Distal Radius Fracture Clinical Trial
Official title:
Comparison Between Single Shot Versus Continuous Infraclavicular Brachial Plexus Block for Postoperative Analgesia After Distal Radius Fracture: A Prospective Randomized Open Label Study
NCT number | NCT02744352 |
Other study ID # | 823323 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | October 5, 2018 |
Verified date | March 2020 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare infraclavicular brachial plexus shot single shot block to continuous catheter nerve block done in adult patients who have under gone surgery to repair distal radius fractures. Visual analogue scores, opioid consumption, quality of recovery and quality of sleep up to 72 hours post operatively will be used for comparison.
Status | Terminated |
Enrollment | 8 |
Est. completion date | October 5, 2018 |
Est. primary completion date | October 5, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients scheduled for open reduction and internal fixation of a distal radius fracture - American Society of Anesthesiologists (ASA) physical status I -III - Mentally competent and able to give consent for enrollment in the study Exclusion Criteria: - Patient younger than 18 years old - Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone and any of the drugs included in the standard of care - Patients opting to go under general anesthesia and those refusing the block - Chronic pain syndromes; Patients will be defined to have chronic pain if they are using regular daily doses of systemic narcotics for the past 6 months prior to the surgery - BMI of 40 or more |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Scores as Measured by the Visual Analog Scale | Pain scores at rest and with movement. | 72 hours | |
Primary | Participants Need for Pain Relief as Measured by Opiate Consumption | Amount of opiate consumption | 72 hours | |
Secondary | Quality of Recovery Score | Score of QoR survey to determine recovery status | 72 hours | |
Secondary | Number of Subjects With Insomnia as Measured by Sleep Questionnaire | Quality of sleep first 2 nights post surgery | 48 hours | |
Secondary | Range of Motion as Measured by the Disability Assessment of Shoulder and Hand Questionnaire | Dash questionnaire to measure range of motion of the wrist and fingers 3 months after surgery | 3 months |
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