Pain SyndromeNCT04527770
Midazolam Versus Dexamethasone as an Adjuvant to Local Anesthetics in the Ultrasound Guided Hydrodissection of Median Nerve for Treatment of Carpal Tunnel Syndrome Patients
A study testing Dexamethasone and Midazolam injection in people with Pain Syndrome, run by Minia University at 1 site in Egypt.
Trial summary
midazolam and dexamethasone both can counteract chronic pain. either via GABA mimetic action or via anti prostaglandins Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Pain Syndrome
- What is being tested?
- Dexamethasone and Midazolam injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 30 Apr 2021
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- numbness or pain in the nerve distribution, nerve conduction studies (NCS) corresponding with AANEM guidelines
- Nerve cross sectional area >12mm2
Who cannot join
- Refusal to participate
- History of operation in median nerve.were patient refusal to participate, pain recurrence after previous injection and severe symptoms requiring surgical release, diabetic patients
Trial locations and contacts
1 site in 1 country.
About this study
midazolam and dexamethasone both can counteract chronic pain. either via GABA mimetic action or via anti prostaglandins
Read the detailed description
Entrapement syndrome - namely median nerve compression in carpal tunnel syndrome - causes chronic pain that can be refractory to medical treatment . Ultrasound guided hydrodissection is an option for alleviating pain . Recurrence is the main side effect of injection. We try in this research to prevent recurrence rate . Midazolam and dexamethasone both are used in chronic pain . Midazolm act by GABA mimetic action while dexamethasone act by decrease interleukin formation
- Conditions
- Pain Syndrome
- Being tested
- Dexamethasone, Midazolam injection
- Keywords
- Midazolam, median nerve, dexamethasone
- Medical subject headings
- Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called midazolam
Ultrasound guided median nerve hydrodiseection using dexamethasone or midazolam
Midazolam injectionDrug
intracarpal injection of midazolam and bupivacaine 0.5%
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone group | Active comparator | sonar guided median nerve hydrodissection by bupivacaine 0.5% and dexamethasone Receives: Drug: Dexamethasone |
| midazolam group | Active comparator | sonar guided median nerve hydrodissection by bupivacaine 0.5% and midazolam Receives: Drug: Midazolam injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing efficacy of midazolam against dexmethasone in combination with bupivacaine 0.5%
use of visual analogue score
Measured: up to 6 months
Secondary outcomes (4)
Subjective pain assesment
BOSTON questionnaire
Measured: up to 6 months
complications
neurotoxicity, pain recurrence after injection
Measured: pain recurrence after 6 months, neurotoxicity immediately after injection
Nerve electrophysiology
sensory nerve conduction , distal motor latency.
Measured: up to 6 months
nerve sonogram
nerve cross sectional area.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Sep 2020
- Primary completion1 Mar 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Minia 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
- Model description
- 2 groups received hydrodissection sonar guided , one group received 50 mic/kg midazolam and the other received 8 mg dexamethasone
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Maher, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527770
- Sponsor's protocol ID
- 644/4-2020
- Status last verified
- Feb 2022
- First submitted
- 23 Aug 2020
- Last updated
- 18 Feb 2022
- 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 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midazolam Versus Dexamethasone as an Adjuvant to Local Anesthetics in the Ultrasound Guided Hydrodissection of Median Nerve for Treatment of Carpal Tunnel Syndrome Patients
- ClinicalTrials.gov ID
- NCT04527770
- Acronym / sponsor ID
- 644/4-2020
- Conditions
- Pain Syndrome
- Keywords
- Midazolam, median nerve, dexamethasone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 27 Aug 2020 (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.
midazolam and dexamethasone both can counteract chronic pain. either via GABA mimetic action or via anti prostaglandins
Detailed description
Entrapement syndrome - namely median nerve compression in carpal tunnel syndrome - causes chronic pain that can be refractory to medical treatment . Ultrasound guided hydrodissection is an option for alleviating pain . Recurrence is the main side effect of injection. We try in this research to prevent recurrence rate . Midazolam and dexamethasone both are used in chronic pain . Midazolm act by GABA mimetic action while dexamethasone act by decrease interleukin formation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 2 groups received hydrodissection sonar guided , one group received 50 mic/kg midazolam and the other received 8 mg dexamethasone
| Arm | Type | Receives |
|---|---|---|
| dexamethasone group | Active comparator | Drug: Dexamethasonesonar guided median nerve hydrodissection by bupivacaine 0.5% and dexamethasone |
| midazolam group | Active comparator | Drug: Midazolam injectionsonar guided median nerve hydrodissection by bupivacaine 0.5% and midazolam |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- numbness or pain in the nerve distribution, nerve conduction studies (NCS) corresponding with AANEM guidelines
- Nerve cross sectional area >12mm2
Key exclusion criteria (2 listed)
- Refusal to participate
- History of operation in median nerve.were patient refusal to participate, pain recurrence after previous injection and severe symptoms requiring surgical release, diabetic patients
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 |
|---|---|---|
| DexamethasoneAlso: midazolamUltrasound guided median nerve hydrodiseection using dexamethasone or midazolam | Drug | dexamethasone group |
| Midazolam injectionintracarpal injection of midazolam and bupivacaine 0.5% | Drug | midazolam group |
Primary outcome
comparing efficacy of midazolam against dexmethasone in combination with bupivacaine 0.5%
Time frame: up to 6 months
use of visual analogue score
4 secondary outcomes
Subjective pain assesment
Time frame: up to 6 months
complications
Time frame: pain recurrence after 6 months, neurotoxicity immediately after injection
Nerve electrophysiology
Time frame: up to 6 months
nerve sonogram
Time frame: up to 6 months
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 18 Feb 2022.
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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 Dexamethasone and Midazolam injection in people with Pain Syndrome, run by Minia 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 2 inclusion and 2 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 18 Feb 2022. 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?
comparing efficacy of midazolam against dexmethasone in combination with bupivacaine 0.5% (time frame: up to 6 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 18 Feb 2022.