Effect of Warmed Irrigation in Hip Arthroscopy Undergoing Hip Arthroscopy
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|ClinicalTrials.gov Identifier: NCT03453866|
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : June 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Femoro Acetabular Impingement Pain, Postoperative||Procedure: Warmed Arthroscopic Fluids Procedure: Room Temperature Arthroscopic Fluids||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective Randomized Controlled Trial|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Sealed Opaque Envelope|
|Official Title:||Effect of Warmed Irrigation Fluid on Immediate Post-operative Pain Scores in Patients Undergoing Hip Arthroscopy|
|Actual Study Start Date :||February 9, 2018|
|Estimated Primary Completion Date :||February 9, 2020|
|Estimated Study Completion Date :||February 9, 2020|
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
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453866
|Contact: James Genuario, MDfirstname.lastname@example.org|
|Contact: Michael Rose, MDemail@example.com|
|United States, Colorado|
|Steadman Hawkins Clinic, University of Colorado Denver||Recruiting|
|Greenwood Village, Colorado, United States, 80111|
|Contact: James Genuario, MD 303-694-3333 firstname.lastname@example.org|
|Contact: Michael Rose, MD 303-694-3333 email@example.com|
|Principal Investigator:||James Genuario, MD||University of Colorado, Denver|