Abdominoplasty PatientsMaha1NCT03077581
Comparison of Three Techniques for Analgesia After Abdominoplasty
A study testing Transevrsus abdominus plane block, Rectus sheath block and local anesthesia infiltartion in people with Abdominoplasty Patients, run by Mansoura University at 1 site in Egypt.
Trial summary
This study was conducted to demonstrate post-abdominoplasty analgesic duration consequent to three different surgically infiltrated LA techniques; bilateral TAPB, bilateral RSB and subcutaneous infiltration using the same volume of 0.25% bupivacaine (40 ml). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Abdominoplasty Patients
- What is being tested?
- Transevrsus abdominus plane block, Rectus sheath block and local anesthesia infiltartion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to 15 Jun 2017
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- all patients listed for abdominoplasty
Who cannot join
- allergy to bupivacaine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Three Different Surgically Infiltrated Local Anesthetic Techniques in Abdominoplasty
This study was conducted to demonstrate post-abdominoplasty analgesic duration consequent to three different surgically infiltrated LA techniques; bilateral TAPB, bilateral RSB and subcutaneous infiltration using the same volume of 0.25% bupivacaine (40 ml). Pain score, total analgesic rescue requests and the total amount of systemic rescue analgesia used in the first postoperative day in addition to any detected postoperative complications were also recorded.
- Conditions
- Abdominoplasty Patients
- Being tested
- Transevrsus abdominus plane block, Rectus sheath block, local anesthesia infiltartion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transevrsus abdominus plane blockDrug
a blunt needle was advanced in the midaxillary line to reach the fascial layer between the internal oblique and transverse abdominis muscles detected by facial click sensation. The LA was slowly injected so as to detect any sign of toxicity or incorrect needle tip position (as resistance) requiring needle repositioning then TAPB was repeated on the opposite side.
Rectus sheath blockDrug
In RSB group, 2-3 cm from midline, about 3-5 cm above the umbilicus, the needle was advanced at right angle to the skin. The needle reaches the space between the posterior layer of the rectus sheath and rectus abdominis muscle detected by firm resistance of the posterior wall, The LA was slowly injected then the same steps were repeated on the other side.
local anesthesia infiltartionDrug
40 mls of 0.255 bupivacaine will be infiltrated at skin incision
| Study group | Role | What they receive |
|---|---|---|
| Transevrsus abdominus plane block group | Active comparator | Not described Receives: Drug: Transevrsus abdominus plane block |
| Rectus sheath block group | Active comparator | Not described Receives: Drug: Rectus sheath block |
| local infiltration group | Active comparator | Not described Receives: Drug: local anesthesia infiltartion |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption (mg)
postoperative morphine consumption in milligrams in the 1st 24 hours postoperatively
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start1 Mar 2017
- Primary completion5 Jun 2017 (estimated)
- Study completion15 Jun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominoplasty PatientsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AlRefaey Kandeel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077581
- Sponsor's protocol ID
- D.Maha abdominoplasty
- Acronym
- Maha1
- Status last verified
- Mar 2017
- First submitted
- 3 Mar 2017
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Three Different Surgically Infiltrated Local Anesthetic Techniques in Abdominoplasty
- ClinicalTrials.gov ID
- NCT03077581
- Acronym / sponsor ID
- Maha1 / D.Maha abdominoplasty
- Conditions
- Abdominoplasty Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 5 Jun 2017 (estimated)
- Study completion
- 15 Jun 2017 (estimated)
- First posted
- 13 Mar 2017 (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 was conducted to demonstrate post-abdominoplasty analgesic duration consequent to three different surgically infiltrated LA techniques; bilateral TAPB, bilateral RSB and subcutaneous infiltration using the same volume of 0.25% bupivacaine (40 ml). Pain score, total analgesic rescue requests and the total amount of systemic rescue analgesia used in the first postoperative day in addition to any detected postoperative complications were also recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transevrsus abdominus plane block group | Active comparator | Drug: Transevrsus abdominus plane block |
| Rectus sheath block group | Active comparator | Drug: Rectus sheath block |
| local infiltration group | Active comparator | Drug: local anesthesia infiltartion |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all patients listed for abdominoplasty
Key exclusion criteria (1 listed)
- allergy to bupivacaine
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 |
|---|---|---|
| Transevrsus abdominus plane blocka blunt needle was advanced in the midaxillary line to reach the fascial layer between the internal oblique and transverse abdominis muscles detected by facial click sensation. The LA was slowly injected so as to detect any sign of toxicity or incorrect needle tip position (as resistance) requiring needle repositioning then TAPB was repeated on the opposite side. | Drug | Transevrsus abdominus plane block group |
| Rectus sheath blockIn RSB group, 2-3 cm from midline, about 3-5 cm above the umbilicus, the needle was advanced at right angle to the skin. The needle reaches the space between the posterior layer of the rectus sheath and rectus abdominis muscle detected by firm resistance of the posterior wall, The LA was slowly injected then the same steps were repeated on the other side. | Drug | Rectus sheath block group |
| local anesthesia infiltartion40 mls of 0.255 bupivacaine will be infiltrated at skin incision | Drug | local infiltration group |
Primary outcome
morphine consumption (mg)
Time frame: up to 24 hours
postoperative morphine consumption in milligrams in the 1st 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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 Transevrsus abdominus plane block, Rectus sheath block and local anesthesia infiltartion in people with Abdominoplasty Patients, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Mar 2017. 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?
Results are not available in the source record.
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?
morphine consumption (mg) (time frame: up to 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 13 Mar 2017.