How Much is Too Much: Assessing Varying Pressure Pump Pressures in Post Operative Pain Control in Shoulder Arthroscopy.

NCT ID: NCT02896959

Last Updated: 2016-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Shoulder Arthroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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25mmHg pressure

Pump pressure of 25mmHg during rotator cuff repair

Group Type EXPERIMENTAL

Arthroscopic rotator cuff repair

Intervention Type PROCEDURE

45mmHg pressure

Pump pressure of 45mmHg during rotator cuff repair

Group Type EXPERIMENTAL

Arthroscopic rotator cuff repair

Intervention Type PROCEDURE

65mmHg pressure

Pump pressure of 65mmHg during rotator cuff repair

Group Type EXPERIMENTAL

Arthroscopic rotator cuff repair

Intervention Type PROCEDURE

Interventions

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Arthroscopic rotator cuff repair

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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106756

Identifier Type: -

Identifier Source: org_study_id

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