AbdominoplastyNCT06550180
The Additive Analgesic Effects of Transversus Abdominis Plane Block in Abdominoplasty Under Spinal Anaesthesia
A study testing Spinal anaesthesia group (S) and Subcostal TAP block and spinal anesthesia group (STAP) in people with Abdominoplasty and Spinal Anaesthesia, run by Helwan University at 1 site in Egypt.
Trial summary
The primary outcome is the time to first request of opioid analgesia. The secondary outcomes are intraoperative analgesic needs, incidence of conversion to general anaesthesia, the total opioid dose in 24 hours, Visual analogue scale (VAS) scores at 2, 4, 6, 12, and 24 hours postoperatively, and the incidence of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Abdominoplasty, Spinal Anaesthesia, Transversus Abdominis Plane Block (TAP Block)
- What is being tested?
- Spinal anaesthesia group (S) and Subcostal TAP block and spinal anesthesia group (STAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 28 May 2024to 1 Apr 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anaesthesiologists physical status grade I and grade II.
- Age > 18 years and less than 65 years.
- Both sexes.
Who cannot join
- Patient refusal.
- -. Bleeding or coagulation abnormality.
- Local skin infection and sepsis at site of the block.
- Known hypersensitivity to the study drugs.
- Body Mass Index > 50 Kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Additive Analgesic Effects of Transversus Abdominis Plane Block in Abdominoplasty Under Spinal Anaesthesia: A Randomized Controlled Study
The primary outcome is the time to first request of opioid analgesia. The secondary outcomes are intraoperative analgesic needs, incidence of conversion to general anaesthesia, the total opioid dose in 24 hours, Visual analogue scale (VAS) scores at 2, 4, 6, 12, and 24 hours postoperatively, and the incidence of postoperative side effects (nausea, vomiting, hypotension, bradycardia, and pruritic).
Read the detailed description
Abdominoplasty is designed to remove fat, skin laxity, and excess skin with the abdominal skin flap. It is a moderately invasive extraperitoneal procedure with or without liposuction. Ambulatory office-based abdominoplasty procedures have recently increased owing to lower cost and global availability of plastic surgeons in addition to better and safer anaesthetic techniques Spinal anaesthesia has many advantages such as pre-emptive analgesia, better control of pain, suppression of the surgical stress response, preservation of perioperative immune function, preservation of oxygenation and pulmonary functional residual capacity and improved visceral vascular flow in addition to reduction in the incidence of venous thrombotic disease and hence pulmonary embolism, as it facilitates early ambulation The addition of adjuvant drugs to local anesthetics and augmenting spinal anesthesia with peripheral nerve blocks would provide time for prolonged surgeries, and it is the ideal technique for procedures below T3-T4. The investigators assume that performing a transversus abdominis plane block (TAP block) just before spinal anesthesia in abdominoplasty would prolong the duration of postoperative analgesia and lessen the number of cases needing sedation or conversion to general anesthesia when compared to spinal anesthesia alone.
- Being tested
- Spinal anaesthesia group (S), Subcostal TAP block and spinal anesthesia group (STAP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anaesthesia group (S)Drug
Spinal anaesthesia is given to all patients in S group. They will receive 20 mg of 0.5% hyperbaric bupivacaine plus 25 microgram fentanyl
Subcostal TAP block and spinal anesthesia group (STAP)Drug
patient receive Subcostal TAP block before spinal anesthesia. Patients in STAP group will receive 20 ml of 0.25% isobaric bupivacaine for each side before spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Spinal anaesthesia group (S) | Experimental | patient in S group They will receive 20 mg of 0.5% hyperbaric bupivacaine plus 25 microgram fentanyl. Receives: Drug: Spinal anaesthesia group (S) |
| oblique Subcostal TAP block and spinal anaesthesia group (OSTAP) | Experimental | Patients in (OSTAP) groups had spinal anesthesia administered with 20 mg of 0.5% hyperbaric bupivacaine and 25 mcg of fentanyl. Immediately after giving spinal anesthesia, individuals in the OSTAP group received 35 ml of 0.25% isobaric bupivacaine on each side. Receives: Drug: 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.
The primary outcome is the time to first request of opioid analgesia.
assessment of pain by visual analogue scale (VAS) is a 10 cm horizontal line labeled "no pain" at one end and "worst pain" on the other end.
