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

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Interscalene Blockade in Elective Arthroscopic Rotator Cuff Repair

Intervention: Ropivacaine (Drug); Dexamethasone (Drug); Dexamethasone (Drug); Normal saline (Drug); Normal saline (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
David Rosenfeld, MD, Principal Investigator, Affiliation: Mayo Clinic

Overall contact:
Andre Watkins, Phone: 480-342-0349, Email: watkins.andre@mayo.edu

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome: Duration of sensory blockade

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria: 1. Patients are either males or non-pregnant females >/=18 years old undergoing elective arthroscopic rotator cuff repair 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 COPD.

Locations and Contacts

Andre Watkins, Phone: 480-342-0349, Email: watkins.andre@mayo.edu

Mayo Clinic in Arizona, Phoenix, Arizona 85259, United States; Recruiting
Andre Watkins, Phone: 480-342-0349, Email: watkins.andre@mayo.edu
Additional Information

Starting date: May 2012
Last updated: February 20, 2014

Page last updated: August 23, 2015

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