Femoroacetabular ImpingementPhase 4NCT03506620
The Role of Nerve Blocks in Hip Arthroscopy
A Phase 4 study testing Ropivacaine injection and Saline Solution for Injection in people with Femoroacetabular Impingement, run by Columbia University.
Trial summary
The goal of this study is to determine whether QL blocks reduce opioid consumption following arthroscopic hip surgery by decreasing postoperative pain. Considering the current opioid epidemic, the responsibility of physicians to help prevent addiction, and the increasing prevalence of arthroscopic hip surgeries, this… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- Ropivacaine injection and Saline Solution for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to 7 Feb 2020
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to receive unilateral arthroscopy hip surgery at Columbia University Medical Center with Dr. Lynch.
Who cannot join
- Patients scheduled to receive bilaterally or staged hip arthroscopy.
- Patients unwilling to participate in the research.
- History of chronic opioid use.
- Contraindication or allergy to study medications, such as QL block.
About this study
The goal of this study is to determine whether QL blocks reduce opioid consumption following arthroscopic hip surgery by decreasing postoperative pain. Considering the current opioid epidemic, the responsibility of physicians to help prevent addiction, and the increasing prevalence of arthroscopic hip surgeries, this study holds a tremendous potential benefit for future patients.
Read the detailed description
The popularity of arthroscopic hip surgery has increased greatly over the last 10 years, particularly for correcting Femoroacetabular Impingement (FAI). FAI is a structural abnormality of the proximal femur, the acetabulum, or both. It is a leading cause of labral tears in the hip joint and can cause cartilage damage, which may increase subsequent risk of developing osteoarthritis. Though far less invasive than open hip surgery such as for a total hip replacement, hip arthroscopy can cause significant postoperative pain for the patient. Given how relatively new the procedure still is, methods of pain control are highly variable. Peripheral nerve blocks, mainly femoral nerve and lumbar plexus blocks, have been used by some surgeons to control postoperative pain. However, in addition to their sensory effects, these blocks cause motor impairment that has been associated with a significantly higher risk of falling.
In managing pain after any operation, opioid consumption is, of course, a significant concern. Ideally, hip arthroscopy patients could receive a peripheral nerve block that decreases pain and the need for opioids, but without the muscular weakness and increased fall risk observed with femoral nerve and lumbar plexus blocks. This may be achievable with the newer Quadratus Lumborum (QL) block.
The ultrasound-guided QL block is currently most commonly used for abdominal surgery.
However, several case studies of a single-injection QL block in hip replacement surgeries have been successful in minimizing pain and opioid use while sparing motor function and avoiding the muscle weakness that can lead to falls. In the approach utilized in these cases, local anesthetic was injected at the anterolateral border of the QL muscle to achieve analgesia ranging from the T6-T10 through L3 dermatomes. One group has anecdotally reported great success in using these QL blocks for alleviating postoperative pain with hip arthroscopy, but no studies to date have evaluated the effectiveness of QL blocks for arthroscopic hip surgery.
This study is a randomized, controlled, double-blind trial. Patients undergoing hip arthroscopy who agree to participate will be randomly selected to receive an ultrasound-guided QL block with either local anesthetic (QL block group) or normal saline (control group) preoperatively.
After surgery and during the first postoperative week, patients will record their numerical pain score, the location of their pain, and their opioid consumption using our attached study instrument. On this form, they will record their pain score at 0.5, 1, 1.5, 2, 4, 6, 12, 24, and 48 hours and 7 days after surgery. The form specifies that if patients are unable to record their pain score at any of these time points, particularly because they are sleeping/recovering, they can simply skip that time point. For pain location, patients are instructed to draw X's on a standard cartoon at the site of their pain. For opioid consumption, patients simply record when and how many pills they take. This form will be collected from patients at their 10-14 day postoperative visit. Data will also be collected from the medical chart on time to discharge and any complications in the perioperative period. Questionnaires will be used to assess pain, physical and social health, such as Patient-Reported Outcomes Measurement Information System (PROMIS).
