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Completed

NCT Number: NCT01450007

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

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.

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Key information

Conditions

Shoulder Injury Shoulder Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Arizona

Phoenix, Arizona, 85259, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Ropivacaine

Drug

25 ml ropivacaine 0.5%

Other names: Naropin

Dexamethasone

Drug

8 mg dexamethasone (perineural)

normal saline

Drug

5 ml normal saline (intravenous)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 10, 2011
Registry last updated
Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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