Posterior Lumbosacral Spine Fixation SurgeriesPhase 1/2NCT05590234
Dexmedetomidine Combined With Bupivacaine for Erector Spinae Plane Block
A Phase 1/2 study testing Dexmedetomidine injection, Bupivacaine 0.25% Injectable Solution and normal saline in people with Posterior Lumbosacral Spine Fixation Surgeries, run by October 6 University at 1 site in Egypt.
Trial summary
As the posterior lumbosacral spine fixation surgeries are common spine procedures done nowadays due to different causes and as this spine procedure is mostly accompanied with moderate to severe postoperative pain, so it is necessary to find an effective and efficient postoperative analgesia for patients with this… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Posterior Lumbosacral Spine Fixation Surgeries
- What is being tested?
- Dexmedetomidine injection, Bupivacaine 0.25% Injectable Solution and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2022to 20 Jul 2023
- Phase
- Phase 1/2
- 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
- elective posterior lumbosacral spine fixation and fusion surgery due to different causes that diagnosed clinically and radiologically including MRI and Plain X ray
Who cannot join
- hypersensitivity to the drugs used in the study [local anesthetics, non-steroidal anti-inflammatory drugs, opioids and the drug under investigation (dexmedetomidine)]
- patients with any contraindication to regional anesthesia as skin infections at the site of the block
- history of bleeding disorders or receiving anticoagulant medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine Combined With Bupivacaine for Erector Spinae Plane Block Versus Bupivacaine Alone for Postoperative Pain Control of Posterior Lumbosacral Spine Fixation Surgeries
As the posterior lumbosacral spine fixation surgeries are common spine procedures done nowadays due to different causes and as this spine procedure is mostly accompanied with moderate to severe postoperative pain, so it is necessary to find an effective and efficient postoperative analgesia for patients with this surgery.
- Being tested
- Dexmedetomidine injection, Bupivacaine 0.25% Injectable Solution, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine injectionDrug
1ug/kg dexmedetomidine plus 20 mL of bupivacaine 0.25%
Bupivacaine 0.25% Injectable SolutionDrug
20 ml of bupivacaine 0.25%,
normal salineDrug
20 ml of normal saline 0.9%.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine combined with bupivacaine group (DB group) | Active comparator | patients received 1ug/kg dexmedetomidine plus 20 mL of bupivacaine 0.25%, Receives: Drug: Dexmedetomidine injection; Drug: Bupivacaine 0.25% Injectable Solution |
| bupivacaine 0.25%, | Active comparator | patients received 20 ml of bupivacaine 0.25% Receives: Drug: Bupivacaine 0.25% Injectable Solution |
| control group (S group) | Placebo comparator | patients received 20 ml of normal saline 0.9%. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative visual analogue scale (VAS)
The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.
Measured: the first 24 hours postoperative
Amount of post operative opioid consumption for the first 24 hours
Amount of total opioid consumption for 24 hours postoperative
Measured: the first 24 hours postoperative
Secondary outcomes (2)
Postoperative visual analogue scale (VAS)
The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.
Measured: the second 24 hour postoperative
Amount of post operative opioid consumption for the second 24 hours
Amount of total opioid consumption for the second 24 hours postoperative
Measured: the second 24 hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start15 Nov 2022
- Primary completion1 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posterior Lumbosacral Spine Fixation SurgeriesStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, engy wahsh, October 6 University
- Investigators
- Abdelmaksod Mohammed M Mousa, MD, Principal investigator, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590234
- Sponsor's protocol ID
- PRC-Me-2210035
- Status last verified
- Jul 2023
- First submitted
- 17 Oct 2022
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abu El Hassan SHA, Wahsh EA, Mousa AM, Ibrahim ARN, Mohammed EL. Comparative Study Between Dexmedetomidine with Bupivacaine and Bupivacaine Alone in Erector Spinae Plane Block for Postoperative Pain Control of Posterior Lumbosacral Spine Fixation Surgeries: A Randomized Controlled Trial. Drug Des Devel Ther. 2024 Feb 7;18:351-363. doi: 10.2147/DDDT.S444485. eCollection 2024.
PubMed 38344257
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Combined With Bupivacaine for Erector Spinae Plane Block Versus Bupivacaine Alone for Postoperative Pain Control of Posterior Lumbosacral Spine Fixation Surgeries
- ClinicalTrials.gov ID
- NCT05590234
- Acronym / sponsor ID
- PRC-Me-2210035
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 21 Oct 2022 (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.
As the posterior lumbosacral spine fixation surgeries are common spine procedures done nowadays due to different causes and as this spine procedure is mostly accompanied with moderate to severe postoperative pain, so it is necessary to find an effective and efficient postoperative analgesia for patients with this surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine combined with bupivacaine group (DB group) | Active comparator | Drug: Dexmedetomidine injection, Drug: Bupivacaine 0.25% Injectable Solutionpatients received 1ug/kg dexmedetomidine plus 20 mL of bupivacaine 0.25%, |
| bupivacaine 0.25%, | Active comparator | Drug: Bupivacaine 0.25% Injectable Solutionpatients received 20 ml of bupivacaine 0.25% |
| control group (S group) | Placebo comparator | Drug: normal salinepatients received 20 ml of normal saline 0.9%. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective posterior lumbosacral spine fixation and fusion surgery due to different causes that diagnosed clinically and radiologically including MRI and Plain X ray
Key exclusion criteria (3 listed)
- hypersensitivity to the drugs used in the study [local anesthetics, non-steroidal anti-inflammatory drugs, opioids and the drug under investigation (dexmedetomidine)]
- patients with any contraindication to regional anesthesia as skin infections at the site of the block
- history of bleeding disorders or receiving anticoagulant medications
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 injection1ug/kg dexmedetomidine plus 20 mL of bupivacaine 0.25% | Drug | Dexmedetomidine combined with bupivacaine group (DB group) |
| Bupivacaine 0.25% Injectable Solution20 ml of bupivacaine 0.25%, | Drug | Dexmedetomidine combined with bupivacaine group (DB group), bupivacaine 0.25%, |
| normal saline20 ml of normal saline 0.9%. | Drug | control group (S group) |
Primary outcome
Postoperative visual analogue scale (VAS)
Time frame: the first 24 hours postoperative
The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.
Amount of post operative opioid consumption for the first 24 hours
Time frame: the first 24 hours postoperative
Amount of total opioid consumption for 24 hours postoperative
2 secondary outcomes
Postoperative visual analogue scale (VAS)
Time frame: the second 24 hour postoperative
Amount of post operative opioid consumption for the second 24 hours
Time frame: the second 24 hour 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 21 Jul 2023.
- Derived from this study: PubMed 38344257Abu El Hassan SHA, Wahsh EA, Mousa AM, Ibrahim ARN, Mohammed EL. Comparative Study Between Dexmedetomidine with Bupivacaine and Bupivacaine Alone in Erector Spinae Plane Block for Postoperative Pain Control of Posterior Lumbosacral Spine Fixation Surgeries: A Randomized Controlled Trial. Drug Des Devel Ther. 2024 Feb 7;18:351-363. doi: 10.2147/DDDT.S444485. eCollection 2024.
- Individual participant dataSharing planned: No
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.
Abdelmaksod Mohammed M Mousa, MD principal investigator
October 6 University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dexmedetomidine injection, Bupivacaine 0.25% Injectable Solution and normal saline in people with Posterior Lumbosacral Spine Fixation Surgeries, run by October 6 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 3 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 21 Jul 2023. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Postoperative visual analogue scale (VAS) (time frame: the first 24 hours postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05590234, which also lists 1 linked publication.
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 21 Jul 2023.