Clinical trial NCT03453866: Effect of Warmed Irrigation in Hip Arthroscopy Undergoing Hip Arthroscopy
Official title: Effect of Warmed Irrigation Fluid on Immediate Post-operative Pain Scores in Patients Undergoing Hip Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoro Acetabular Impingement
Pain, Postoperative
Keywords: Hip Arthroscopy
Warmed Fluids
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Visual Analog Score
timeFrame: Pre-operatively, 30 and 60 minutes after completion of surgery, Post Op Days 1 and 14.
Secondary outcomes:
measure: Changes in Temperature
timeFrame: 30-60 minutes after after completion of surgery
measure: Morphine Equivalent Dosage (MED)
timeFrame: After completion of surgery and at the 2-week Post Operative Visit
Other outcomes:
measure: Hip Outcomes Score (HOS)
timeFrame: Pre-operatively
measure: Veterans Rand 12 (VR-12)
timeFrame: Pre-Operatively
Locations:
city: Englewood
country: United States
facility: Steadman Hawkins Clinic, University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: James Genuario, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.