NCT05344495

Brief Summary

Comparing efficacy of hyalase and midazolam in median nerve entrapement neuropathy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2022

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2022

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

April 14, 2022

Last Update Submit

June 11, 2022

Conditions

Pain, Neuropathic

Outcome Measures

Primary Outcomes (1)

  • pain score

    visual analogue score which represents 0 = no pain, 10= worst un-imaginable pain

    6 months

Secondary Outcomes (3)

  • Boston questionnaire

    6 months

  • median nerve sonogrphy

    6 months

  • Nerve electrophysiology

    6 months

Study Arms (2)

hyalse group

ACTIVE COMPARATOR

ultrasonographic median nerve hydrodissection by hyalase and bupivacaine 0.5%

Drug: hyalase group

midazolam group

ACTIVE COMPARATOR

ultrasonographic median nerve hydrodissection by midazolam and bupivacaine 0.5%

Drug: midazolam group

Interventions

hyalase groupDRUG

bupivacaine 15 mg 0.5% plus 2 mL normal saline containing 300 international units (IU) hyaluronidase.

Also known as: Sonar guided median nerve hydrodissection by hyalase and bupivacaine 0.5%
hyalse group
midazolam groupDRUG

2 mg midazolam dissolved in 2 ml sterile saline plus 15 mg bupivacaine 0.5%

Also known as: Sonar guided median nerve hydrodissection by midazolam and bupivacaine 0.5%
midazolam group

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients (30 - 70 years old) complaining of carpal tunnel syndrome of 3 month duration or more , diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study refractory to medical treatment for 2 months .

You may not qualify if:

  • Diabetic patients
  • Pregnant population .
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mina Raouf

ALMinya, Minya Governorate, 6115, Egypt

RECRUITING

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and ICU

Study Record Dates

First Submitted

April 14, 2022

First Posted

April 25, 2022

Study Start

January 10, 2022

Primary Completion

July 20, 2022

Study Completion

August 1, 2022

Last Updated

June 15, 2022

Record last verified: 2022-06

Locations

EG(1)