AnesthesiaPhase 4NCT03869047
Dexmedetomidine Added to Bupivacaine Versus Bupivacaine inTransincisionalU/S Guided Quadratus Lumborum Block in Open Renal Surgeries , A New Technique
A Phase 4 study testing Dexmedetomidine +bupivacaine and Bupivacaine in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this study is to compare the addition of dexmedetomidine to bupivacaine versus bupivacaine only in anterior QLblock(transincisional) , where the local anesthetic will be applied before wound closure at the end of surgery through the wound . Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Dexmedetomidine +bupivacaine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Mar 2019to 15 Aug 2019
- Phase
- Phase 4
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- physical status American Society of Anesthesiologist (ASA) I or II
Who cannot join
- Patients refusal
- A body mass index (BMI) >30 kg/m2
- ASA physical status >II
- major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological)
- Coagulation abnormalities
- Infection at the injection site
Show all 9Show fewer
- Allergy or contraindications to the drugs used in the study
- History of drug addiction or alcohol abuse
- A psychiatric illness, or mental retardation interfering with the evaluation of pain scores or PCA programs .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine Added to Bupivacaine Versus Bupivacaine inTransincisionalU/S Guided Quadratus Lumborum Block in Open Renal Surgeries , A New Technique :Prospective, Randomized Double- Blinded Study
The purpose of this study is to compare the addition of dexmedetomidine to bupivacaine versus bupivacaine only in anterior QLblock(transincisional) , where the local anesthetic will be applied before wound closure at the end of surgery through the wound . in combination with general anesthesia in elective open renal surgery with regard to Postoperative pain control,hemodynamic stability, and adverse effects.
- Conditions
- Anesthesia
- Being tested
- Dexmedetomidine +bupivacaine, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine +bupivacaineDrug
patients will receive combined general anesthesia and Quadratuslumborum block( transincisional ie before wound closure)with 19 mL of bupivacaine 0.20%plus 1 mic/kg of dexmedetomidine, total volume 20 ml
BupivacaineDrug
patients will receive combined general anesthesia and quadratus lumborum block (transincisional) with 20 ml of bupivacaine 0.20% .
| Study group | Role | What they receive |
|---|---|---|
| quadratus lumborum block(dexmedetomidine+bupivacaine) | Active comparator | patients will receive combined general anesthesia and Quadratuslumborum block( transincisional ie before wound closure)with 19 mL of bupivacaine 0.20%plus 1 mic/kg of dexmedetomidine ,total volume 20 ml. Receives: Drug: Dexmedetomidine +bupivacaine |
| quadratus lumborum block(bupivacaine) | Active comparator | patients will receive combined general anesthesia and quadratus lumborum block (transincisional) with 20 ml of bupivacaine 0.20%. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
First time to analgesic requirement
After extubation, an intravenous patient - controlled system, will be connected to the patient (Accufuser plus 100 ml) will be prepared with 60 ml isotonic saline containing 60 mg morphine , it will be programmed to give 0.5 ml bolus dose with lockout interval of 8 minutes. Time to first bolus will be recorded considering extubation time is the zero time
Measured: 1st 24 hour postoperatively
Secondary outcomes (1)
the secondary outcomes will be the total opioid consumption postoperatively
PCA will prepared with 60 mL of normal saline containing 60 mg of morphine, and the system will be programmed to give a 0.5 mL bolus dose with a lockout interval of 8 min.
Measured: 1st 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start6 Mar 2019
- Primary completion1 Aug 2019
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Mohammed Alansary Amin Ahmed Helwa, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869047
- Sponsor's protocol ID
- FMASU R 14/2019
- Status last verified
- May 2020
- First submitted
- 6 Mar 2019
- Last updated
- 19 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Added to Bupivacaine Versus Bupivacaine inTransincisionalU/S Guided Quadratus Lumborum Block in Open Renal Surgeries , A New Technique :Prospective, Randomized Double- Blinded Study
- ClinicalTrials.gov ID
- NCT03869047
- Acronym / sponsor ID
- FMASU R 14/2019
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 11 Mar 2019 (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 purpose of this study is to compare the addition of dexmedetomidine to bupivacaine versus bupivacaine only in anterior QLblock(transincisional) , where the local anesthetic will be applied before wound closure at the end of surgery through the wound . in combination with general anesthesia in elective open renal surgery with regard to Postoperative pain control,hemodynamic stability, and adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| quadratus lumborum block(dexmedetomidine+bupivacaine) | Active comparator | Drug: Dexmedetomidine +bupivacainepatients will receive combined general anesthesia and Quadratuslumborum block( transincisional ie before wound closure)with 19 mL of bupivacaine 0.20%plus 1 mic/kg of dexmedetomidine ,total volume 20 ml. |
| quadratus lumborum block(bupivacaine) | Active comparator | Drug: Bupivacainepatients will receive combined general anesthesia and quadratus lumborum block (transincisional) with 20 ml of bupivacaine 0.20%. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- physical status American Society of Anesthesiologist (ASA) I or II
Key exclusion criteria (9 listed)
- Patients refusal
- A body mass index (BMI) >30 kg/m2
- ASA physical status >II
- major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological)
- Coagulation abnormalities
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 |
|---|---|---|
| Dexmedetomidine +bupivacainepatients will receive combined general anesthesia and Quadratuslumborum block( transincisional ie before wound closure)with 19 mL of bupivacaine 0.20%plus 1 mic/kg of dexmedetomidine, total volume 20 ml | Drug | quadratus lumborum block(dexmedetomidine+bupivacaine) |
| Bupivacainepatients will receive combined general anesthesia and quadratus lumborum block (transincisional) with 20 ml of bupivacaine 0.20% . | Drug | quadratus lumborum block(bupivacaine) |
Primary outcome
First time to analgesic requirement
Time frame: 1st 24 hour postoperatively
After extubation, an intravenous patient - controlled system, will be connected to the patient (Accufuser plus 100 ml) will be prepared with 60 ml isotonic saline containing 60 mg morphine , it will be programmed to give 0.5 ml bolus dose with lockout interval of 8 minutes. Time to first bolus will be recorded considering extubation time is the zero time
1 secondary outcome
the secondary outcomes will be the total opioid consumption postoperatively
Time frame: 1st 24 hour
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 19 May 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine +bupivacaine and Bupivacaine in people with Anesthesia, run by Ain Shams 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 9 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 19 May 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
First time to analgesic requirement (time frame: 1st 24 hour postoperatively). 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 19 May 2020.