Wrist Injuries Clinical Trial
Official title:
Comparison Between Infraclavicular Brachial Plexus Block Versus Local Infiltration for Postoperative Analgesia After Wrist Arthroscopy, a Prospective Randomized Open Label Study
NCT number | NCT02970097 |
Other study ID # | 825465 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | October 5, 2018 |
Verified date | February 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 local infiltration done in adult patients having wrist arthroscopy surgery. Visual analogue scores, opioid consumption, quality of recovery and quality of sleep up to 72 hours post operatively will be used for comparison.
Status | Withdrawn |
Enrollment | 0 |
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 wrist arthroscopy - 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 light 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 | 7 days | |
Secondary | quality of sleep as measured by modified Pittsburgh Sleep Quality Index | a 9-question survey in which patients report how often sleep-related problems occur on a scale of 0 to 3 | 72 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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