Effect of Warmed Irrigation in Hip Arthroscopy Undergoing Hip Arthroscopy
Primary Purpose
Femoro Acetabular Impingement, Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Warmed Arthroscopic Fluids
Room Temperature Arthroscopic Fluids
Sponsored by
About this trial
This is an interventional treatment trial for Femoro Acetabular Impingement focused on measuring Hip Arthroscopy, Warmed Fluids
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.
Sites / Locations
- Steadman Hawkins Clinic, University of Colorado Denver
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Warmed Arthroscopic Fluids
Room Temperature Arthroscopic Fluids
Arm Description
Arthroscopic Fluids will be warmed to 38 degrees Celsius during procedure with active warming device. Temperature will be measured in real time.
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.
Outcomes
Primary Outcome Measures
Changes in Visual Analog Score
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.
Secondary Outcome Measures
Changes in Temperature
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.
Morphine Equivalent Dosage (MED)
Morphine equivalent dose (MED) will be calculated in PACU and at the subject's routine two-week post-operative appointment via medication reconciliation.
Full Information
NCT ID
NCT03453866
First Posted
February 14, 2018
Last Updated
October 25, 2021
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT03453866
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 9, 2018 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
September 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoro Acetabular Impingement, Pain, Postoperative
Keywords
Hip Arthroscopy, Warmed Fluids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective Randomized Controlled Trial
Masking
ParticipantOutcomes Assessor
Masking Description
Sealed Opaque Envelope
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Warmed Arthroscopic Fluids
Arm Type
Experimental
Arm Description
Arthroscopic Fluids will be warmed to 38 degrees Celsius during procedure with active warming device. Temperature will be measured in real time.
Arm Title
Room Temperature Arthroscopic Fluids
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Warmed Arthroscopic Fluids
Intervention Description
Warmed Arthroscopic Fluids
Intervention Type
Procedure
Intervention Name(s)
Room Temperature Arthroscopic Fluids
Intervention Description
Room Temperature Arthroscopic Fluids
Primary Outcome Measure Information:
Title
Changes in Visual Analog Score
Description
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.
Time Frame
Pre-operatively, 30 and 60 minutes after completion of surgery, Post Op Days 1 and 14.
Secondary Outcome Measure Information:
Title
Changes in Temperature
Description
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.
Time Frame
30-60 minutes after after completion of surgery
Title
Morphine Equivalent Dosage (MED)
Description
Morphine equivalent dose (MED) will be calculated in PACU and at the subject's routine two-week post-operative appointment via medication reconciliation.
Time Frame
After completion of surgery and at the 2-week Post Operative Visit
Other Pre-specified Outcome Measures:
Title
Hip Outcomes Score (HOS)
Description
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.
Time Frame
Pre-operatively
Title
Veterans Rand 12 (VR-12)
Description
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.
Time Frame
Pre-Operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Genuario, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steadman Hawkins Clinic, University of Colorado Denver
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28948037
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.
Results Reference
background
PubMed Identifier
22117260
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.
Results Reference
background
PubMed Identifier
29217304
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.
Results Reference
background
PubMed Identifier
29131754
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.
Results Reference
background
PubMed Identifier
22546733
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.
Results Reference
background
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Effect of Warmed Irrigation in Hip Arthroscopy Undergoing Hip Arthroscopy
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