Phase 4
N=89
the Analgesic Duration of Dexmedetomidine Compared to Dexamethasone as Adjuncts to Single Shot Interscalene Block
Opioid Use, Unspecified
Bottom Line
View on ClinicalTrials.gov: NCT02653144 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Opioid Requirements (Morphine Equivalents) — 15; 15; 22.5 morphine milligram equivalent
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ropivacaine (Drug); Dexmedetomidine (Drug); Dexamethasone (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Requirements (Morphine Equivalents) |
52.5; 30; 40 | — |
| SECONDARY Opioid Requirements (Morphine Equivalents) |
52.5; 30; 40 | — |
| SECONDARY Time to Discharge From PACU to First Opioid Consumption |
1280; 1130; 900 | — |
| SECONDARY Return of Motor and Sensory Function |
1280; 1130; 900 | — |
Summary
The purpose of the study is to determine if perineural dexmedetomidine can provide increased prolongation of analgesia when compared to perineural dexamethasone in patients receiving regional block for shoulder surgery. If so, dexmedetomidine may serve as a superior adjunct to peripheral nerve blocks in a rapidly evolving, ambulatory-centered surgical setting.
Eligibility Criteria
Inclusion Criteria
- ASA 1 and 2
- 18-60 years old
- Patients scheduled for ambulatory arthroscopic or open surgery
Exclusion Criteria
- ASA 3 and 4
- Pre-existing pain disorder
- Regular consumption of chronic pain medication
- Anatomical abnormalities of upper extremity
- Known allergy or hypersensitivity to Ropivacaine or other amide local anesthetics
- Known allergy to dexmedetomidine
- Coagulopathy
- Uncontrolled Diabetes
Data sourced from ClinicalTrials.gov (NCT02653144). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.