Femoro Acetabular ImpingementNCT03453866
Effect of Warmed Irrigation in Hip Arthroscopy Undergoing Hip Arthroscopy
A study testing Warmed Arthroscopic Fluids and Room Temperature Arthroscopic Fluids in people with Femoro Acetabular Impingement and Pain, Postoperative, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Femoro Acetabular Impingement, Pain, Postoperative
- What is being tested?
- Warmed Arthroscopic Fluids and Room Temperature Arthroscopic Fluids
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2018to 20 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Steadman Hawkins Clinic, University of Colorado Denver
Englewood, Colorado, 80112
About this study
Official title: 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.
Read the 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.
- Conditions
- Femoro Acetabular Impingement, Pain, Postoperative
- Being tested
- Warmed Arthroscopic Fluids, Room Temperature Arthroscopic Fluids
- Keywords
- Hip Arthroscopy, Warmed Fluids
- Medical subject headings
- Femoracetabular Impingement, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warmed Arthroscopic FluidsProcedure or surgery
Warmed Arthroscopic Fluids
Room Temperature Arthroscopic FluidsProcedure or surgery
Room Temperature Arthroscopic Fluids
| Study group | Role | What they receive |
|---|---|---|
| Warmed Arthroscopic Fluids | Experimental | Arthroscopic Fluids will be warmed to 38 degrees Celsius during procedure with active warming device. Temperature will be measured in real time. Receives: Procedure: Warmed Arthroscopic Fluids |
| Room Temperature Arthroscopic Fluids | Active comparator | 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. Receives: Procedure: Room Temperature Arthroscopic Fluids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-operatively, 30 and 60 minutes after completion of surgery, Post Op Days 1 and 14.
Secondary outcomes (2)
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.
Measured: 30-60 minutes after after completion of surgery
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.
Measured: After completion of surgery and at the 2-week Post Operative Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start9 Feb 2018
- Primary completion1 Aug 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Femoro Acetabular ImpingementStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Genuario, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453866
- Sponsor's protocol ID
- 17-2399
- Status last verified
- Oct 2021
- First submitted
- 14 Feb 2018
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28948037Stafford 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.
PubMed 22117260Steelman 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.
PubMed 29217304Ousey 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.
PubMed 29131754Benson 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.
PubMed 22546733
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Warmed Irrigation Fluid on Immediate Post-operative Pain Scores in Patients Undergoing Hip Arthroscopy
- ClinicalTrials.gov ID
- NCT03453866
- Acronym / sponsor ID
- 17-2399
- Conditions
- Femoro Acetabular Impingement, Pain, Postoperative
- Keywords
- Hip Arthroscopy, Warmed Fluids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 5 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Warmed Arthroscopic Fluids | Experimental | Procedure: Warmed Arthroscopic FluidsArthroscopic Fluids will be warmed to 38 degrees Celsius during procedure with active warming device. Temperature will be measured in real time. |
| Room Temperature Arthroscopic Fluids | Active comparator | Procedure: Room Temperature Arthroscopic FluidsArthroscopic fluids will be kept at room temperature and will not be warmed per current standard of care. Temperature will be measured in real time. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warmed Arthroscopic FluidsWarmed Arthroscopic Fluids | Procedure or surgery | Warmed Arthroscopic Fluids |
| Room Temperature Arthroscopic FluidsRoom Temperature Arthroscopic Fluids | Procedure or surgery | Room Temperature Arthroscopic Fluids |
Primary outcome
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.
2 secondary outcomes
Changes in Temperature
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Background: PubMed 28948037Truntzer 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.
- Background: PubMed 22117260Stafford 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.
- Background: PubMed 29217304Steelman 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.
- Background: PubMed 29131754Ousey 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.
- Background: PubMed 22546733Benson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Genuario, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warmed Arthroscopic Fluids and Room Temperature Arthroscopic Fluids in people with Femoro Acetabular Impingement and Pain, Postoperative, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Visual Analog Score (time frame: Pre-operatively, 30 and 60 minutes after completion of surgery, Post Op Days 1 and 14.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03453866, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.