Back to resultsMidazolam Versus Dexamethasone as an Adjuvant to Local Anesthetics in the Ultrasound Guided Hydrodissection of Median Nerve for Treatment of Carpal Tunnel Syndrome Patients
Primary Purpose
Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexamethasone
Midazolam injection
Sponsored by
About this trial
This is an interventional treatment trial for Pain Syndrome focused on measuring Midazolam, median nerve, dexamethasone
Eligibility Criteria
Inclusion Criteria:
- numbness or pain in the nerve distribution, nerve conduction studies (NCS) corresponding with AANEM guidelines
- Nerve cross sectional area >12mm2
Exclusion Criteria:
- 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
Sites / Locations
- Mina Maher Raouf
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
dexamethasone group
midazolam group
Arm Description
sonar guided median nerve hydrodissection by bupivacaine 0.5% and dexamethasone
sonar guided median nerve hydrodissection by bupivacaine 0.5% and midazolam
Outcomes
Primary Outcome Measures
comparing efficacy of midazolam against dexmethasone in combination with bupivacaine 0.5%
use of visual analogue score
Secondary Outcome Measures
Subjective pain assesment
BOSTON questionnaire
complications
neurotoxicity, pain recurrence after injection
Nerve electrophysiology
sensory nerve conduction , distal motor latency.
nerve sonogram
nerve cross sectional area.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04527770
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Syndrome
Keywords
Midazolam, median nerve, dexamethasone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups received hydrodissection sonar guided , one group received 50 mic/kg midazolam and the other received 8 mg dexamethasone
Masking
ParticipantInvestigator
Masking Description
both drugs are the same colour and volume injected by a staff member not aware of study design
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dexamethasone group
Arm Type
Active Comparator
Arm Description
sonar guided median nerve hydrodissection by bupivacaine 0.5% and dexamethasone
Arm Title
midazolam group
Arm Type
Active Comparator
Arm Description
sonar guided median nerve hydrodissection by bupivacaine 0.5% and midazolam
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
midazolam
Intervention Description
Ultrasound guided median nerve hydrodiseection using dexamethasone or midazolam
Intervention Type
Drug
Intervention Name(s)
Midazolam injection
Intervention Description
intracarpal injection of midazolam and bupivacaine 0.5%
Primary Outcome Measure Information:
Title
comparing efficacy of midazolam against dexmethasone in combination with bupivacaine 0.5%
Description
use of visual analogue score
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Subjective pain assesment
Description
BOSTON questionnaire
Time Frame
up to 6 months
Title
complications
Description
neurotoxicity, pain recurrence after injection
Time Frame
pain recurrence after 6 months, neurotoxicity immediately after injection
Title
Nerve electrophysiology
Description
sensory nerve conduction , distal motor latency.
Time Frame
up to 6 months
Title
nerve sonogram
Description
nerve cross sectional area.
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
numbness or pain in the nerve distribution, nerve conduction studies (NCS) corresponding with AANEM guidelines
Nerve cross sectional area >12mm2
Exclusion Criteria:
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
Facility Information:
Facility Name
Mina Maher Raouf
City
ALMinya
ZIP/Postal Code
6115
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Midazolam Versus Dexamethasone as an Adjuvant to Local Anesthetics in the Ultrasound Guided Hydrodissection of Median Nerve for Treatment of Carpal Tunnel Syndrome Patients
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