NCT02896959

Brief Summary

Postoperative surgical pain has been extensively study with regard to anaesthesia pain modalities, however little is published with regards to various arthroscopic shoulder surgical techniques. An intriguing characteristic of shoulder arthroscopy is the various arthroscopic pump pressures used by different surgeons. One could hypothesize that excessive water retention from the arthroscopic pump could causes excessive tissue pressure and swelling resulting in post operative pain. Unfortunately we could not find any literature in the English language regarding varying pressure pump settings on post operative pain control. For that reason we would like to assess how variable pump pressure effect tissue pressure over pre set time points, and how this may relate to post operative pain control.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Last Updated

September 12, 2016

Status Verified

September 1, 2016

Enrollment Period

2.7 years

First QC Date

September 7, 2016

Last Update Submit

September 7, 2016

Conditions

Shoulder Arthroscopy

Outcome Measures

Primary Outcomes (1)

  • Pain - VAS scale

    Two years

Study Arms (3)

25mmHg pressure

EXPERIMENTAL

Pump pressure of 25mmHg during rotator cuff repair

Procedure: Arthroscopic rotator cuff repair

45mmHg pressure

EXPERIMENTAL

Pump pressure of 45mmHg during rotator cuff repair

Procedure: Arthroscopic rotator cuff repair

65mmHg pressure

EXPERIMENTAL

Pump pressure of 65mmHg during rotator cuff repair

Procedure: Arthroscopic rotator cuff repair

Interventions

Arthroscopic rotator cuff repairPROCEDURE
25mmHg pressure45mmHg pressure65mmHg pressure

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients attending St. Joseph's hospital
  • Shoulder pathology amenable to arthroscopic surgery
  • Medically suitable for surgical management
  • Able to consent for surgery.

You may not qualify if:

  • Unable to consent
  • Active infection
  • Active malignancy
  • Drug or alcohol misuse
  • Work related injury
  • Lack of permanent home residence
  • Previous surgery to affected shoulder
  • Medical contraindiction to surgery
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 12, 2016

Study Start

October 1, 2016

Primary Completion

June 1, 2019

Last Updated

September 12, 2016

Record last verified: 2016-09