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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00923494
Other study ID # H-24506
Secondary ID
Status Withdrawn
Phase N/A
First received June 16, 2009
Last updated January 19, 2017
Start date May 2009
Est. completion date December 2010

Study information

Verified date January 2017
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
20 ml of ropivacaine 0.5%
Patient will receive 20 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.
30 ml of ropivacaine 0.5%
Patient will receive 30 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.
40 ml of ropivacaine 0.5%
Patient will receive 40 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.

Locations

Country Name City State
United States Ben Taub General Hospital Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Onset of analgesia First 30 minutes
Primary Duration of analgesia 24 hours
Secondary Total analgesic use First 24 hours
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