NCT05280223

Brief Summary

Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy, this study aims to investigate if, and to what extent hydro-dissection hyalase and saline versus dexmedetomidine upon the median nerve could offer symptoms and clinical improvement

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

March 6, 2022

Last Update Submit

October 30, 2023

Conditions

Carpal Tunnel SyndromePain, Chronic

Outcome Measures

Primary Outcomes (1)

  • Pain alleviation

    pain alleviation improvement of pain measured by visual analog scale , no pain the scale equal zero , and worst pain the scale equal 10

    6 months

Secondary Outcomes (1)

  • Median nerve cross sectional area

    6 months

Study Arms (2)

Dexmeditomidine group

ACTIVE COMPARATOR

injection of 1 microgram/kg dexmedetomidine + 10 cc saline injection nearby median nerve as hydrodissection

Drug: Dexmedetomidine

Hyalase

ACTIVE COMPARATOR

injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection

Drug: Hyalase

Interventions

DexmedetomidineDRUG

injection of 1 microgram/kg dexmeditomidine + 10 cc saline injection nearby median nerve as hydrodissection

Dexmeditomidine group
HyalaseDRUG

injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection

Hyalase

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • adult patients
  • complaining of carpal tunnel syndrome of 3 month duration or more
  • diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study

You may not qualify if:

  • patient refusal infection at the site of intervention
  • local anesthetic allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel SyndromeChronic Pain

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 6, 2022

First Posted

March 15, 2022

Study Start

April 1, 2022

Primary Completion

June 30, 2023

Study Completion

August 25, 2023

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)