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

Perineural Versus Systemic Dexamethasone as an Analgesic Adjunct to Ultrasound-Guided Ropivacaine Interscalene Blockade in Arthroscopic Rotator Cuff Repair

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Injury
• Intervention / Treatment: Drug: Ropivacaine; Drug: Dexamethasone; Drug: Dexamethasone; Drug: Normal saline; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85259
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: Naropin; Drug: Dexamethasone; 8 mg dexamethasone (perineural); Drug: Dexamethasone; 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml (intravenous); Drug: Normal saline; 5 ml normal saline (intravenous); Drug: Normal saline; 0.8 ml normal saline (perineural)
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 Names: Naropin; Drug: Dexamethasone; 8 mg dexamethasone (perineural); Drug: Dexamethasone; 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml (intravenous); Drug: Normal saline; 5 ml normal saline (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 Names: Naropin; Drug: Normal saline; 5 ml normal saline (intravenous); Drug: Normal saline; 0.8 ml normal saline (perineural)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Operative Opioid Dose at 24 Hours		approximately 24 hours after surgery
Time Until First Dose of Analgesic		Approximately 10 hours after surgery
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.	24 hours, 48 hours, 1 week

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: David Rosenfeld, MD, Mayo Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: October 7, 2011
• First Submitted That Met QC Criteria: October 7, 2011
• First Posted (Estimate): October 10, 2011

Study Record Updates

• Last Update Posted (Estimate): June 17, 2016
• Last Update Submitted That Met QC Criteria: May 16, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Dexamethasone; Ropivacaine; Pain blockade
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Anesthetics, Local; Dexamethasone; Dexamethasone acetate; BB 1101; Ropivacaine
• Other Study ID Numbers: 11-001266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO