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

This study is currently recruiting participants.
Verified November 2012 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
David Rosenfeld, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01450007
First received: October 7, 2011
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Interscalene Blockade in Elective Arthroscopic Rotator Cuff Repair
 Drug: Ropivacaine
Drug: Dexamethasone
Drug: Normal saline
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Perineural Versus Systemic Dexamethasone as an Analgesic Adjunct to Ultrasound-Guided Ropivacaine Interscalene Blockade in Arthroscopic Rotator Cuff Repair

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Duration of sensory blockade [ Time Frame: Within 48 hours ] [ Designated as safety issue: No ]
    Duration from time of block until complete resolution of sensory blockade in the shoulder is recorded in minutes by patient report


Estimated Enrollment: 120
Study Start Date: May 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexamethasone block
Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
 Drug: Ropivacaine
25 ml ropivacaine 0.5%
Drug: Dexamethasone
8 mg dexamethasone (perineural)
Drug: Normal saline
5 ml normal saline (intravenous)
Active Comparator: Dexamethasone IV
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
 Drug: Ropivacaine
25 ml ropivacaine 0.5%
Drug: Dexamethasone
8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml (intravenous)
Drug: Normal saline
0.8 ml normal saline (perineural)
Placebo Comparator: Placebo
Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
 Drug: Ropivacaine
25 ml ropivacaine 0.5%
Drug: Normal saline
5 ml normal saline (intravenous)
Drug: Normal saline
0.8 ml normal saline (perineural)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Patients are either males or non-pregnant females >/=18 years old undergoing elective arthroscopic rotator cuff repair 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 COPD.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450007

Contacts
Contact: Andre Watkins 480-342-0349 watkins.andre@mayo.edu

Locations
United States, Arizona
Mayo Clinic in Arizona Recruiting
Phoenix, Arizona, United States, 85259
Contact: Andre Watkins     480-342-0349     watkins.andre@mayo.edu    
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: David Rosenfeld, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: David Rosenfeld, Assistant Professor of Anesthesiology, College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01450007     History of Changes
Other Study ID Numbers: 11-001266
Study First Received: October 7, 2011
Last Updated: November 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Pain blockade
Ropivacaine
Dexamethasone
Arthroscopic rotator cuff repair

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Ropivacaine
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
 Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents

ClinicalTrials.gov processed this record on May 16, 2013