Effectiveness of Ultrasound (US) Guided Supraclavicular Block

NCT00923494 | Withdrawn DMC

• 1 other identifier: H-24506
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Analgesia; Pain

Keywords

Anesthesia

Outcome Measures

Primary Outcomes (2)

• Onset of analgesia

  First 30 minutes

• Duration of analgesia

  24 hours

Secondary Outcomes (1)

• Total analgesic use

  First 24 hours

Study Arms (3)

Group R20

ACTIVE COMPARATOR

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

Drug: 20 ml of ropivacaine 0.5%

Group R30

ACTIVE COMPARATOR

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

Drug: 30 ml of ropivacaine 0.5%

Group R40

ACTIVE COMPARATOR

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

Drug: 40 ml of ropivacaine 0.5%

Interventions

20 ml of ropivacaine 0.5% DRUG

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

Group R20

30 ml of ropivacaine 0.5% DRUG

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

Group R30

40 ml of ropivacaine 0.5% DRUG

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

Group R40

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Agnosia; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaime Ortiz, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 18, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

US (1)