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

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Shoulder Injury

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01450007

11-001266

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 3 patient groups, including a placebo group

Dexamethasone block

Experimental group

Description:

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

Treatment:

Drug: Normal saline

Drug: Dexamethasone

Drug: Dexamethasone

Drug: Ropivacaine

Drug: Normal saline

Dexamethasone IV

Active Comparator group

Description:

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

Treatment:

Drug: Normal saline

Drug: Dexamethasone

Drug: Dexamethasone

Drug: Ropivacaine

Drug: Normal saline

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal saline

Drug: Ropivacaine

Drug: Normal saline