NCT06389617

Brief Summary

To compare the analgesic properties of ultrasound guided supraclavicular block using ropivacaine 0.5% in arteriovenous fistula creation when used in combination with intravenous administered dexamethasone at 4mg and 8 mg as an adjuvant

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

April 24, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

April 24, 2024

Last Update Submit

April 24, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • To compare the difference of onset time between sensory and motor block of supraclavicular block between ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg

    2 days

  • To compare the difference in duration of analgesia between supraclavicular block with ropivacaine and IV dexamethasone 4mg with ropivacaine and IV dexamethasone 8mg

    2 days

Secondary Outcomes (1)

  • To compare the duration difference of the return of motor block between supraclavicular block using ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg

    2 days

Study Arms (2)

GROUP DF

ACTIVE COMPARATOR

supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous dexamethasone 4mg

Drug: supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasone

GROUP DE

ACTIVE COMPARATOR

supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous dexamethasone 8mg

Drug: supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasone

Interventions

Comparing the onset of sensory, motor block, duration of motor block and analgesic duration

GROUP DEGROUP DF

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult, age 18 to 65 years End stage renal disease patients for AV fistula creation

You may not qualify if:

  • Not suitable candidate as determined by the primary team Refusal for brachial plexus block History of allergy to dexamethasone or local anesthesia Pregnancy History of previous brachial plexus injury Coagulopathy Local skin site infection Known neuropathy involving the arm undergoing surgery Patients with glucose reading more then 12mmol/

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 24, 2024

First Posted

April 29, 2024

Study Start

May 1, 2024

Primary Completion

November 30, 2024

Study Completion

December 30, 2024

Last Updated

April 29, 2024

Record last verified: 2024-04