Living Donor HepatectomyTAP DonorNCT02708459
Transversus Abdominus Plane Block in Living Donor Hepatectomy
A study testing surgically inserted Transversus abdominus plane catheter, Intravenous morphine and Bupevecaine in people with Living Donor Hepatectomy, run by AlRefaey Kandeel at 2 sites in Egypt.
Trial summary
Comparing different drugs used in Transversus abdominus plane analgesia after donor hepatectomy. Patients will be divided into three groups; control group, Bupivecaine group, and Dexmedetomedine group according to the used drug Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Living Donor Hepatectomy
- What is being tested?
- surgically inserted Transversus abdominus plane catheter, Intravenous morphine and Bupevecaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesEgypt
- Study dates
- Mar 2016to Aug 2016
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- all living hepatectomy donors in Mansoura liver transplantation program
Who cannot join
- refusal known sensetivity to used drugs
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Mansoura university
Al Mansurah, Dakahlia Governorate, 62215
Mansoura university
Al Mansurah, Dkahleya
About this study
Comparing different drugs used in Transversus abdominus plane analgesia after donor hepatectomy. Patients will be divided into three groups; control group, Bupivecaine group, and Dexmedetomedine group according to the used drug
Read the detailed description
Transversus abdominus plane block for postoperative analgesia after donor hpatectomy surgery using three different drugs control group, Bupivecaine group, and Dexmedetomedine group
- Conditions
- Living Donor Hepatectomy
- Being tested
- surgically inserted Transversus abdominus plane catheter, Intravenous morphine, Bupevecaine, Dexmedetomedine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgically inserted Transversus abdominus plane catheterDevice
at end of surgery, a surgeon will insert catheter in Transversus abdominus plane (TAP) between internal oblique muscle and Transversus abdominus muscle
Intravenous morphineDrug
Boluses of intravenous morphine (2 mg) will be given to patients if Visual analogue scale (VAS) more than 3
BupevecaineDrug
DexmedetomedineDrug
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Control group where postoperative analgesia will be maintained by Morphine intravenous boluses (2 mg) if Visual analogue scale (VAS) scale more than 4. Receives: Drug: Intravenous morphine |
| Bupevecaine group | Active comparator | Postoperative analgesia will be maintained by 20 ml Bupevecaine (0.25%) boluses in surgically inserted TAP catheter each 8 hours for 48 hours with rescue analgesia intravenous morphine (2mg) if VAS more than 4 Receives: Device: surgically inserted Transversus abdominus plane catheter; Drug: Intravenous morphine; Drug: Bupevecaine |
| Dex group | Active comparator | catheter will surgically inserted in Transversus abdominus plane (TAP) plane before wound closure Postoperative analgesia will be maintained by Dexmedetomedine 0.4 mg/kg plus Bupevecaine 0.25 20 ml boluses each 8 hours for 48 hours in surgically inserted TAP catheter with rescue analgesia intravenous morphine (2mg) if VAS more 4 Receives: Device: surgically inserted Transversus abdominus plane catheter; Drug: Intravenous morphine; Drug: Bupevecaine; Drug: Dexmedetomedine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative morphine (mg) consumption in 1st 48 hours
Measured: 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Living Donor HepatectomyStudies 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, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- AlRefaey Kandeel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, AlRefaey Kandeel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708459
- Sponsor's protocol ID
- Abuelella TAP
- Acronym
- TAP Donor
- Status last verified
- Aug 2016
- First submitted
- 9 Feb 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominus Plane Block in Living Donor Hepatectomy
- ClinicalTrials.gov ID
- NCT02708459
- Acronym / sponsor ID
- TAP Donor / Abuelella TAP
- Conditions
- Living Donor Hepatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- AlRefaey KandeelUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Mar 2016 (estimated)
- 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.
Comparing different drugs used in Transversus abdominus plane analgesia after donor hepatectomy. Patients will be divided into three groups; control group, Bupivecaine group, and Dexmedetomedine group according to the used drug
Detailed description
Transversus abdominus plane block for postoperative analgesia after donor hpatectomy surgery using three different drugs control group, Bupivecaine group, and Dexmedetomedine group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Intravenous morphineControl group where postoperative analgesia will be maintained by Morphine intravenous boluses (2 mg) if Visual analogue scale (VAS) scale more than 4. |
| Bupevecaine group | Active comparator | Device: surgically inserted Transversus abdominus plane catheter, Drug: Intravenous morphine, Drug: BupevecainePostoperative analgesia will be maintained by 20 ml Bupevecaine (0.25%) boluses in surgically inserted TAP catheter each 8 hours for 48 hours with rescue analgesia intravenous morphine (2mg) if VAS more than 4 |
| Dex group | Active comparator | Device: surgically inserted Transversus abdominus plane catheter, Drug: Intravenous morphine, Drug: Bupevecaine, Drug: Dexmedetomedinecatheter will surgically inserted in Transversus abdominus plane (TAP) plane before wound closure Postoperative analgesia will be maintained by Dexmedetomedine 0.4 mg/kg plus Bupevecaine 0.25 20 ml boluses each 8 hours for 48 hours in surgically inserted TAP catheter with rescue analgesia intravenous morphine (2mg) if VAS more 4 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all living hepatectomy donors in Mansoura liver transplantation program
Key exclusion criteria (1 listed)
- refusal known sensetivity to used drugs
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 |
|---|---|---|
| surgically inserted Transversus abdominus plane catheterat end of surgery, a surgeon will insert catheter in Transversus abdominus plane (TAP) between internal oblique muscle and Transversus abdominus muscle | Device | Bupevecaine group, Dex group |
| Intravenous morphineBoluses of intravenous morphine (2 mg) will be given to patients if Visual analogue scale (VAS) more than 3 | Drug | Bupevecaine group, Control, Dex group |
| Bupevecaine | Drug | Bupevecaine group, Dex group |
| Dexmedetomedine | Drug | Dex group |
Primary outcome
postoperative morphine (mg) consumption in 1st 48 hours
Time frame: 48 hours postoperative
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 30 Aug 2016.
- Individual participant dataSharing planned: Yes
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgically inserted Transversus abdominus plane catheter, Intravenous morphine and Bupevecaine in people with Living Donor Hepatectomy, run by AlRefaey Kandeel at 2 sites 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: finished, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
postoperative morphine (mg) consumption in 1st 48 hours (time frame: 48 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 Aug 2016.