This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Effectiveness of Ultrasound (US) Guided Supraclavicular Block

This study has been withdrawn prior to enrollment.
(Unable to enroll. Change in patient population.)
Sponsor:
Information provided by (Responsible Party):
Jaime Ortiz, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00923494
First received: June 16, 2009
Last updated: January 19, 2017
Last verified: January 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant
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:


Further study details as provided by Jaime Ortiz, Baylor College of Medicine:

Primary Outcome Measures:
  • Onset of analgesia [ Time Frame: First 30 minutes ]
  • Duration of analgesia [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Total analgesic use [ Time Frame: First 24 hours ]

Enrollment: 0
Actual Study Start Date: May 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: January 19, 2017

Keywords provided by Jaime Ortiz, Baylor College of Medicine:
Anesthesia

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

ClinicalTrials.gov processed this record on July 21, 2017