Phase 4
N=160
Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block
Anesthesia, Local
Bottom Line
View on ClinicalTrials.gov: NCT03117140 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Duration of Analgesia — 911; 1026.5; 1181; 982 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ropivacaine 0.75% (Drug); Ropivacaine 0.75% + 300 mcg Buprenorphine (Drug); Ropivacaine 0.75% + 75 mcg clonidine (Drug); Ropivacaine 0.75% + 8 mg dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Melinda Seering
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Analgesia |
911; 1026.5; 1181; 982 | — |
| SECONDARY Block Set up Time |
6; 3; 6; 4.5 | — |
| SECONDARY Sensory Duration of Block |
923.5; 982; 940.5; 1066 | — |
| SECONDARY Patient Reporting Vomiting at Home |
0; 3; 2; 1 | — |
| SECONDARY Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit) |
0; 1; 0; 0 | — |
| SECONDARY Number of Patients Reporting Nausea at Home |
4; 9; 2; 3 | — |
| SECONDARY Number of Patients Reporting Nausea in the PACU |
4; 9; 2; 9 | — |
| SECONDARY Motor Duration of Block |
1120; 1198; 1090; 1143.5 | — |
| SECONDARY Number of Patients With Blood Pressure (BP) Changes in the PACU |
8; 3; 7; 2 | — |
| SECONDARY Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area |
5; 1; 5; 0 | — |
| SECONDARY Pain Score Reported by Patients at First Phone Call |
4; 3; 4; 3 | — |
| SECONDARY Number of Patients Reporting Itching in the PACU |
5; 2; 6; 3 | — |
| SECONDARY Number of Patients Reporting Itching at Home |
1; 2; 2; 0 | — |
Summary
This is a prospective randomized controlled triple-masked study looking at the duration of nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and clonidine) plus ropivacaine versus plain ropivacaine alone.
Eligibility Criteria
Inclusion Criteria
- Patients who have or are:
- Orthopedics service patients having shoulder surgery
- ASA(American Society of Anesthesiologists) class I, II, or III.
- Patients at least 18 years old but less than 71 years old.
- Patients giving informed consent.
- Non-Emergency Surgery
Exclusion Criteria
- Patients who have or are:
- An inability to cooperate during the block placement.
- Neuropathy of the planned extremity to block
- Diabetes
- Documented Kidney Disease
- Documented Liver Disease
- A lack of or inability to give informed consent.
- Currently incarcerated.
- Pregnant
Data sourced from ClinicalTrials.gov (NCT03117140). 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.