Recruiting

Interscalene Catheters

Sponsor:

OAD Orthopaedics

Code:

NCT01606332

Conditions

Frozen Shoulder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Interscalene block with nerve catheter

Study Details

Brief summary:

In patients who undergo shoulder manipulation for idiopathic adhesive capsulitis, a postoperative indwelling analgesic pain catheter will improve patient outcomes by decreasing shoulder pain and improving range of motion compared to a single-dose interscalene block.

Conditions

Frozen Shoulder

Study ID

NCT01606332

Start date

Jun, 2012

Status verified date

Jun, 2013

Completion date

Jul, 2014

Anticipated

Primary completion date

Jul, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Males and Females over the age of 18 with a diagnosis of idiopathic adhesive capsulitis
  • Failed conservative treatment for a minimum of 4 months
  • Patient had 3 sequential office visits with no clinical improvement

Exclusion Criteria:

  • Adhesive capsulitis following a surgical procedure and/or fracture

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Single in interscalene block

Single indwelling interscalene block with ropivacaine 0.5% 10ml

experimental: Interscalene block with nerve catheter

Interscalene block with ropivacaine 0.5% 10ml and placement of an indwelling nerve catheter with ropivacaine 0.2% @5ml/hr for 24 hours

Interventions

Interscalene block with nerve catheter

Interscalene block with ropivacaine 0.5% 10ml and placement of an indwelling nerve catheter with ropivacaine 0.2% @5ml/hr for 24 hours

Primary outcome measure

  • Improvement in shoulder function as demonstrated by increased range of motion [ Time Frame: 10 days, 4, 8, 16 weeks and 6 months ]

Central Contacts and Locations

Central contacts

Marjorie Delaney, APN

630-225-2554marjorie.delaney@oadortho.com

Locations

OAD Orthopaedics

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Marjorie L Delaney, APN

630-225-2554marjorie.delaney@oadortho.com

More Information

Sponsor

OAD Orthopaedics

Last update posted

Jun 11, 2013

Last verified

Jun, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by OAD Orthopaedics on 2013-06-11.