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WithdrawnNCT00923494Updated Jan 20, 2017

Effectiveness of Ultrasound (US) Guided Supraclavicular Block

An interventional study of 20 ml of ropivacaine 0.5% and 30 ml of ropivacaine 0.5% in Analgesia and Pain, sponsored by Baylor College of Medicine. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2017-01-20.

Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Unable to enroll. Change in patient population.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Analgesia
  • Pain

Keywords

  • Anesthesia
03

In context

Lead sponsor

Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • 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%

  • 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%

  • 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%

Interventions

  • Drug20 ml of ropivacaine 0.5%

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

  • Drug30 ml of ropivacaine 0.5%

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

  • Drug40 ml of ropivacaine 0.5%

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

06

What researchers measure

Primary outcomes

  1. Onset of analgesia

    Time frame: First 30 minutes

  2. Duration of analgesia

    Time frame: 24 hours

Secondary outcomes

  1. Total analgesic use

    Time frame: First 24 hours

07

Study locations

1 site
  • Ben Taub General Hospital
    Houston, Texas 77030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00923494
Lead sponsor
Baylor College of Medicine
Responsible party
Jaime Ortiz (Assistant Professor of Anesthesiology, Baylor College of Medicine) — Principal investigator
First posted
Jun 18, 2009
Start date
May 2009
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Jan 20, 2017

Study contacts

Jaime Ortiz, MD
principal investigator · Baylor College of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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