Measured: 24 hours
Secondary outcomes (1)
total dose of intraoperative analgesic needs
opioid dose by microgram
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start28 May 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbdominoplastyStudies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Ali Hassan, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550180
- Sponsor's protocol ID
- CT2024-001
- Status last verified
- May 2024
- First submitted
- 7 Aug 2024
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Additive Analgesic Effects of Transversus Abdominis Plane Block in Abdominoplasty Under Spinal Anaesthesia: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06550180
- Acronym / sponsor ID
- CT2024-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 28 May 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 12 Aug 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.
The primary outcome is the time to first request of opioid analgesia. The secondary outcomes are intraoperative analgesic needs, incidence of conversion to general anaesthesia, the total opioid dose in 24 hours, Visual analogue scale (VAS) scores at 2, 4, 6, 12, and 24 hours postoperatively, and the incidence of postoperative side effects (nausea, vomiting, hypotension, bradycardia, and pruritic).
Detailed description
Abdominoplasty is designed to remove fat, skin laxity, and excess skin with the abdominal skin flap. It is a moderately invasive extraperitoneal procedure with or without liposuction. Ambulatory office-based abdominoplasty procedures have recently increased owing to lower cost and global availability of plastic surgeons in addition to better and safer anaesthetic techniques Spinal anaesthesia has many advantages such as pre-emptive analgesia, better control of pain, suppression of the surgical stress response, preservation of perioperative immune function, preservation of oxygenation and pulmonary functional residual capacity and improved visceral vascular flow in addition to reduction in the incidence of venous thrombotic disease and hence pulmonary embolism, as it facilitates early ambulation The addition of adjuvant drugs to local anesthetics and augmenting spinal anesthesia with peripheral nerve blocks would provide time for prolonged surgeries, and it is the ideal technique for procedures below T3-T4. The investigators assume that performing a transversus abdominis plane block (TAP block) just before spinal anesthesia in abdominoplasty would prolong the duration of postoperative analgesia and lessen the number of cases needing sedation or conversion to general anesthesia when compared to spinal anesthesia alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal anaesthesia group (S) | Experimental | Drug: Spinal anaesthesia group (S)patient in S group They will receive 20 mg of 0.5% hyperbaric bupivacaine plus 25 microgram fentanyl. |
| oblique Subcostal TAP block and spinal anaesthesia group (OSTAP) | Experimental | Drug: Subcostal TAP block and spinal anesthesia group (STAP)Patients in (OSTAP) groups had spinal anesthesia administered with 20 mg of 0.5% hyperbaric bupivacaine and 25 mcg of fentanyl. Immediately after giving spinal anesthesia, individuals in the OSTAP group received 35 ml of 0.25% isobaric bupivacaine on each side. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anaesthesiologists physical status grade I and grade II.
- Age > 18 years and less than 65 years.
- Both sexes.
Key exclusion criteria (5 listed)
- Patient refusal.
- -. Bleeding or coagulation abnormality.
- Local skin infection and sepsis at site of the block.
- Known hypersensitivity to the study drugs.
- Body Mass Index > 50 Kg/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 |
|---|---|---|
| Spinal anaesthesia group (S)Spinal anaesthesia is given to all patients in S group. They will receive 20 mg of 0.5% hyperbaric bupivacaine plus 25 microgram fentanyl | Drug | Spinal anaesthesia group (S) |
| Subcostal TAP block and spinal anesthesia group (STAP)patient receive Subcostal TAP block before spinal anesthesia. Patients in STAP group will receive 20 ml of 0.25% isobaric bupivacaine for each side before spinal anesthesia | Drug | oblique Subcostal TAP block and spinal anaesthesia group (OSTAP) |
Primary outcome
The primary outcome is the time to first request of opioid analgesia.
Time frame: 24 hours
assessment of pain by visual analogue scale (VAS) is a 10 cm horizontal line labeled "no pain" at one end and "worst pain" on the other end.
1 secondary outcome
total dose of intraoperative analgesic needs
Time frame: 24 hours
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 16 Apr 2025.
- 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 Spinal anaesthesia group (S) and Subcostal TAP block and spinal anesthesia group (STAP) in people with Abdominoplasty and Spinal Anaesthesia, run by Helwan 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 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 16 Apr 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?
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?
The primary outcome is the time to first request of opioid analgesia. (time frame: 24 hours). 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 16 Apr 2025.