NCT00519584

Brief Summary

This study will test the hypothesis that ropivacaine in combination with either systemic or local steroid provides comparably longer-lasting analgesia tha ropivacaine alone.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jul 2007

Typical duration for not_applicable pain

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
8.4 years until next milestone

Results Posted

Study results publicly available

July 21, 2017

Completed
Last Updated

July 21, 2017

Status Verified

June 1, 2017

Enrollment Period

1.7 years

First QC Date

August 21, 2007

Results QC Date

April 18, 2017

Last Update Submit

June 21, 2017

Conditions

Pain

Keywords

Interscalene nerve blockDexamethasoneRopivacaine

Outcome Measures

Primary Outcomes (1)

  • the Duration of Analgesia

    the interval between the onset of sensory block and the initial PACU use of opioid analgesia for surgical site pain

    surgical date to postoperative day 1 (pod 0 -1 day)

Secondary Outcomes (3)

  • Time to a Significant Increase in Shoulder Discomfort

    during postoperative day 1 to 3

  • Maximum VRS Pain Scores at Rest

    postoperative day 1 day 2, day 3.

  • Total Opioid Consumption

    during first 3 days after surgery

Study Arms (4)

Ropivacaine/saline

PLACEBO COMPARATOR

Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block

Drug: RopivacaineDrug: Saline

Ropivacaine/dex

ACTIVE COMPARATOR

Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;

Drug: RopivacaineDrug: dex

bupivacaine/dex

ACTIVE COMPARATOR

bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.

Drug: dexDrug: Bupivacaine

bupivacaine/Saline

PLACEBO COMPARATOR

bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block

Drug: BupivacaineDrug: Saline

Interventions

RopivacaineDRUG

30 ml 0.5%

Ropivacaine/dexRopivacaine/saline
dexDRUG

8 mg (2 ml)

Also known as: Ropivacaine/dex
Ropivacaine/dexbupivacaine/dex
BupivacaineDRUG

30 ml 0.5%

bupivacaine/Salinebupivacaine/dex
SalineDRUG

0.9% saline; systemic and local

Also known as: placebo
Ropivacaine/salinebupivacaine/Saline

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing open shoulder procedures such as rotator cuff repair, capsular shift, subacromial decompression
  • Age between 18 and 70 years

You may not qualify if:

  • Contradictions for interscalene block
  • Coagulopathy
  • Infection at the needle insertion site
  • Moderate to severe chronic obstructive pulmonary disease (COPD)
  • Contralateral pneumothorax of diaphragmatic paralysis
  • Pregnancy
  • Preexisting neuropathy involving the surgical limb
  • Systemic glucocorticoid treatment within the last six months of surgery
  • Routine opioid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cleveland Clinic Hillcrest

Cleveland, Ohio, 44112, United States

Location

Cleveland Clinic /Euclid Hospital

Euclid, Ohio, 44119, United States

Location

MeSH Terms

Conditions

Pain

Interventions

RopivacaineBupivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
K. C. Cummings III, MD
Organization
Cleveland Clinic
cummink2@ccf.org
216-444-1016

Study Officials

  • Kenneth Cummings III, M.D.

    Cleveland Clinic/Hillcrest

    PRINCIPAL INVESTIGATOR

  • Daniel I Sessler, MD

    The Cleveland Clinic

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2007

First Posted

August 22, 2007

Study Start

July 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

July 21, 2017

Results First Posted

July 21, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)