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

NCT01450007 | Completed Phase 4 Results

• 1 other identifier: 11-001266
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Injury

Keywords

Pain blockade; Ropivacaine; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  24 hours, 48 hours, 1 week

Study Arms (3)

Dexamethasone block

EXPERIMENTAL

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

Drug: Ropivacaine; Drug: Dexamethasone; Drug: Normal saline

Dexamethasone IV

ACTIVE COMPARATOR

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; Drug: Dexamethasone; Drug: Normal saline

Placebo

PLACEBO COMPARATOR

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

Drug: Ropivacaine; Drug: Normal saline

Interventions

Ropivacaine DRUG

25 ml ropivacaine 0.5%

Also known as: Naropin

Dexamethasone IV; Dexamethasone block; Placebo

Dexamethasone DRUG

8 mg dexamethasone (perineural)

Dexamethasone block

Normal saline DRUG

5 ml normal saline (intravenous)

Dexamethasone block; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Phoenix, Arizona, 85259, United States

Location

Related Publications (1)

• 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.

  PMID: 26899862 RESULT

MeSH Terms

Conditions

Shoulder Injuries

Interventions

Ropivacaine; Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Although it was designed to have 80% power at 120 patients, double this number would be required to detect very small differences (\<10%) in the systemic and perineural groups.

Results Point of Contact

• Title: Dr. David M. Rosenfeld
• Organization: Mayo Clinic

Rosenfeld.David@mayo.edu

480-301-7586

Study Officials

• David Rosenfeld, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology, College of Medicine

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 10, 2011
• Study Start: May 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2015
• Last Updated: June 17, 2016
• Results First Posted: May 17, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)