Pain, PostoperativeNCT06685081
Dexmedetomidine for Improved Pain Relief and Recovery in Spine Surgery
A study testing Dexmedetomidine and lidocaine and triamcinolone in people with Pain, Postoperative, run by Menoufia University at 1 site in Egypt.
Trial summary
Chronic low back pain (CLBP) is a prevalent condition causing significant pain, disability, and reduced quality of life. While various treatments like exercise, NSAIDs, and spinal manipulation are recommended, their effectiveness is limited. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Dexmedetomidine and lidocaine and triamcinolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Nov 2024
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who had Chronic Lower Back pain defined as persistent pain for more than 6 weeks with manifest affection of daily activities;
- Patients who had Chronic Lower Back pain defined as persistent pain for more than 6 weeks with manifest affection of quality of walking and life;
- Patients who had Chronic Lower Back pain defined as persistent pain for more than 6 weeks maintained on systemic analgesics;
- Patients who were free of exclusion criteria were enrolled in the study.
Who cannot join
- The presence of osteolytic vertebral lesions;
- The Presence of previous surgical intervention;
- The presence of allergy to the studied drugs;
- Patients of ASA grade >II.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal-dose of Dexmedetomidine as Adjuvant to Epidural Local Anesthetic/Steroid Injectate to Improve Pain and Quality of Waking in Patients With Chronic Low Back Pain: A Randomized Case-control Study
Chronic low back pain (CLBP) is a prevalent condition causing significant pain, disability, and reduced quality of life. While various treatments like exercise, NSAIDs, and spinal manipulation are recommended, their effectiveness is limited. Epidural steroid injections can provide short-term relief but may not be cost-effective and have associated risks.
Dexmedetomidine (DXM) is a selective α2-adrenergic agonist with analgesic properties. It has been used as an adjuvant to anesthetics and analgesics to enhance pain relief and reduce opioid consumption. Using DXM in conjunction with local anesthetics for regional blocks has shown promising results in improving analgesia and functional outcomes.
- Conditions
- Pain, Postoperative
- Being tested
- Dexmedetomidine, lidocaine and triamcinolone
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine was injected in dose of 0.25 µg/kg
DexmedetomidineDrug
Dexmedetomidine was injected in dose of 0.5 µg/kg
DexmedetomidineDrug
Dexmedetomidine was injected in dose of 0.75 µg/kg
DexmedetomidineDrug
Dexmedetomidine was injected in dose of 1 µg/kg
lidocaine and triamcinoloneDrug
2 ml of 1.5% lidocaine and 2 ml of triamcinolone was mixed and provided to all patients as epidural injection
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Not described Receives: Drug: lidocaine and triamcinolone |
| Group II | Active comparator | Not described Receives: Drug: Dexmedetomidine; Drug: lidocaine and triamcinolone |
| Group III | Active comparator | Not described Receives: Drug: Dexmedetomidine; Drug: lidocaine and triamcinolone |
| Group IV | Active comparator | Not described Receives: Drug: Dexmedetomidine; Drug: lidocaine and triamcinolone |
| Group V | Active comparator | Not described Receives: Drug: Dexmedetomidine; Drug: lidocaine and triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) in post-Operative Follow up for Spine Surgery.
Value of Dexmedetomidine injection in Pain Reduction post operatively manifested by recurrence of pain.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Jul 2024
- Primary completion15 Oct 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Helwa, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685081
- Sponsor's protocol ID
- 7-2024ANST5
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal-dose of Dexmedetomidine as Adjuvant to Epidural Local Anesthetic/Steroid Injectate to Improve Pain and Quality of Waking in Patients With Chronic Low Back Pain: A Randomized Case-control Study
- ClinicalTrials.gov ID
- NCT06685081
- Acronym / sponsor ID
- 7-2024ANST5
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 12 Nov 2024 (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.
Chronic low back pain (CLBP) is a prevalent condition causing significant pain, disability, and reduced quality of life. While various treatments like exercise, NSAIDs, and spinal manipulation are recommended, their effectiveness is limited. Epidural steroid injections can provide short-term relief but may not be cost-effective and have associated risks.
Dexmedetomidine (DXM) is a selective α2-adrenergic agonist with analgesic properties. It has been used as an adjuvant to anesthetics and analgesics to enhance pain relief and reduce opioid consumption. Using DXM in conjunction with local anesthetics for regional blocks has shown promising results in improving analgesia and functional outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: lidocaine and triamcinolone |
| Group II | Active comparator | Drug: Dexmedetomidine, Drug: lidocaine and triamcinolone |
| Group III | Active comparator | Drug: Dexmedetomidine, Drug: lidocaine and triamcinolone |
| Group IV | Active comparator | Drug: Dexmedetomidine, Drug: lidocaine and triamcinolone |
| Group V | Active comparator | Drug: Dexmedetomidine, Drug: lidocaine and triamcinolone |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who had Chronic Lower Back pain defined as persistent pain for more than 6 weeks with manifest affection of daily activities;
- Patients who had Chronic Lower Back pain defined as persistent pain for more than 6 weeks with manifest affection of quality of walking and life;
- Patients who had Chronic Lower Back pain defined as persistent pain for more than 6 weeks maintained on systemic analgesics;
- Patients who were free of exclusion criteria were enrolled in the study.
Key exclusion criteria (4 listed)
- The presence of osteolytic vertebral lesions;
- The Presence of previous surgical intervention;
- The presence of allergy to the studied drugs;
- Patients of ASA grade >II.
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 |
|---|---|---|
| DexmedetomidineDexmedetomidine was injected in dose of 0.25 µg/kg | Drug | Group II |
| DexmedetomidineDexmedetomidine was injected in dose of 0.5 µg/kg | Drug | Group III |
| DexmedetomidineDexmedetomidine was injected in dose of 0.75 µg/kg | Drug | Group IV |
| DexmedetomidineDexmedetomidine was injected in dose of 1 µg/kg | Drug | Group V |
| lidocaine and triamcinolone2 ml of 1.5% lidocaine and 2 ml of triamcinolone was mixed and provided to all patients as epidural injection | Drug | Group I, Group II, Group III, Group IV, Group V |
Primary outcome
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) in post-Operative Follow up for Spine Surgery.
Time frame: 3 months
Value of Dexmedetomidine injection in Pain Reduction post operatively manifested by recurrence of pain.
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 12 Nov 2024.
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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 Dexmedetomidine and lidocaine and triamcinolone in people with Pain, Postoperative, run by Menoufia 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 4 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 12 Nov 2024. 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?
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?
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) in post-Operative Follow up for Spine Surgery. (time frame: 3 months). 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 12 Nov 2024.