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

July 2, 2018 updated by: Melinda Seering

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital and Clinics, Ambulatory Surgery Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Plain Ropivacaine
Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Drug: Ropivacaine 0.75%
Only ropivacaine 0.75% is administered for this arm of the interscalene block
Other Names:
  • Naropin
Experimental: Ropivacaine + Buprenorphine
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Drug: Ropivacaine 0.75% + 300 mcg Buprenorphine
Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
Other Names:
  • Naropin + Buprenex
Experimental: Ropivacaine + Clonidine
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Drug: Ropivacaine 0.75% + 75 mcg clonidine
Ropivacaine 0.75% + 75 mcg Clonidine is administered for this arm of the interscalene block
Other Names:
  • Naropin + Duraclon
Experimental: Ropivaciane + Dexamethasone
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Drug: Ropivacaine 0.75% + 8 mg dexamethasone
Ropivacaine 0.75% + 8 mg Dexamethasone is administered for this arm of the interscalene block
Other Names:
  • Naropin + Decadron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1-3 days post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Block Set up Time
Time Frame: Day one
Patients are assessed from needle removal to when they are no longer able to feel cold on the blocked extremity
Day one
Sensory Duration of Block
Time Frame: Day 1-3
Patients are called 1-3 days post-operatively to assess when the sensory component of their nerve block wore off
Day 1-3
Patient Reporting Vomiting at Home
Time Frame: 1-3 days
Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.
1-3 days
Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit)
Time Frame: Post-op Day 0 (Baseline)
Vomiting in PACU (Post-Anesthesia Care Unit) for patients was looked at
Post-op Day 0 (Baseline)
Number of Patients Reporting Nausea at Home
Time Frame: 1-3 days
Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.
1-3 days
Number of Patients Reporting Nausea in the PACU
Time Frame: Post-op day 0 (Baseline)
PACU (Post-Anesthesia Care Unit) assessment of nausea
Post-op day 0 (Baseline)
Motor Duration of Block
Time Frame: Day 1-3
Patients are called 1-3 days post-operatively to assess when motor component of their nerve block wore off
Day 1-3
Number of Patients With Blood Pressure (BP) Changes in the PACU
Time Frame: Post-op Day 0 (baseline)
Blood pressure changes in PACU (Post-Anesthesia Care Unit) for patients was looked at
Post-op Day 0 (baseline)
Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area
Time Frame: Post-op Day 0 (baseline)
Blood pressure changes in Second Stage Recovery Area for patients was looked at
Post-op Day 0 (baseline)
Pain Score Reported by Patients at First Phone Call
Time Frame: Day 1-3
Patients are called 1-3 days post-operatively to assess pain. Pain score is 0-10 scale with 0 is no pain and 10 is most severe pain.
Day 1-3
Number of Patients Reporting Itching in the PACU
Time Frame: Post-op day 0 (baseline)
Patients itching was assessed post-op in the PACU.
Post-op day 0 (baseline)
Number of Patients Reporting Itching at Home
Time Frame: 1-3 days
Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.
1-3 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Position
Time Frame: Post-op Day 0 (Baseline)
Surgical position was recorded
Post-op Day 0 (Baseline)
Surgical Length
Time Frame: Post op Day 0 (Baseline)
Surgical length was recorded
Post op Day 0 (Baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Melinda Seering

Investigators

  • Principal Investigator: Melinda Seering, M.D., University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

April 11, 2017

First Submitted That Met QC Criteria

April 11, 2017

First Posted (Actual)

April 17, 2017

Study Record Updates

Last Update Posted (Actual)

July 3, 2018

Last Update Submitted That Met QC Criteria

July 2, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201304727

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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