Skip to main content
Clinical Trials/NCT03117140
NCT03117140CompletedPhase 4

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

Melinda Seering1 site in 1 country160 target enrollmentStarted: December 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
160
Locations
1
Primary Endpoint
Duration of Analgesia

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • Documented Kidney Disease
  • Documented Liver Disease
  • A lack of or inability to give informed consent.
  • Currently incarcerated.

Arms & Interventions

Plain Ropivacaine

Active Comparator

Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Intervention: Ropivacaine 0.75% (Drug)

Ropivacaine + Buprenorphine

Experimental

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Intervention: Ropivacaine 0.75% + 300 mcg Buprenorphine (Drug)

Ropivacaine + Clonidine

Experimental

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Intervention: Ropivacaine 0.75% + 75 mcg clonidine (Drug)

Ropivaciane + Dexamethasone

Experimental

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Intervention: Ropivacaine 0.75% + 8 mg dexamethasone (Drug)

Outcomes

Primary Outcomes

Duration of Analgesia

Time Frame: 1-3 days post-operative

Patients are called 1-3 days post-operatively to assess when the analgesia of their nerve block wore off

Secondary Outcomes

  • Number of Patients Reporting Itching at Home(1-3 days)
  • Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area(Post-op Day 0 (baseline))
  • Sensory Duration of Block(Day 1-3)
  • Number of Patients Reporting Nausea in the PACU(Post-op day 0 (Baseline))
  • Motor Duration of Block(Day 1-3)
  • Block Set up Time(Day one)
  • Patient Reporting Vomiting at Home(1-3 days)
  • Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit)(Post-op Day 0 (Baseline))
  • Number of Patients Reporting Nausea at Home(1-3 days)
  • Pain Score Reported by Patients at First Phone Call(Day 1-3)
  • Number of Patients With Blood Pressure (BP) Changes in the PACU(Post-op Day 0 (baseline))
  • Number of Patients Reporting Itching in the PACU(Post-op day 0 (baseline))

Investigators

Sponsor
Melinda Seering
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Melinda Seering

Clinical Assistant Profession, Prinicipal Investigator

University of Iowa

Study Sites (1)

Loading locations...

Similar Trials