The Effect of Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine or Bupivacaine

This study will test the hypothesis that adding dexamethasone significantly prolongs the duration of ropivacaine and bupivacaine analgesia, and that the magnitude of the effect differs among the two local anaesthetics.. Participants will be patients undergoing shoulder surgery with an interscalene nerve block.

Study Overview

• Status: Terminated
• Conditions: Anesthesia, Local; Shoulder Surgery
• Intervention / Treatment: Drug: saline; Drug: ropivacaine; Drug: Bupivacaine; Drug: Dexamethasone

Detailed Description

This is a double-blinded randomized study of four groups of patients undergoing shoulder surgery using interscalene nerve blocks. Participants will be randomized into one of four groups:

• Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (placebo) for interscalene block;
• Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline (placebo);
• Ropivacaine and steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic;
• Bupivacaine and steroid: 30 ml 0.5% bupivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic.

The primary outcome is the duration of the interscalene nerve block which is time to first analgesic request after PACU discharge.

Kaplan-Meier survival density estimation and stratified Cox proportional hazard regression were used to compare groups.

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 75 years
• Patients undergoing shoulder procedures, such as rotator cuff repair, capsular shift, shoulder arthroplasty, subacromial decompression

Exclusion Criteria:

• Contraindications to interscalene block (Coagulopathy, infection at the needle insertion site, moderate to severe chronic obstructive pulmonary disease, contralateral pneumothorax or diaphragmatic paralysis)
• Pregnancy
• Pre-existing neuropathy involving the surgical limb
• Systemic glucocorticoid treatment (for 2 weeks or more) within six months of surgery
• Chronic opioid use (greater than 30 mg oral oxycodone equivalent per day)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 1; Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block	Drug: saline; 2 ml 0.9% saline (placebo); Drug: ropivacaine; 30 ml 0.5% ropivacaine
Placebo Comparator: Group 2; Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline	Drug: saline; 2 ml 0.9% saline (placebo); Drug: Bupivacaine; 30 ml 0.5% bupivacaine
Active Comparator: Group 3; Group 3 Ropivacaine and dexamethasone: 30 ml 0.5% ropivacaine mixed with dexamethasone 8 mg (2 ml)	Drug: ropivacaine; 30 ml 0.5% ropivacaine; Drug: Dexamethasone; dexamethasone 8 mg (2 ml)
Active Comparator: Group 4; Group 4 Bupivacaine and steroid: 30 ml 0.5% bupivacaine mixed with dexamethasone 8 mg (2 ml).	Drug: Bupivacaine; 30 ml 0.5% bupivacaine; Drug: Dexamethasone; dexamethasone 8 mg (2 ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Duration of the Interscalene Nerve Block Which is Time to First Administration of Pain Medication After Block	Postoperative day 1, 2 and 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Report of Pain		Postoperative day 1, 2 and 3
Median Maximum VAS Pain Scores at Rest	Visual Analogue Scale (VAS) pain scale is used to describe the severity or intensity of pain. It ranges from 0 to 10. Zero indicates"no pain at all" and ten indicates "worst pain imaginable." , The higher of the score, the worse of the pain.	Postoperative day 1, 2 and 3
Total Three-day Opioid Consumption in Oral Oxycodone Equivalent		Postoperative day 1, 2 and 3

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Kenneth Cummings, MD, The Cleveland Clinic; Study Director: Ivan Parra Sanchez, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: December 2, 2008
• First Submitted That Met QC Criteria: December 2, 2008
• First Posted (Estimate): December 3, 2008

Study Record Updates

• Last Update Posted (Actual): May 1, 2017
• Last Update Submitted That Met QC Criteria: March 21, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: ropivacaine; bupivacaine; glucocorticoid
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Bupivacaine; Ropivacaine
• Other Study ID Numbers: 08-647

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO