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

September 7, 2016 updated by: Lawson Health Research Institute
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 25mmHg pressure
Pump pressure of 25mmHg during rotator cuff repair
Procedure: Arthroscopic rotator cuff repair
Experimental: 45mmHg pressure
Pump pressure of 45mmHg during rotator cuff repair
Procedure: Arthroscopic rotator cuff repair
Experimental: 65mmHg pressure
Pump pressure of 65mmHg during rotator cuff repair
Procedure: Arthroscopic rotator cuff repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain - VAS scale
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 12, 2016

Study Record Updates

Last Update Posted (Estimate)

September 12, 2016

Last Update Submitted That Met QC Criteria

September 7, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106756

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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