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

NCT ID: NCT01450007

Last Updated: 2016-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Dexamethasone block

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

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

25 ml ropivacaine 0.5%

Dexamethasone

Intervention Type: DRUG

8 mg dexamethasone (perineural)

Normal saline

Intervention Type: DRUG

5 ml normal saline (intravenous)

Dexamethasone IV

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

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

25 ml ropivacaine 0.5%

Dexamethasone

Intervention Type: DRUG

8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml (intravenous)

Normal saline

Intervention Type: DRUG

0.8 ml normal saline (perineural)

Placebo

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

Group Type: PLACEBO_COMPARATOR

Ropivacaine

Intervention Type: DRUG

25 ml ropivacaine 0.5%

Normal saline

Intervention Type: DRUG

5 ml normal saline (intravenous)

Normal saline

Intervention Type: DRUG

0.8 ml normal saline (perineural)

Interventions

Ropivacaine

25 ml ropivacaine 0.5%

Intervention Type: DRUG

Dexamethasone

8 mg dexamethasone (perineural)

Intervention Type: DRUG

Dexamethasone

8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml (intravenous)

Intervention Type: DRUG

Normal saline

5 ml normal saline (intravenous)

Intervention Type: DRUG

Normal saline

0.8 ml normal saline (perineural)

Intervention Type: DRUG

Other Intervention Names

Naropin

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

David Rosenfeld

Assistant Professor of Anesthesiology, College of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Rosenfeld, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Arizona

Phoenix, Arizona, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 26899862 (View on PubMed)

Other Identifiers

11-001266

Identifier Type: -

Identifier Source: org_study_id