Effect of Warmed Irrigation in Hip Arthroscopy Undergoing Hip Arthroscopy

October 25, 2021 updated by: University of Colorado, Denver

Effect of Warmed Irrigation Fluid on Immediate Post-operative Pain Scores in Patients Undergoing Hip Arthroscopy

The purpose of this study is to determine if pre-warming of arthroscopic fluid reduces immediate post-surgical pain in hip arthroscopy patients. The investigators hypothesize there will be a significant decrease in the Visual Analog Score (VAS) measured 30 minutes post-operatively in the warmed fluid group compared to the control group. Secondary outcome measures to be collected will include VAS scores 60 minutes after surgery and on post-operative day (POD) one. Additionally, the investigators will collect post-operative temperature measured 30 and 60 minutes post-operatively as well as morphine equivalent dosing in PACU and at the two-week follow up visit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the last two decades, hip arthroscopy for the treatment of femoral acetabular impingement has increased rapidly. Currently, over 30k hip scopes are performed annually in the United States (incidence 1.06 per 10K). Due to anatomical differences, hip arthroscopy procedures have the potential for significant fluid extravasation when compared to knee arthroscopy. A 2011 study on hip arthroscopy showed on average 9.68 liters of fluid were used for a standard hip procedure; of that 1.13 liters absorbed into the surrounding soft tissues. A recent systematic review and meta-analysis showed warming of arthroscopic fluids significantly decreased the risk of hypothermia during hip arthroscopy. Additionally, active warming has been shown to decrease the rate of surgical site infection during numerous procedures. In total knee arthroplasty patients, a forced air warming gown significantly reduced narcotic pain consumption compared to standard care. However, the benefits of active warming for decreasing post-operative pain has not been studied in hip arthroscopy patients. Specifically, the investigators were interested in the roll the pre-warming arthroscopic fluid plays in post-operative pain after hip arthroscopy. The purpose of this study is to see if pre-warming of arthroscopic fluid reduces immediate post-surgical pain and narcotic consumption in hip arthroscopy patients.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Englewood, Colorado, United States, 80112
        • Steadman Hawkins Clinic, University of Colorado Denver

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients aged 18-65 years with a confirmed diagnosis of Femoroacetabular impingement (FAI)
  • Required hip arthroscopy will be considered for the study
  • Pre-operative history and physical exam
  • Magnetic resonance imaging (MRI) before being indicated for arthroscopic surgery

Exclusion Criteria:

  • Taking narcotic medications at baseline
  • Have a history of complex regional pain syndrome,
  • Have hip arthritis,
  • Have undergone previous hip arthroscopic surgery, or
  • Are deemed incapable by the Principal Investigator of completing the study.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Warmed Arthroscopic Fluids
Arthroscopic Fluids will be warmed to 38 degrees Celsius during procedure with active warming device. Temperature will be measured in real time.
Procedure: Warmed Arthroscopic Fluids
Warmed Arthroscopic Fluids
Active Comparator: Room Temperature Arthroscopic Fluids
Arthroscopic fluids will be kept at room temperature and will not be warmed per current standard of care. Temperature will be measured in real time.
Procedure: Room Temperature Arthroscopic Fluids
Room Temperature Arthroscopic Fluids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Visual Analog Score
Time Frame: Pre-operatively, 30 and 60 minutes after completion of surgery, Post Op Days 1 and 14.
A Visual Analog Score (VAS) will be measured pre-operatively, 30 and 60 minutes after patient arrival in the post-anesthesia care unit (PACU). Additionally, VAS will be collected in the clinic on post-operative day (POD) 1 and POD 14. The visual analog scale measures subject reported pain on a scale of 0-100 with a score of 0 indicating no pain and 100 indicating the worst pain possible.
Pre-operatively, 30 and 60 minutes after completion of surgery, Post Op Days 1 and 14.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Temperature
Time Frame: 30-60 minutes after after completion of surgery
Subject core temperature will be collected 30 and 60 minutes after arrival in PACU. The method for collection will be done via current standard of care.
30-60 minutes after after completion of surgery
Morphine Equivalent Dosage (MED)
Time Frame: After completion of surgery and at the 2-week Post Operative Visit
Morphine equivalent dose (MED) will be calculated in PACU and at the subject's routine two-week post-operative appointment via medication reconciliation.
After completion of surgery and at the 2-week Post Operative Visit

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hip Outcomes Score (HOS)
Time Frame: Pre-operatively
The HOS has been validated in patients with femoral acetabular impingement and has two subscales (Activities of Daily Living and Sports). The ADL subscale contained 19 items pertaining to basic daily activities, and the sports subscale contained 9 items pertaining to higher-level activities. The ADL and sports subscales are scored separately. The response to each item on the ADL subscale is scored from 4 to 0, with 4 indicating "no difficulty" and 0 indicating "unable to do." The scores for each of the items are added together to obtain a total. The total number of items with a response is multiplied by 4 to obtain the highest potential score. The item score total is divided by the highest potential score. This value is then multiplied by 100 to obtain a percentage. The sports subscale is scored in a similar manner, with the highest potential score being 36. A higher score represents a higher level of physical function.
Pre-operatively
Veterans Rand 12 (VR-12)
Time Frame: Pre-Operatively
The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life and to estimate disease. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a Physical Component Score (PCS) and a Mental Component Score (MCS). PCS and MCS summary scores are standardized using a t-score transformation and normed to a U.S. population of a score of 50 and a standard deviation of 10. The subscales are not combined or averaged for a total score. A Higher score represents a higher function.
Pre-Operatively

Collaborators and Investigators

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

Sponsor

University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 9, 2018

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

September 20, 2021

Study Registration Dates

First Submitted

February 14, 2018

First Submitted That Met QC Criteria

February 26, 2018

First Posted (Actual)

March 5, 2018

Study Record Updates

Last Update Posted (Actual)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 25, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-2399

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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