Renal FailureNCT02858622
Dual Transversus Abdominis Plane Block in Pediatric Renal Transplant: Effect on Pain Control
A study testing bupivacaine, Pethidine and perfalgan in people with Renal Failure, run by Cairo University at 1 site in Egypt.
Trial summary
Alleviating pain in children undergoing renal transplant is extremely challenging. Large incisions as those of renal transplant (Gibson's incision) require special techniques of pain control that don't affect hemodynamics or renal function. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Renal Failure
- What is being tested?
- bupivacaine, Pethidine and perfalgan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2016to Mar 2019
- 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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 3-16 years
- end stage renal disease
- no known allergy to bupivacaine
- both sexes
Who cannot join
- known allergy to bupivacaine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unilateral Dual Transversus Abdominis Plane Block in Pediatric Renal Transplant: A Randomized Control Study
Alleviating pain in children undergoing renal transplant is extremely challenging. Large incisions as those of renal transplant (Gibson's incision) require special techniques of pain control that don't affect hemodynamics or renal function. Since the transplant incision doesn't cross midline; a dual-TAP block is thought to be effective in providing pain control in such procedure as it will anesthetize the dermatomes T6-T12, the muscles of the anterior abdominal wall together with the underlying parietal peritoneum.
- Conditions
- Renal Failure
- Being tested
- bupivacaine, Pethidine, perfalgan, fentanyl
- Keywords
- pediatric, renal transplant, pain, dual TAB
- Medical subject headings
- Renal Insufficiency, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaineDrug
bupivacaine 0.25% at a dose 2 mg/kg in the transversus abdominis plane
PethidineDrug
pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia
perfalganDrug
intravenous paracetamol
fentanylDrug
| Study group | Role | What they receive |
|---|---|---|
| dual TAB group | Active comparator | 22 patients will receive unilateral dual transversus abdominis plane (TAB) block USING bupivacaine 0.25% at a dose of 2 mg/kg Receives: Drug: bupivacaine; Drug: Pethidine; Drug: perfalgan; Drug: fentanyl |
| control group | Sham comparator | 22 patients who will not receive dual TAB block Receives: Drug: Pethidine; Drug: perfalgan; Drug: fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
total dose of rescue analgesia
pethidine given as rescue analgesia postoperative.
Measured: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
Secondary outcomes (5)
pain scoring system (objective behavioural pain score)
Measured: from the time of transfer to the nephrology ICU, every hour for the first 24 hours postoperative
Intraoperative blood pressure
measure systolic and diastolic blood pressure
Measured: from the induction of anesthesia till end of surgery at half an hour intervals average duration is 4 hours
postoperative blood pressure
record systolic and diastolic blood pressure every hour for the first 24 hours postoperative
Measured: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
postoperative heart rate
Measured: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
intraoperative heart rate
Measured: from the induction of anesthesia till end of surgery at half an hour intervals average duration is 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Mohamed Abd el moneim Soaida, MD, Cairo University
- Investigators
- Sherif M Soaida, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858622
- Sponsor's protocol ID
- SMS2016-1
- Status last verified
- May 2019
- First submitted
- 5 Apr 2016
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Dual Transversus Abdominis Plane Block in Pediatric Renal Transplant: A Randomized Control Study
- ClinicalTrials.gov ID
- NCT02858622
- Acronym / sponsor ID
- SMS2016-1
- Conditions
- Renal Failure
- Keywords
- pediatric, renal transplant, pain, dual TAB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jan 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 8 Aug 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.
Alleviating pain in children undergoing renal transplant is extremely challenging. Large incisions as those of renal transplant (Gibson's incision) require special techniques of pain control that don't affect hemodynamics or renal function. Since the transplant incision doesn't cross midline; a dual-TAP block is thought to be effective in providing pain control in such procedure as it will anesthetize the dermatomes T6-T12, the muscles of the anterior abdominal wall together with the underlying parietal peritoneum.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dual TAB group | Active comparator | Drug: bupivacaine, Drug: Pethidine, Drug: perfalgan, Drug: fentanyl22 patients will receive unilateral dual transversus abdominis plane (TAB) block USING bupivacaine 0.25% at a dose of 2 mg/kg |
| control group | Sham comparator | Drug: Pethidine, Drug: perfalgan, Drug: fentanyl22 patients who will not receive dual TAB block |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 3-16 years
- end stage renal disease
- no known allergy to bupivacaine
- both sexes
Key exclusion criteria (1 listed)
- known 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 |
|---|---|---|
| bupivacainebupivacaine 0.25% at a dose 2 mg/kg in the transversus abdominis plane | Drug | dual TAB group |
| Pethidinepethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia | Drug | control group, dual TAB group |
| perfalganintravenous paracetamol | Drug | control group, dual TAB group |
| fentanyl | Drug | control group, dual TAB group |
Primary outcome
total dose of rescue analgesia
Time frame: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
pethidine given as rescue analgesia postoperative.
5 secondary outcomes
pain scoring system (objective behavioural pain score)
Time frame: from the time of transfer to the nephrology ICU, every hour for the first 24 hours postoperative
Intraoperative blood pressure
Time frame: from the induction of anesthesia till end of surgery at half an hour intervals average duration is 4 hours
postoperative blood pressure
Time frame: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
postoperative heart rate
Time frame: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
intraoperative heart rate
Time frame: from the induction of anesthesia till end of surgery at half an hour intervals average duration is 4 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 7 May 2019.
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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.
Sherif M Soaida, M.D. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bupivacaine, Pethidine and perfalgan in people with Renal Failure, run by Cairo 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 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 7 May 2019. 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. Some participants in this study may receive a placebo. 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 dose of rescue analgesia (time frame: from the time of transfer of the patient to the intensive care unit at one hour intervals for 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 7 May 2019.