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

Study Overview
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Brief Summary
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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.

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

Conditions
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Shoulder Injury

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Dexamethasone
* Drug: Dexamethasone
* Drug: Normal saline
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone block<br>Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline | Drug: Ropivacaine<br>* 25 ml ropivacaine 0.5%<br>* Other names: Naropin;Drug: Dexamethasone<br>* 8 mg dexamethasone (perineural)<br>Drug: Normal saline<br>* 5 ml normal saline (intravenous)<br>|
| Active Comparator: Dexamethasone IV<br>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<br>* 25 ml ropivacaine 0.5%<br>* Other names: Naropin;Drug: Dexamethasone<br>* 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml (intravenous)<br>Drug: Normal saline<br>* 0.8 ml normal saline (perineural)<br>|
| Placebo Comparator: Placebo<br>Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline | Drug: Ropivacaine<br>* 25 ml ropivacaine 0.5%<br>* Other names: Naropin;Drug: Normal saline<br>* 5 ml normal saline (intravenous)<br>Drug: Normal saline<br>* 0.8 ml normal saline (perineural)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain blockade, Ropivacaine, Dexamethasone