NCT01719237

Brief Summary

A double blinded randomized controlled trial comparing the onset and duration of the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using a long acting local anesthestic (Ropivacaine) with a mixture of a long and short acting local anesthestic (Ropivacaine-Chloroprocaine Mixture).

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 phase_4 pain

Timeline
Completed

Started Aug 2009

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
9.9 years until next milestone

Results Posted

Study results publicly available

September 14, 2022

Completed
Last Updated

May 25, 2023

Status Verified

October 1, 2012

Enrollment Period

1.3 years

First QC Date

October 29, 2012

Results QC Date

August 19, 2022

Last Update Submit

May 23, 2023

Conditions

Keywords

OnsetDurationUpper Limb BlockUltrasound guided supraclavicular blockRopivacaineChloroprocaine

Outcome Measures

Primary Outcomes (1)

  • Onset of Surgical Anesthesia

    Onset of surgical anesthesia is defined as the time after injection of local anesthetic to the time where no sensation of pinprick in the ulnar, median, radial and musculocutaneous nerves

    45 minutes

Secondary Outcomes (1)

  • Duration of Analgesia

    72 hours

Study Arms (2)

Ropivacine and Cholroprocaine mixture

ACTIVE COMPARATOR

20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine

Drug: Ropivacine and Chloroprocaine mixture

Ropivacine only

SHAM COMPARATOR

30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's of normal saline + 0.1 ml of 1mg/ml epinephrine

Drug: Ropivacaine only

Interventions

Chloroprocaine is added to Ropivacaine

Ropivacine and Cholroprocaine mixture

Ropivacaine diluted with normal saline instead of chloroprocaine

Ropivacine only

Eligibility Criteria

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

You may not qualify if:

  • patients who are pregnant,
  • have an ASA status of IV or greater,
  • neuropathy,
  • a cast or other impediment to performing a motor or sensory exam in the arm and hand,
  • patients under the age of 18,
  • long term opioid therapy (longer than 1 month),
  • history of opioid abuse and pseudocholinesterase deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Nicholas Lam
Organization
University of New Mexico

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2012

First Posted

November 1, 2012

Study Start

August 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

May 25, 2023

Results First Posted

September 14, 2022

Record last verified: 2012-10

Locations