Internal Derangement of HipNCT01997567
Preemptive Femoral & Lateral Femoral Cutaneous Nerve Blocks for THA Acute Pain
A study testing Ropivacaine in people with Internal Derangement of Hip and Acetabular Labrum Tear, run by Rush University Medical Center at 1 site in United States.
Trial summary
The goal of the study is to evaluate via a prospective, blinded, randomized clinical trial, whether ultrasound-guided single femoral and lateral femoral cutaneous nerve blocks with ropivacaine 0.5% with epinephrine (1:200,000) as a tracer for intravascular injection (total 30 ml) vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Internal Derangement of Hip, Acetabular Labrum Tear
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 year old,
- ASA physical status classification system score (ASA) <=3
- due to undergo elective unilateral hip arthroscopy by one surgeon Dr. Nho (Co-Principal Investigator)
Who cannot join
- ASA physical status classification system score) (ASA) >3
- history of opioid dependence or abuse
- current chronic analgesic therapy (daily use =>20 mg oxycodone-equivalent opioid use within 2 weeks before surgery and duration of use >=4 weeks)
- allergy to study medications (fentanyl and ropivicaine)
- any neuromuscular deficit of the ipsilateral femoral nerve or quadriceps femoris muscle (including diabetic peripheral neuropathy)
- diagnosis of hypertension and/or current treatment for hypertension
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Are Preemptive Femoral and Lateral Femoral Cutaneous Nerve Blocks Given Immediately Prior to Hip Arthroscopy(THA) Effective for Acute Postoperative Pain Management?
The goal of the study is to evaluate via a prospective, blinded, randomized clinical trial, whether ultrasound-guided single femoral and lateral femoral cutaneous nerve blocks with ropivacaine 0.5% with epinephrine (1:200,000) as a tracer for intravascular injection (total 30 ml) vs. saline with epinephrine (1:200,000) (total 30 ml), given just prior to same day elective hip arthroscopy, is effective in reducing acute postoperative pain (NRS scores), postoperative opiate consumption, and time to discharge from the postanesthesia care unit. Differences between groups with respect to postoperative quality of life and functional scores will also be evaluated.
Read the detailed description
The purpose of this study is to evaluate whether ultrasound (using sound waves to produce an image)-guided regional anesthesia (local numbing medicine) to the hip area given in addition to general anesthesia just prior to same day elective hip arthroscopy, is effective in reducing acute postoperative pain, and time to discharge from the post anesthesia care unit. In addition, the study aims to examine whether this regional anesthesia medication has any effect on the study subjects' use of pain medication both during and after the procedure, return to function, and quality of life in the 6 month period after the surgical procedure. Although hip arthroscopy is a routine procedure, the best method for pain control is not well established, and is the purpose of this study.
- Being tested
- Ropivacaine, Placebo
- Keywords
- Hip Arthroscopy, Regional Anesthesia, Peripheral Nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)
PlaceboDrug
Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)
| Study group | Role | What they receive |
|---|---|---|
| Grp 1 Ropivacaine Block | Active comparator | Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml) Receives: Drug: Ropivacaine |
| Grp 2 Placebo Block | Placebo comparator | Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Numerical Rating Scale Score (NRS 0-10)
The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.
Measured: Preoperative 2-8 wks
Pain Numerical Rating Scale Score (NRS 0-10)
The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.
Study was closed due to enrollment issues and data were not collected or analized.
Measured: 3 wks postoperative
Pain Numerical Rating Scale Score (NRS 0-10)
The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.
Measured: 3 months postoperative
Pain Numerical Rating Scale Score (NRS 0-10)
The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.
Measured: 6 months postoperative
Secondary outcomes (3)
Veterans Research and Development (RAND) 12 Item Health Survey (VR-12) Scores
Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.
Measured: Preoperative 2-8 wks
Veterans RAND 12 Item Health Survey (VR-12) Scores
Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.
Measured: 3 months postoperative
Veterans RAND 12 Item Health Survey (VR-12) Scores
Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Subject recruitment is too difficult and we foresee that this will not improve
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Internal Derangement of HipStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandeep Amin, MD, Rush University Medical Center
- Investigators
- Sandeep Amin, M.D., Principal investigator, Rush University Medical CenterShane Nho, M.D., M.S., Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997567
- Sponsor's protocol ID
- Hip-Scope-Block
- Status last verified
- Sep 2018
- First submitted
- 13 Jun 2013
- Last updated
- 3 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No data to Share
Publications
YaDeau JT, Tedore T, Goytizolo EA, Kim DH, Green DS, Westrick A, Fan R, Rade MC, Ranawat AS, Coleman SH, Kelly BT. Lumbar plexus blockade reduces pain after hip arthroscopy: a prospective randomized controlled trial. Anesth Analg. 2012 Oct;115(4):968-72. doi: 10.1213/ANE.0b013e318265bacd. Epub 2012 Jul 19.
PubMed 22822195Ward JP, Albert DB, Altman R, Goldstein RY, Cuff G, Youm T. Are femoral nerve blocks effective for early postoperative pain management after hip arthroscopy? Arthroscopy. 2012 Aug;28(8):1064-9. doi: 10.1016/j.arthro.2012.01.003. Epub 2012 Apr 11.
PubMed 22498045Lee EM, Murphy KP, Ben-David B. Postoperative analgesia for hip arthroscopy: combined L1 and L2 paravertebral blocks. J Clin Anesth. 2008 Sep;20(6):462-5. doi: 10.1016/j.jclinane.2008.04.012.
PubMed 18929290Good RP, Snedden MH, Schieber FC, Polachek A. Effects of a preoperative femoral nerve block on pain management and rehabilitation after total knee arthroplasty. Am J Orthop (Belle Mead NJ). 2007 Oct;36(10):554-7.
PubMed 18033568Aprato A, Jayasekera N, Villar R. Timing in hip arthroscopy: does surgical timing change clinical results? Int Orthop. 2012 Nov;36(11):2231-4. doi: 10.1007/s00264-012-1655-x. Epub 2012 Sep 11.
PubMed 22965491
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Preemptive Femoral and Lateral Femoral Cutaneous Nerve Blocks Given Immediately Prior to Hip Arthroscopy(THA) Effective for Acute Postoperative Pain Management?
- ClinicalTrials.gov ID
- NCT01997567
- Acronym / sponsor ID
- Hip-Scope-Block
- Keywords
- Hip Arthroscopy, Regional Anesthesia, Peripheral Nerve block
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Subject recruitment is too difficult and we foresee that this will not improve
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Posted 17 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to evaluate via a prospective, blinded, randomized clinical trial, whether ultrasound-guided single femoral and lateral femoral cutaneous nerve blocks with ropivacaine 0.5% with epinephrine (1:200,000) as a tracer for intravascular injection (total 30 ml) vs. saline with epinephrine (1:200,000) (total 30 ml), given just prior to same day elective hip arthroscopy, is effective in reducing acute postoperative pain (NRS scores), postoperative opiate consumption, and time to discharge from the postanesthesia care unit. Differences between groups with respect to postoperative quality of life and functional scores will also be evaluated.
