NCT03117140

Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block

A Prospective Triple-masked Randomized Controlled Trial Measuring Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Melinda Seering · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. This will be looked on on patients undergoing painful shoulder surgery in the ambulatory surgery center. Patients will be randomized to one of four groups (1. 0.75% plain ropivacaine. The reference comparator 2. A mixture of 0.75% ropivacaine with 300 mcg buprenorphine 3. A mixture of 0.75% ropivacaine with 75 mcg clonidine 4. A mixture of 0.75% ropivacaine with and 8mg dexamethasone) for their regimen in the interscalene block for their surgery. The patients will then be called within 3 days post-operatively to follow-up. Follow-up data collected will be when did the patient experience return of pain to the operative limb (duration of analgesia), when did the patient experience return of motor function of the operative limb (duration of motor block) and when did the patient experience return of sensation of the operative limb (return of sensory block). All three of these adjuvants have been studied previously and shown to have increased analgesic duration with local anesthesia, but have never had a good comparative study. The mechanism of action of the analgesia for these adjuvants pain relief has never been shown although it is likely a indirect effect as there are animal studies looking at their effect on A and C fibers that did not show those results.

Conditions

• Anesthesia, Local

Interventions

Type	Name	Description
DRUG	Ropivacaine 0.75%	Only ropivacaine 0.75% is administered for this arm of the interscalene block
DRUG	Ropivacaine 0.75% + 300 mcg Buprenorphine	Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
DRUG	Ropivacaine 0.75% + 75 mcg clonidine	Ropivacaine 0.75% + 75 mcg Clonidine is administered for this arm of the interscalene block
DRUG	Ropivacaine 0.75% + 8 mg dexamethasone	Ropivacaine 0.75% + 8 mg Dexamethasone is administered for this arm of the interscalene block

Timeline

• Start date: 2013-12-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2017-04-17
• Last updated: 2018-07-03
• Results posted: 2018-07-03

Locations

1 site across 1 country: United States