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

NCT00801138 | Terminated Results

• 1 other identifier: 08-647
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia, Local; Shoulder Surgery

Keywords

ropivacaine; bupivacaine; glucocorticoid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to First Report of Pain

  Postoperative day 1, 2 and 3

• Median Maximum VAS Pain Scores at Rest

  Postoperative day 1, 2 and 3

• Total Three-day Opioid Consumption in Oral Oxycodone Equivalent

  Postoperative day 1, 2 and 3

Study Arms (4)

Group 1

PLACEBO COMPARATOR

Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block

Drug: saline; Drug: ropivacaine

Group 2

PLACEBO COMPARATOR

Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline

Drug: saline; Drug: Bupivacaine

Group 3

ACTIVE COMPARATOR

Group 3 Ropivacaine and dexamethasone: 30 ml 0.5% ropivacaine mixed with dexamethasone 8 mg (2 ml)

Drug: Dexamethasone; Drug: ropivacaine

Group 4

ACTIVE COMPARATOR

Group 4 Bupivacaine and steroid: 30 ml 0.5% bupivacaine mixed with dexamethasone 8 mg (2 ml).

Drug: Dexamethasone; Drug: Bupivacaine

Interventions

saline DRUG

2 ml 0.9% saline (placebo)

Group 1; Group 2

Dexamethasone DRUG

dexamethasone 8 mg (2 ml)

Group 3; Group 4

ropivacaine DRUG

30 ml 0.5% ropivacaine

Group 1; Group 3

Bupivacaine DRUG

30 ml 0.5% bupivacaine

Group 2; Group 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Sodium Chloride; Dexamethasone; Ropivacaine; Bupivacaine

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Daniel I Sessler, MD
• Organization: Cleveland Clinic Foundation

sesslerd@ccf.org

2164458396

Study Officials

• Kenneth Cummings, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Daniel I Sessler, MD

  The Cleveland Clinic

  STUDY CHAIR

• Ivan Parra Sanchez, MD

  The Cleveland Clinic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2008
• First Posted: December 3, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 1, 2017
• Results First Posted: May 1, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)