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

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ClinicalTrials.gov Identifier: NCT01450007
Recruitment Status : Completed
First Posted : October 10, 2011
Results First Posted : May 17, 2016
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
David Rosenfeld, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Shoulder Injury Drug: Ropivacaine Drug: Dexamethasone Drug: Normal saline Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : July 2015


Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Duration of Sensory Blockade [ Time Frame: Within 48 hours ]
    Duration from time of block until complete resolution of sensory blockade in the shoulder is recorded in minutes by patient report.


Secondary Outcome Measures :
  1. Post Operative Opioid Dose at 24 Hours [ Time Frame: approximately 24 hours after surgery ]
  2. Time Until First Dose of Analgesic [ Time Frame: Approximately 10 hours after surgery ]
  3. Patient Satisfaction With Pain Control [ Time Frame: 24 hours, 48 hours, 1 week ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
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
First Posted: October 10, 2011    Key Record Dates
Results First Posted: May 17, 2016
Last Update Posted: June 17, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by David Rosenfeld, Mayo Clinic:
Pain blockade
Ropivacaine
Dexamethasone

Additional relevant MeSH terms:
Shoulder Injuries
Wounds and Injuries
Dexamethasone acetate
Dexamethasone
Ropivacaine
BB 1101
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