NCT00825786

Brief Summary

This study will test the hypothesis that sequential injection of 1.5% mepivacaine followed 90 seconds later by 0.5% ropivacaine in ultrasound guided supraclavicular block provides a quicker onset and a longer duration of analgesia than an equi-dose mixture of the two local anesthetics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2008

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

September 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

April 19, 2017

Completed
Last Updated

June 14, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

January 16, 2009

Results QC Date

April 18, 2017

Last Update Submit

May 22, 2017

Conditions

Local Anesthetic

Keywords

surgery for arm hand or elbowmepivacaineropivacainehand surgeryelbow surgeryforearm surgery

Outcome Measures

Primary Outcomes (1)

  • Duration of Analgesia.

    The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.

    During surgery: postoperative day 0

Secondary Outcomes (6)

  • Time to Complete Motor Block

    during surgery from induction time to end case time

  • Time to Onset of First Sensory Block

    during surgery

  • Maximum Verbal Response Score (VRS) With Rest

    through post operative day 3

  • Maximum Verbal Response Score (VRS) With Movement

    through post operative day 3

  • Duration of Analgesia

    from surgery date to postoperative day 1

  • +1 more secondary outcomes

Study Arms (2)

Group 1

ACTIVE COMPARATOR

combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;

Drug: RopivacaineDrug: Mepivacaine

Group 2

ACTIVE COMPARATOR

sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.

Drug: RopivacaineDrug: Mepivacaine

Interventions

RopivacaineDRUG

ropivacaine (15 ml).

Group 1Group 2
MepivacaineDRUG

One syringe will contain mepivacaine (15 ml)

Group 1Group 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing upper extremity procedures suitable for supraclavicular anesthesia, including but not limited to oHand surgery oForearm surgery oElbow surgery
  • Age between 18 and 70 years

You may not qualify if:

  • Contraindications to supraclavicular block
  • Coagulopathy
  • Infection at the needle insertion site
  • Severe chronic obstructive pulmonary disease (COPD)
  • Contralateral pneumothorax or diaphragmatic paralysis
  • Pregnancy
  • Preexisting neuropathy involving the surgical limb
  • Routine opioid use
  • Inability to attain adequate ultrasound images in the supraclavicular area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

RopivacaineMepivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Priya Kumar, MD
Organization
University of North Carolina, Department of Anesthesiology, University of North Carolina
pkumar@aims.unc.edu,
(919) 966-5136

Study Officials

  • Michael R Ritchey, MD

    Cleveland Clinid

    PRINCIPAL INVESTIGATOR

  • Daniel I Sessler, MD

    The Cleveland Clinic

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2009

First Posted

January 21, 2009

Study Start

September 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

June 14, 2017

Results First Posted

April 19, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)