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Effectiveness of Ultrasound (US) Guided Supraclavicular Block

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Jaime Ortiz, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00923494
First received: June 16, 2009
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

This research study is being done in order to find out if there is any difference in the effectiveness of ultrasound guided supraclavicular brachial plexus nerve block that can be achieved with 3 different amounts of ropivacaine 0.5% (20 ml, 30 ml, and 40 ml). The investigators want to show if you can have a successful nerve block with less amount of local anesthetic, thus potentially decreasing the risk of side effects.


Condition Intervention
Analgesia
Pain
 Drug: 20 ml of ropivacaine 0.5%
Drug: 30 ml of ropivacaine 0.5%
Drug: 40 ml of ropivacaine 0.5%

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effectiveness of Ultrasound Guided Supraclavicular Brachial Plexus Block With 20, 30, or 40 ml of Ropivacaine 0.5%

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Onset of analgesia [ Time Frame: First 30 minutes ] [ Designated as safety issue: No ]
  • Duration of analgesia [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total analgesic use [ Time Frame: First 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group R20
Patient will receive 20 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.
 Drug: 20 ml of ropivacaine 0.5%
Patient will receive 20 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.
Active Comparator: Group R30
Patient will receive 30 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.
 Drug: 30 ml of ropivacaine 0.5%
Patient will receive 30 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.
Active Comparator: Group R40
Patient will receive 40 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.
 Drug: 40 ml of ropivacaine 0.5%
Patient will receive 40 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between the ages of 18-64,
  • Patients who are ASA I-III, presenting for distal upper extremity surgery. Surgeries to be considered are ORIF of distal upper extremity fractures such as ORIF radius, ORIF ulna, ORIF of any bones in the wrist or hand, and distal upper extremity surgery involving bones or tendons for which postoperative pain is to be expected. No emergency surgeries will be considered.

Exclusion Criteria:

  • Emergency surgery,
  • Patient or surgeon refusal
  • Patients for which peripheral nerve block or study medications are contraindicated,
  • Patients on chronic analgesic therapy at home,
  • History of nerve injury, neuropathy, or known neurologic injury or illness, or inability to properly describe postoperative pain to investigators (language barrier, psychiatric disorder, dementia).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923494

Locations
United States, Texas
Ben Taub General Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Jaime Ortiz, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Jaime Ortiz, Assistant Professor of Anesthesiology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00923494     History of Changes
Other Study ID Numbers: H-24506
Study First Received: June 16, 2009
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Anesthesia

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013