NCT00523289

Brief Summary

The purpose of this study is to determine if bupivacaine (75% levobupivacaine plus 25% racemic bupivacaine) with vasoconstrictor is effective and safety as ropivacaine in brachial plexus block for orthopedic surgery.

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
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2007

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

First Submitted

Initial submission to the registry

August 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

February 19, 2009

Status Verified

February 1, 2009

Enrollment Period

1.4 years

First QC Date

August 29, 2007

Last Update Submit

February 18, 2009

Conditions

Injuries, HandAnesthesia ConductionAnesthetics, Local

Keywords

RopivacaineBupivacaineUpper ExtremityLocal anesthetic

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular safety

    Two days

Secondary Outcomes (1)

  • Anesthesia Analgesia quality

    Two days

Study Arms (2)

B

ACTIVE COMPARATOR

Arm number B corresponds to the Bupivacaine group.

Drug: Bupivacaine

R

ACTIVE COMPARATOR

Arm number R corresponds to the Ropivacaine group.

Drug: Ropivacaine

Interventions

BupivacaineDRUG

Dosage: 150mg at once for anesthesia induction

B
RopivacaineDRUG

Single dose of ropivacaine, 150mg

R

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients involved: 48; ASA I and II;
  • Surgery: elective upper extremity orthopedic surgery.

You may not qualify if:

  • Contraindications to anesthesia technique and/or to local anesthetic;
  • Participation in different trials in the last two months;
  • Antiretroviral users;
  • Obesity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Casati A, Santorsola R, Aldegheri G, Ravasi F, Fanelli G, Berti M, Fraschini G, Torri G. Intraoperative epidural anesthesia and postoperative analgesia with levobupivacaine for major orthopedic surgery: a double-blind, randomized comparison of racemic bupivacaine and ropivacaine. J Clin Anesth. 2003 Mar;15(2):126-31. doi: 10.1016/s0952-8180(02)00513-5.

    PMID: 12719052BACKGROUND

  • Casati A, Chelly JE, Cerchierini E, Santorsola R, Nobili F, Grispigni C, Di Benedetto P, Torri G. Clinical properties of levobupivacaine or racemic bupivacaine for sciatic nerve block. J Clin Anesth. 2002 Mar;14(2):111-4. doi: 10.1016/s0952-8180(01)00364-6.

    PMID: 11943523BACKGROUND

  • Casati A, Borghi B, Fanelli G, Montone N, Rotini R, Fraschini G, Vinciguerra F, Torri G, Chelly J. Interscalene brachial plexus anesthesia and analgesia for open shoulder surgery: a randomized, double-blinded comparison between levobupivacaine and ropivacaine. Anesth Analg. 2003 Jan;96(1):253-9, table of contents. doi: 10.1097/00000539-200301000-00051.

    PMID: 12505962BACKGROUND

  • Santorsola R, Casati A, Cerchierini E, Moizo E, Fanelli G. [Levobupivacaine for peripheral blocks of the lower limb: a clinical comparison with bupivacaine and ropivacaine]. Minerva Anestesiol. 2001 Sep;67(9 Suppl 1):33-6. Italian.

    PMID: 11778092BACKGROUND

  • Borgeat A, Ekatodramis G, Blumenthal S. Interscalene brachial plexus anesthesia with ropivacaine 5 mg/mL and bupivacaine 5 mg/mL: effects on electrocardiogram. Reg Anesth Pain Med. 2004 Nov-Dec;29(6):557-63. doi: 10.1016/j.rapm.2004.09.005.

    PMID: 15635515BACKGROUND

MeSH Terms

Conditions

Hand Injuries

Interventions

BupivacaineRopivacaine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • José Otávio C Auler Junior, PhD/Chairman

    Hospital das Clínicas - Medicine School of the University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2007

First Posted

August 31, 2007

Study Start

October 1, 2007

Primary Completion

March 1, 2009

Study Completion

July 1, 2009

Last Updated

February 19, 2009

Record last verified: 2009-02