Detailed description
The purpose of this study is to evaluate whether ultrasound (using sound waves to produce an image)-guided regional anesthesia (local numbing medicine) to the hip area given in addition to general anesthesia just prior to same day elective hip arthroscopy, is effective in reducing acute postoperative pain, and time to discharge from the post anesthesia care unit. In addition, the study aims to examine whether this regional anesthesia medication has any effect on the study subjects' use of pain medication both during and after the procedure, return to function, and quality of life in the 6 month period after the surgical procedure. Although hip arthroscopy is a routine procedure, the best method for pain control is not well established, and is the purpose of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grp 1 Ropivacaine Block | Active comparator | Drug: RopivacaineGroup 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml) |
| Grp 2 Placebo Block | Placebo comparator | Drug: PlaceboGroup 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 year old,
- ASA physical status classification system score (ASA) <=3
- due to undergo elective unilateral hip arthroscopy by one surgeon Dr. Nho (Co-Principal Investigator)
Key exclusion criteria (7 listed)
- ASA physical status classification system score) (ASA) >3
- history of opioid dependence or abuse
- current chronic analgesic therapy (daily use =>20 mg oxycodone-equivalent opioid use within 2 weeks before surgery and duration of use >=4 weeks)
- allergy to study medications (fentanyl and ropivicaine)
- any neuromuscular deficit of the ipsilateral femoral nerve or quadriceps femoris muscle (including diabetic peripheral neuropathy)
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 |
|---|---|---|
| RopivacaineSubjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml) | Drug | Grp 1 Ropivacaine Block |
| PlaceboGroup 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml) | Drug | Grp 2 Placebo Block |
Primary outcome
Pain Numerical Rating Scale Score (NRS 0-10)
Time frame: Preoperative 2-8 wks
The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.
Pain Numerical Rating Scale Score (NRS 0-10)
Time frame: 3 wks postoperative
The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure. Study was closed due to enrollment issues and data were not collected or analized.
Pain Numerical Rating Scale Score (NRS 0-10)
Time frame: 3 months postoperative
The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.
Pain Numerical Rating Scale Score (NRS 0-10)
Time frame: 6 months postoperative
The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.
3 secondary outcomes
Veterans Research and Development (RAND) 12 Item Health Survey (VR-12) Scores
Time frame: Preoperative 2-8 wks
Veterans RAND 12 Item Health Survey (VR-12) Scores
Time frame: 3 months postoperative
Veterans RAND 12 Item Health Survey (VR-12) Scores
Time frame: 6 months postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22822195YaDeau JT, Tedore T, Goytizolo EA, Kim DH, Green DS, Westrick A, Fan R, Rade MC, Ranawat AS, Coleman SH, Kelly BT. Lumbar plexus blockade reduces pain after hip arthroscopy: a prospective randomized controlled trial. Anesth Analg. 2012 Oct;115(4):968-72. doi: 10.1213/ANE.0b013e318265bacd. Epub 2012 Jul 19.
- Background: PubMed 22498045Ward JP, Albert DB, Altman R, Goldstein RY, Cuff G, Youm T. Are femoral nerve blocks effective for early postoperative pain management after hip arthroscopy? Arthroscopy. 2012 Aug;28(8):1064-9. doi: 10.1016/j.arthro.2012.01.003. Epub 2012 Apr 11.
- Background: PubMed 18929290Lee EM, Murphy KP, Ben-David B. Postoperative analgesia for hip arthroscopy: combined L1 and L2 paravertebral blocks. J Clin Anesth. 2008 Sep;20(6):462-5. doi: 10.1016/j.jclinane.2008.04.012.
- Background: PubMed 18033568Good RP, Snedden MH, Schieber FC, Polachek A. Effects of a preoperative femoral nerve block on pain management and rehabilitation after total knee arthroplasty. Am J Orthop (Belle Mead NJ). 2007 Oct;36(10):554-7.
- Background: PubMed 22965491Aprato A, Jayasekera N, Villar R. Timing in hip arthroscopy: does surgical timing change clinical results? Int Orthop. 2012 Nov;36(11):2231-4. doi: 10.1007/s00264-012-1655-x. Epub 2012 Sep 11.
- Individual participant dataSharing planned: No. No data to Share
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.
Sandeep Amin, M.D. principal investigator
Rush University Medical Center
Shane Nho, M.D., M.S. principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine in people with Internal Derangement of Hip and Acetabular Labrum Tear, run by Rush University Medical Center 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 3 Oct 2018. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 17 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Numerical Rating Scale Score (NRS 0-10) (time frame: Preoperative 2-8 wks). The study lists 4 primary outcomes in all. 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 NCT01997567, 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 3 Oct 2018.