Analgesia Clinical Trial
Official title:
Comparison of the Effects of Different Time of Intravenous Dexamethasone on Brachial Plexus Block: a Randomized Control Study
Verified date | January 2023 |
Source | Shanghai Jiao Tong University Affiliated Sixth People's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Dexamethasone has been tested as an effective adjuvant to prolong the effect of local anesthetics for peripheral nerve blocks, both perineurally and intravenously. The purpose of this study is to investigate the effect of the addition of dexamethasone (5mg) at different time to a standard ropivacaine solution (0.5%) on analgesic duration of interscalene block.
Status | Completed |
Enrollment | 180 |
Est. completion date | July 31, 2021 |
Est. primary completion date | May 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Patients undergoing arthroscopic shoulder surgery at Shanghai Sixth People's Hospital. - ASA functional status class I to II - Age 18 to 70 years - BMI = 35 kg/m2 Exclusion Criteria: 1. Lack of patient consent 2. Allergy to dexamethasone or ropivacaine 3. BMI > 35 kg/m2 4. Contraindications to low dose dexamethasone including peptic ulcer disease, systemic infection, glaucoma, active varicella/herpetic infections, diabetes mellitus 5. Contraindications to ISB including severe Chronic Obstructive Pulmonary Disease (Forced expiratory volume < 40% predicted), coagulopathy, pre-existing neurologic deficit in ipsilateral upper extremity, localized infection 6. Pregnant or nursing females 7. Chronic opioid use defined as > 30mg oral morphine or equivalent per day |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Jiao Tong University Affiliated Sixth People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of sensory block | from completion of ISB to VAS for pain > 0 ( in hours) | one day postoperative | |
Secondary | Time to First Opioid Consumption | Time from completion of block procedure to first consumption of opioid analgesic (in hours) | one day postoperative | |
Secondary | Opioid Consumption | Opioid consumption (in oral morphine equivalents) will be recorded at 12 hours, 24 hours and 48 hours | two days postoperative | |
Secondary | Visual Analog Scale for pain ( from 0 to 10 ) | Recorded at 12 hours, 24 hours, and 7 days 0 is no pain, 10 is the worst pain imaginable. Lower number is better. | 7 days postoperative | |
Secondary | Postoperative Serum Blood Glucose | Measured on the morning of first day after surgery | one day postoperative | |
Secondary | Infection | Number of participants with localized infection at nerve block site | 7 days postoperative | |
Secondary | Number of Participants With Postoperative Nausea and/or Vomiting | Number of participants with postoperative nausea and/or vomiting assessed at 12 hours, 24, hours, and 7 days postoperatively | 7 days postoperative | |
Secondary | Number of Participants With Nerve Damage From Interscalene Block | Persistent paresthesia, and sensory/motor block at 7 days | 7 days postoperative |
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