Pain Clinical Trial
— SCB & IV DexOfficial title:
Intravenous Dexamethasone for Prolongation of Analgesia Following Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy: A Randomized, Controlled, Phase IV Dose-Response Study
NCT number | NCT02688530 |
Other study ID # | 2015-853 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | November 19, 2017 |
Verified date | May 2022 |
Source | Hospital for Special Surgery, New York |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Previous studies have confirmed that IV dexamethasone prolongs brachial plexus blocks. However, these studies only used fixed doses of IV dexamethasone at relatively high doses, which could potentially lead to increased glucose levels, delayed wound healing, and unintended side effects. There remains a paucity of research on the effective dose range of IV dexamethasone for the prolongation of supraclavicular blocks. The optimal dosage of IV dexamethasone for prolongation of analgesia vs. motor block prolongation from supraclavicular blocks in shoulder surgery has yet to be delineated.
Status | Completed |
Enrollment | 140 |
Est. completion date | November 19, 2017 |
Est. primary completion date | November 19, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Patients undergoing shoulder arthroscopy under regional anesthesia Exclusion Criteria: - General anesthesia - Contraindication to regional anesthesia - Pre-existing neuropathy in the surgical limb - Diabetes Mellitus - History of postoperative nausea and vomiting &/ or motion sickness - Procedures involving biceps tenotomy - Peri-articular cocktail injections given intraoperatively to augment pain relief - Chronic pain (daily opioid and/or gabapentinoid use for 6 weeks) - Open surgical procedures - Corticosteroid injection within 1 month - Patients on systemic oral or IV steroid therapy within 6 months |
Country | Name | City | State |
---|---|---|---|
United States | Hospital for Special Surgery | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Hospital for Special Surgery, New York |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy | Defined as time from block placement until "pain relief from the block completely wears off" in the operative shoulder. | Day of Surgery until Post-Operative Day 3 (if the block persists) | |
Secondary | Duration of Motor Block From the Supraclavicular Block | Defined as the time from block placement to restoration of normal strength at both the wrist and elbow. | Day of Surgery until Post-Operative Day 3 (if the block persists) | |
Secondary | Blood Glucose Levels | Fingerstick blood glucose test to be administered before and 1-hour and 2-hours after IV dexamethasone administration. | Day of Surgery - before and 1-hour and 2-hours after IV Dexamethasone administration | |
Secondary | Occurrence of Postoperative Neuropraxia | Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit. | Post-Operative Day 21 | |
Secondary | Occurrence of Postoperative Wound Infection | Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit. | Post-Operative Day 21 | |
Secondary | Average Daily Pain Scores at Rest and With Movement | Using the Numeric Rating Scale (NRS) Pain obtained by patient interview. Lower numbers represent less pain and better outcomes. The scale range is from 0 (no pain) to 10 (worst pain possible). | Day of Surgery until Post-Operative Day 3 (if the block persists) | |
Secondary | Worst Daily Pain Scores at Rest and With Movement | Using the numeric pain rating scale (NRS), will be obtained by patient interview. Lower numbers represent less pain and better outcomes. The scale range is from 0 (no pain) to 10 (worst pain possible). | Day of Surgery until Post-Operative Day 3 (if the block persists) | |
Secondary | Patient Satisfaction With Postoperative Analgesia | Patient satisfaction with postoperative analgesia will be obtained by patient interview. Lower numbers represent worse outcomes. The scale range is from 0 (worst) to 10 (best). | Post-Operative Day 2 or Post-Operative Day 3 (if the block persists) | |
Secondary | Cumulative Daily Opioid Usage | Dosages (reported in Morphine equivalent units) of opioid medication obtained by medical records and/or by patient interview. | Recovery Room until Post-Operative Day 3 (if block persists) |
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