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Ropivacaine Block Alone or With Perineural or Systemic Dexamethasone for Pain in Shoulder Surgery

Primary Purpose

Shoulder Injury

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Dexamethasone
Dexamethasone
Normal saline
Normal saline
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Shoulder Injury focused on measuring Pain blockade, Ropivacaine, Dexamethasone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Patients undergoing elective shoulder surgery by one of two surgeons highly experienced in the procedure.
  2. Patients are either: Opioid naïve; or Have not taken opiates for one month prior to surgery (tramadol is permissible).
  3. Patients have an American Society of Anesthesiology physical status I-III.

Exclusion criteria:

  1. Females who are pregnant.
  2. Patients who are taking chronic daily opiates for one month prior to surgery except tramadol.
  3. Diabetic patients.
  4. Patients with creatinine above 1.1mg/dL for females and above 1.3mg/dL for males.
  5. Patients with contralateral pneumothorax or diaphragmatic paralysis.
  6. Patients with coagulopathy.
  7. Patients with clinically significant previous nerve injury in surgical extremity.
  8. Patients with an allergy to NSAIDs.
  9. Patients who are refusing a block.
  10. Patients with a contraindication to ropivacaine, dexamethasone, or interscalene block due to other medical condition such as severe chronic obstructive pulmonary disease (COPD).

Sites / Locations

  • Mayo Clinic in Arizona

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone block

Dexamethasone IV

Placebo

Arm Description

Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline

Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml

Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline

Outcomes

Primary Outcome Measures

Duration of Sensory Blockade
Duration from time of block until complete resolution of sensory blockade in the shoulder is recorded in minutes by patient report.

Secondary Outcome Measures

Post Operative Opioid Dose at 24 Hours
Time Until First Dose of Analgesic
Patient Satisfaction With Pain Control
Pain was rated on a visual analogue scale with 0 = no pain, 3=mild pain, 5=moderate pain, 7=moderate to severe pain, and 10=severe pain.

Full Information

First Posted
October 7, 2011
Last Updated
May 16, 2016
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01450007
Brief Title
Ropivacaine Block Alone or With Perineural or Systemic Dexamethasone for Pain in Shoulder Surgery
Official Title
Perineural Versus Systemic Dexamethasone as an Analgesic Adjunct to Ultrasound-Guided Ropivacaine Interscalene Blockade in Arthroscopic Rotator Cuff Repair
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Pre-operative perineural injection of dexamethasone mixed with local anesthetic in peripheral nerve blockade for orthopedic surgery has been shown to prolong the length of analgesia, improve visual analog pain scores, decrease post-operative opioid use, and decrease post-operative nausea. No study has been published to determine if this effect is a result of systemic absorption of dexamethasone or is a local effect of the drug on neuronal activity at the injection site. This study is a prospective, randomized, double-blind, controlled study to compare pain block with (1) ropivacaine and saline plus intravenous saline vs (2) ropivacaine and dexamethasone plus intravenous saline vs (3) ropivacaine and saline plus intravenous dexamethasone. Patients will be recruited sequentially and assigned to the three groups at random in equal ratios. The hypothesis is that dexamethasone injected perineurally in combination with ropivacaine for interscalene brachial plexus block will yield longer duration of sensory blockade as compared to ropivacaine alone without intravenous or perineural dexamethasone and as compared to ropivacaine and intravenous dexamethasone. This result will suggest that the effect of dexamethasone is a result of direct neuronal activity at the injection site versus systemic absorption.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Injury
Keywords
Pain blockade, Ropivacaine, Dexamethasone

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone block
Arm Type
Experimental
Arm Description
Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
Arm Title
Dexamethasone IV
Arm Type
Active Comparator
Arm Description
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
25 ml ropivacaine 0.5%
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
8 mg dexamethasone (perineural)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml (intravenous)
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
5 ml normal saline (intravenous)
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
0.8 ml normal saline (perineural)
Primary Outcome Measure Information:
Title
Duration of Sensory Blockade
Description
Duration from time of block until complete resolution of sensory blockade in the shoulder is recorded in minutes by patient report.
Time Frame
Within 48 hours
Secondary Outcome Measure Information:
Title
Post Operative Opioid Dose at 24 Hours
Time Frame
approximately 24 hours after surgery
Title
Time Until First Dose of Analgesic
Time Frame
Approximately 10 hours after surgery
Title
Patient Satisfaction With Pain Control
Description
Pain was rated on a visual analogue scale with 0 = no pain, 3=mild pain, 5=moderate pain, 7=moderate to severe pain, and 10=severe pain.
Time Frame
24 hours, 48 hours, 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients undergoing elective shoulder surgery by one of two surgeons highly experienced in the procedure. Patients are either: Opioid naïve; or Have not taken opiates for one month prior to surgery (tramadol is permissible). Patients have an American Society of Anesthesiology physical status I-III. Exclusion criteria: Females who are pregnant. Patients who are taking chronic daily opiates for one month prior to surgery except tramadol. Diabetic patients. Patients with creatinine above 1.1mg/dL for females and above 1.3mg/dL for males. Patients with contralateral pneumothorax or diaphragmatic paralysis. Patients with coagulopathy. Patients with clinically significant previous nerve injury in surgical extremity. Patients with an allergy to NSAIDs. Patients who are refusing a block. Patients with a contraindication to ropivacaine, dexamethasone, or interscalene block due to other medical condition such as severe chronic obstructive pulmonary disease (COPD).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Rosenfeld, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26899862
Citation
Rosenfeld DM, Ivancic MG, Hattrup SJ, Renfree KJ, Watkins AR, Hentz JG, Gorlin AW, Spiro JA, Trentman TL. Perineural versus intravenous dexamethasone as adjuncts to local anaesthetic brachial plexus block for shoulder surgery. Anaesthesia. 2016 Apr;71(4):380-8. doi: 10.1111/anae.13409. Epub 2016 Feb 22.
Results Reference
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Ropivacaine Block Alone or With Perineural or Systemic Dexamethasone for Pain in Shoulder Surgery

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