NCT02267044

Brief Summary

Shoulder replacement surgery is recognized as having the potential to cause a considerable amount of postoperative pain. Adequate management of pain after surgery is necessary not only to improve the patient's wellbeing but also to facilitate recovery. Several regional anesthesia techniques are available to combat postoperative pain in the shoulder replacement surgery patient, however, which method provides superior pain relief remains unknown. The purpose of this study is to examine the effectiveness of a continuous interscalene block versus a single shot interscalene block for postoperative pain relief in the shoulder replacement patient. Patients undergoing shoulder replacement surgery will experience more effective pain relief with a continuous interscalene block versus and single shot interscalene block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

October 26, 2018

Status Verified

October 1, 2018

Enrollment Period

2.2 years

First QC Date

August 12, 2014

Last Update Submit

October 24, 2018

Conditions

Primary Osteoarthritis, Unspecified Shoulder

Outcome Measures

Primary Outcomes (1)

  • Pain Score Measure

    Patients will be assessed for pain levels by visual analog scale while in the hospital per nursing protocol. Electronic Medical Record will be used to acquire pain scores.

    participants will be followed for the duration of the hospital stay, an expected average of 3 days

Secondary Outcomes (2)

  • Morphine Sulfate Equivalence consumption

    participants morphine sulfate consumption will be gathered for the duration of the hospital stay, an expected average of 3 days

  • Pain control Satisfaction Score

    10 day post operative

Study Arms (2)

Ropivacaine Single Shot Block

ACTIVE COMPARATOR

Single Shot Interscalene block patients will receive a single shot of 30ml of 0.5% Ropivacaine prior to surgery

Drug: Ropivacaine

Ropivacaine Continuous block

ACTIVE COMPARATOR

Continuous Interscalene block patients will receive a shot of up to 30ml of 0.5% Ropivacaine and then a catheter is placed. The catheter is secured with Dermabond and Tegaderm. Once surgery is complete, the catheter is connected to a pain ball system which holds 400ml of 0.2% Ropivacaine local anesthetic. The rate is locked in at 8ml/hr. Catheter is pulled once the pain ball is empty.

Drug: Ropivacaine

Interventions

RopivacaineDRUG

The drug used for the interscalene blocks

Also known as: Naropin
Ropivacaine Continuous blockRopivacaine Single Shot Block

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Surgical candidate for primary total shoulder replacement, hemiarthroplasty, or reverse total shoulder replacement
  • patient must be 18 years or older and willing to sign and date an Institutional Review Board informed consent form, and
  • must be able to understand and agree to follow study protocol.

You may not qualify if:

  • severe bronchopulmonary disease,
  • oxygen dependent,
  • existing nerve injury,
  • BMI \> 40,
  • coagulation disorders,
  • allergy to ropivicaine,
  • history of drug or alcohol abuse,
  • American Academy of Anaesthesiologists physical status classification \> lll,
  • pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

  • Borgeat A, Tewes E, Biasca N, Gerber C. Patient-controlled interscalene analgesia with ropivacaine after major shoulder surgery: PCIA vs PCA. Br J Anaesth. 1998 Oct;81(4):603-5. doi: 10.1093/bja/81.4.603.

    PMID: 9924240BACKGROUND

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Samer Hasan, MD

    Cincinnati Sportsmedicine and Orthopaedic Center

    PRINCIPAL INVESTIGATOR

  • Robert Rolf, MD

    Beacon Orthopaedic Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2014

First Posted

October 17, 2014

Study Start

August 1, 2014

Primary Completion

October 1, 2016

Study Completion

April 1, 2017

Last Updated

October 26, 2018

Record last verified: 2018-10

Locations

US(1)