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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Rosenfeld, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01450007
First received: October 7, 2011
Last updated: May 16, 2016
Last verified: May 2016
  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
Shoulder Injury
Drug: Ropivacaine
Drug: Dexamethasone
Drug: Normal saline
Phase 4

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:


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.


Secondary Outcome Measures:
  • Post Operative Opioid Dose at 24 Hours [ Time Frame: approximately 24 hours after surgery ] [ Designated as safety issue: No ]
  • Time Until First Dose of Analgesic [ Time Frame: Approximately 10 hours after surgery ] [ Designated as safety issue: No ]
  • Patient Satisfaction With Pain Control [ Time Frame: 24 hours, 48 hours, 1 week ] [ Designated as safety issue: No ]
    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.


Enrollment: 130
Study Start Date: May 2012
Study Completion Date: July 2015
Primary Completion Date: May 2015 (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%
Other Name: Naropin
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%
Other Name: Naropin
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%
Other Name: Naropin
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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450007

Locations
United States, Arizona
Mayo Clinic in Arizona
Phoenix, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: David Rosenfeld, MD Mayo Clinic
  More Information

Publications:
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
Results First Received: April 11, 2016
Last Updated: May 16, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Mayo Clinic:
Pain blockade
Ropivacaine
Dexamethasone

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Ropivacaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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 July 28, 2016