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Effect of Warmed Irrigation in Hip Arthroscopy Undergoing Hip Arthroscopy

NCT ID: NCT03453866

Last Updated: 2021-11-01

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

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-09

Study Completion Date

2021-09-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Femoro Acetabular Impingement Pain, Postoperative

Keywords

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Hip Arthroscopy Warmed Fluids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Sealed Opaque Envelope

Study Groups

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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.

Group Type EXPERIMENTAL

Warmed Arthroscopic Fluids

Intervention Type PROCEDURE

Warmed Arthroscopic Fluids

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.

Group Type ACTIVE_COMPARATOR

Room Temperature Arthroscopic Fluids

Intervention Type PROCEDURE

Room Temperature Arthroscopic Fluids

Interventions

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Warmed Arthroscopic Fluids

Warmed Arthroscopic Fluids

Intervention Type PROCEDURE

Room Temperature Arthroscopic Fluids

Room Temperature Arthroscopic Fluids

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Genuario, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Steadman Hawkins Clinic, University of Colorado Denver

Englewood, Colorado, United States

Site Status

Countries

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United States

References

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Truntzer JN, Shapiro LM, Hoppe DJ, Abrams GD, Safran MR. Hip arthroscopy in the United States: an update following coding changes in 2011. J Hip Preserv Surg. 2017 Mar 23;4(3):250-257. doi: 10.1093/jhps/hnx004. eCollection 2017 Aug.

Reference Type BACKGROUND
PMID: 28948037 (View on PubMed)

Stafford GH, Malviya A, Villar RN. Fluid extravasation during hip arthroscopy. Hip Int. 2011 Nov-Dec;21(6):740-3. doi: 10.5301/HIP.2011.8845.

Reference Type BACKGROUND
PMID: 22117260 (View on PubMed)

Steelman VM, Chae S, Duff J, Anderson MJ, Zaidi A. Warming of Irrigation Fluids for Prevention of Perioperative Hypothermia During Arthroscopy: A Systematic Review and Meta-analysis. Arthroscopy. 2018 Mar;34(3):930-942.e2. doi: 10.1016/j.arthro.2017.09.024. Epub 2017 Dec 6.

Reference Type BACKGROUND
PMID: 29217304 (View on PubMed)

Ousey K, Edward KL, Lui S, Stephenson J, Walker K, Duff J, Leaper D. Perioperative, local and systemic warming in surgical site infection: a systematic review and meta-analysis. J Wound Care. 2017 Nov 2;26(11):614-624. doi: 10.12968/jowc.2017.26.11.614.

Reference Type BACKGROUND
PMID: 29131754 (View on PubMed)

Benson EE, McMillan DE, Ong B. The effects of active warming on patient temperature and pain after total knee arthroplasty. Am J Nurs. 2012 May;112(5):26-33; quiz 34, 42. doi: 10.1097/01.NAJ.0000414315.41460.bf.

Reference Type BACKGROUND
PMID: 22546733 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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17-2399

Identifier Type: -

Identifier Source: org_study_id