Clinical trial NCT03117140: Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block
Official title: A Prospective Triple-masked Randomized Controlled Trial Measuring Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia, Local
Keywords: Brachial Plexus Block
Clonidine
Dexamethasone
Buprenorphine
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients who have or are:

  1. Orthopedics service patients having shoulder surgery
  2. ASA(American Society of Anesthesiologists) class I, II, or III.
  3. Patients at least 18 years old but less than 71 years old.
  4. Patients giving informed consent.
  5. Non-Emergency Surgery

     Exclusion Criteria:
* Patients who have or are:

  1. An inability to cooperate during the block placement.
  2. Neuropathy of the planned extremity to block
  3. Diabetes
  4. Documented Kidney Disease
  5. Documented Liver Disease
  6. A lack of or inability to give informed consent.
  7. Currently incarcerated.
  8. Pregnant

Primary outcomes:
measure: Duration of Analgesia
timeFrame: 1-3 days post-operative
Secondary outcomes:
measure: Block Set up Time
timeFrame: Day one
measure: Sensory Duration of Block
timeFrame: Day 1-3
measure: Patient Reporting Vomiting at Home
timeFrame: 1-3 days
measure: Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit)
timeFrame: Post-op Day 0 (Baseline)
measure: Number of Patients Reporting Nausea at Home
timeFrame: 1-3 days
measure: Number of Patients Reporting Nausea in the PACU
timeFrame: Post-op day 0 (Baseline)
measure: Motor Duration of Block
timeFrame: Day 1-3
measure: Number of Patients With Blood Pressure (BP) Changes in the PACU
timeFrame: Post-op Day 0 (baseline)
measure: Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area
timeFrame: Post-op Day 0 (baseline)
measure: Pain Score Reported by Patients at First Phone Call
timeFrame: Day 1-3
measure: Number of Patients Reporting Itching in the PACU
timeFrame: Post-op day 0 (baseline)
measure: Number of Patients Reporting Itching at Home
timeFrame: 1-3 days
Other outcomes:
measure: Surgical Position
timeFrame: Post-op Day 0 (Baseline)
measure: Surgical Length
timeFrame: Post op Day 0 (Baseline)
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics, Ambulatory Surgery Clinic
state: Iowa
Study officials:
affiliation: University of Iowa
name: Melinda Seering, M.D.
role: PRINCIPAL_INVESTIGATOR
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