procedure: M-TAPA block, Drug: Bupivacaine HydrochlorideUltrasound-guided M-TAPA block will be performed under strict aseptic conditions with the patient in the supine position, and bupivacaine will be administered. |
| Group B (SCTAP) | Active comparator | Procedure: SCTAP block, Drug: Bupivacaine HydrochlorideUltrasound-guided SCTAP block will be performed under strict aseptic conditions with the patient in the supine position, and bupivacaine will be administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiology (ASA) I and II patients.
- Scheduled for elective major abdominal surgeries.
Key exclusion criteria (5 listed)
- Patient's refusal.
- Altered mental status or un-cooperative patients.
- History of known sensitivity to the used anesthetics.
- Bleeding or coagulation diathesis.
- Infection at the injection site.
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 |
|---|---|---|
| M-TAPA blockAlso: Ultrasound guided blockA high-frequency linear ultrasound probe will be used, probe will be placed on the costochondral angle in the sagittal plane and angled deeply to view the lower aspect of the chondrium in the midline, then using in-plane approach, a 22 Gauge Tuohy needle will be introduced into the lower aspect of the chondrium. The same procedure will be repeated on the contralateral side. | Procedure or surgery | Group A (M-TAPA ) |
| SCTAP blockAlso: Ultrasound guided blockA high-frequency linear ultrasound probe will be placed obliquely on the upper abdominal wall, along the subcostal margin near the midline. After identifying the rectus abdominis muscle, the ultrasound probe will be gradually moved laterally along the subcostal margin until the transversus abdominis muscle will be identified lying posterior to the rectus muscle, then using in-plane approach, a 22 Gauge Tuohy needle will be introduced medially and directed towards the transversus abdominis plane until its tip reaches the fascia between the rectus abdominis and the transverse abdominis muscles on entering the neurofascial plane. The same procedure will be repeated on the contralateral side. | Procedure or surgery | Group B (SCTAP) |
| Bupivacaine HydrochlorideAlso: Marcaine20 ml 0.25% bupivacaine will be injected after the negative aspiration test. | Drug | Group A (M-TAPA ), Group B (SCTAP) |
Primary outcome
Total analgesic requirements of morphine
Time frame: Up to 24 hours after the procedure
The amount of morphine consumption in milligrams given as a rescue analgesia
5 secondary outcomes
Improvement in pain scores by Visual analogue scale (VAS)
Time frame: Up to 24 hours after the procedure
Duration for the first analgesic request
Time frame: Up to 24 hours after the procedure
Changes in heart rate
Time frame: Up to 24 hours after the procedure
Changes in mean arterial blood pressure
Time frame: Up to 24 hours after the procedure
Incidence of adverse effects
Time frame: Up to 24 hours after the procedure
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 2022.
- 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.
Sameh M El-Sherbiny, MD principal investigator
Mansoura Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M-TAPA block, SCTAP block and Bupivacaine Hydrochloride in people with Abdominal Surgery, run by Sameh Fathy 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 2 inclusion and 5 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 2022. 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 analgesic requirements of morphine (time frame: Up to 24 hours after the procedure). 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 11 Jul 2022.