NCT02554357

Brief Summary

Shoulder arthroscopic causes post operative pain that outlasts analgesia provided by single injection nerve blocks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

July 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

6 months

First QC Date

July 11, 2015

Last Update Submit

September 7, 2016

Conditions

Injury of Shoulder Region

Outcome Measures

Primary Outcomes (2)

  • Worst pain

    assessed by the Modified Brief Pain Inventory short form Question 1 in the first postoperative week - postoperative day (POD) 1 through POD7

  • Satisfaction with analgesia

    assessed by the Overall Benefit of Analgesia Score (OBAS) in the first postoperative week postoperative day (POD)1 through POD7

Secondary Outcomes (5)

  • Onset of sensory block

    onset will be measured up to 30 minutes

  • Duration of sensory block

    duration will be measured up to 72 hours

  • Onset of motor block

    onset will be measured up to 30 minutes

  • duration of motor block

    duration will be measured up to 72 hours

  • functionality of the surgical arm

    assessed on the scale 0-5 in the first postoperative week - postoperative day (POD) 2- POD7

Study Arms (2)

Exparel block in arthroscopic surgery

EXPERIMENTAL

Evaluation of Exparel block in arthroscopic shoulder surgery.

Drug: Exparel block in arthroscopic shoulder surgery

Bupivacaine block in shoulder surgery

EXPERIMENTAL

Evaluation of Bupivacaine block in shoulder surgery.

Drug: Bupivacaine block in shoulder surgery

Interventions

Exparel block in arthroscopic shoulder surgeryDRUG

The interscalene block will be performed with ultrasound guidance and nerve stimulation.

Also known as: ISBPB with bupivacaine and Exparel
Exparel block in arthroscopic surgery
Bupivacaine block in shoulder surgeryDRUG

The interscalene block will be performed with ultrasound guidance and nerve stimulation.

Also known as: ISBPB with bupivacaine alone
Bupivacaine block in shoulder surgery

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dutch or English speaking adults
  • years or older ASA I-III physical class
  • Scheduled for elective arthroscopic shoulder surgery

You may not qualify if:

  • History of allergy to a local anesthetic
  • Baseline neurological deficit
  • Medical condition that would make it difficult to assess sensory distribution or communicate with the investigators' staff
  • Recent history (\< 3 months) of drug or alcohol abuse
  • Concomitant opioid therapy
  • Preexisting coagulation disorder
  • Infection at the injection site
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Anesthesiology Ziekenhuis Oost-Limburg

Genk, Belgium

Location

Department of Anesthesiology ZOL

Genk, Belgium

Location

Related Publications (1)

  • Vandepitte C, Kuroda M, Witvrouw R, Anne L, Bellemans J, Corten K, Vanelderen P, Mesotten D, Leunen I, Heylen M, Van Boxstael S, Golebiewski M, Van de Velde M, Knezevic NN, Hadzic A. Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shoulder Surgery. Reg Anesth Pain Med. 2017 May/Jun;42(3):334-341. doi: 10.1097/AAP.0000000000000560.

    PMID: 28157791DERIVED

MeSH Terms

Conditions

Shoulder Injuries

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Admir Hadzic, MD

    Director

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2015

First Posted

September 18, 2015

Study Start

July 1, 2015

Primary Completion

January 1, 2016

Study Completion

March 1, 2016

Last Updated

September 8, 2016

Record last verified: 2016-09

Locations

BE(2)