- Conditions
- Femoroacetabular Impingement
- Being tested
- Ropivacaine injection, Saline Solution for Injection
- Keywords
- femoroacetabular impingement, hip arthroscopy, QL nerve block
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine injectionDrug
Also called Naropin
Naropin (Ropivacaine HCl) 0.25%; Dose: 20 cc
Saline Solution for InjectionDrug
Also called Normal Saline
20 cc of saline will be injected in the form of a QL block as a placebo.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Subjects will be randomized to receive a single-injection QL block with normal saline (Saline Solution for Injection). Receives: Drug: Saline Solution for Injection |
| QL Block | Experimental | Subjects will be randomized to receive a single-injection QL block with either local anesthetic (0.25% Ropivacaine injection). Receives: Drug: Ropivacaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Measured: 0.5 hour
Pain Score
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Measured: 1 hour
Pain Score
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Measured: 1.5 hours
Pain Score
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Measured: 2 hours
Pain Score
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Measured: 4 hours
Pain Score
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Measured: 6 hours
Pain Score
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Measured: 12 hours
Pain Score
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Measured: 24 hours
Pain Score
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Measured: 48 hours
Pain Score
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Measured: 7 days
Oral Morphine Equivalents
Opioid consumption following surgery as self reported by patients, measured in mg
Measured: 24 hours after surgery
Oral Morphine Equivalents
Opioid consumption following surgery as self reported by patients, measured in mg
Measured: 48 hours after surgery
Oral Morphine Equivalents
Opioid consumption following surgery as self reported by patients, measured in mg
Measured: 7 days after surgery
Patient Satisfaction Score
Patients will record their satisfaction following surgery on a scale of 0-10 (0 being not satisfied, 10 being fully satisfied)
Measured: 24 hours after surgery
Patient Satisfaction Score
Patients will record their satisfaction following surgery on a scale of 0-10 (0 being not satisfied, 10 being fully satisfied)
Measured: 48 hours after surgery
Patient Satisfaction Score
Patients will record their satisfaction following surgery on a scale of 0-10 (0 being not satisfied, 10 being fully satisfied)
Measured: 7 days after surgery
Percentage of Patients Reporting Nausea and/or Vomiting
Patients will self report any instances of nausea and/or vomiting
Measured: 24 hours after surgery
Percentage of Patients Reporting Nausea and/or Vomiting
Patients will self report any instances of nausea and/or vomiting
Measured: 48 hours after surgery
Percentage of Patients Reporting Nausea and/or Vomiting
Patients will self report any instances of nausea and/or vomiting
Measured: 7 days after surgery
Secondary outcomes (32)
HOS-ADL Questionnaire Score
Hip Outcome Survey (HOS) is a self-administered questionnaire with a scoring system composed of 2 sub-scales - a rating tool to assess a patient's level of ability. Activities of Daily Living (ADL) sub-scale made of 19 items. Scales are scored from 0 to 4, with 0 being 'unable to do' and 4, 'no difficulty'. The average of the total scores of the patients in each arm will be provided.
Measured: Baseline preoperative
HOS-ADL Questionnaire Score
Hip Outcome Survey (HOS) is a self-administered questionnaire with a scoring system composed of 2 sub-scales - a rating tool to assess a patient's level of ability. Activities of Daily Living (ADL) sub-scale made of 19 items. Scales are scored from 0 to 4, with 0 being 'unable to do' and 4, 'no difficulty'. The average of the total scores of the patients in each arm will be provided.
Measured: 2 weeks after surgery
mHHS Questionnaire Score
Modified Harris Hip Score (mHHS) is made up of 8 questions - a rating tool to assess how you are doing before and after surgery. The score is reported as 90-100 for excellent results, 80-89 being good, 70-79 fair, 60-69 poor, and below 60 a failed result.The average of the total scores of the patients in each arm will be provided.
Measured: Baseline preoperative
mHHS Questionnaire Score
Modified Harris Hip Score (mHHS) is made up of 8 questions - a rating tool to assess how you are doing before and after surgery. The score is reported as 90-100 for excellent results, 80-89 being good, 70-79 fair, 60-69 poor, and below 60 a failed result.The average of the total scores of the patients in each arm will be provided.
Measured: 2 weeks after surgery
HOOS - Symptoms and Stiffness Questionnaire Score
A 40 item questionnaire (hip disability and osteoarthritis outcome score, HOOS) to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. The average of the total scores of the patients in each arm will be provided.
Measured: Baseline preoperatively
HOOS - Symptoms and Stiffness Questionnaire Score
A 40 item questionnaire (hip disability and osteoarthritis outcome score, HOOS) to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. The average of the total scores of the patients in each arm will be provided.
Measured: 2 weeks after surgery
HOOS - ADL Questionnaire Score
A 40 item questionnaire (hip disability and osteoarthritis outcome score, HOOS) to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included.This subscale: Activities of Daily Living. The average of the total scores of the patients in each arm will be provided.
Measured: Baseline preoperatively
HOOS - ADL Questionnaire Score
A 40 item questionnaire (hip disability and osteoarthritis outcome score, HOOS) to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included.This subscale: Activities of Daily Living. The average of the total scores of the patients in each arm will be provided.
Measured: 2 weeks after surgery
HOOS - Sports Questionnaire Score
HOOS will be used to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. This subscale: Sport and Recreation Function (SP) (four items). The average of the total scores of the patients in each arm will be provided.
Measured: Baseline preoperatively
HOOS - Sports Questionnaire Score
HOOS will be used to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. This subscale: Sport and Recreation Function (SP) (four items). The average of the total scores of the patients in each arm will be provided.
Measured: 2 weeks after surgery
HOOS - Quality of Life Questionnaire Score
HOOS will be used to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. This subscale: Hip Related Quality of Life (Q) (four items). The average of the total scores of the patients in each arm will be provided.
Measured: Baseline preoperatively
HOOS - Quality of Life Questionnaire Score
HOOS will be used to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. This subscale: Hip Related Quality of Life (Q) (four items). The average of the total scores of the patients in each arm will be provided.
Measured: 2 weeks after surgery
UCLA Activity Score Questionnaire Score
University of California, Los Angeles (UCLA) activity scale is a simple scale ranging from 1 to 10. The patient indicates her or his most appropriate activity level, with 1 defined as "no physical activity, dependent on others" and 10 defined as "regular participation in impact sports." The average of the total scores of the patients in each arm will be provided.
Measured: Baseline preoperatively
UCLA Activity Score Questionnaire Score
University of California, Los Angeles (UCLA) activity scale is a simple scale ranging from 1 to 10. The patient indicates her or his most appropriate activity level, with 1 defined as "no physical activity, dependent on others" and 10 defined as "regular participation in impact sports." The average of the total scores of the patients in each arm will be provided.
Measured: 2 weeks after surgery
VR-12 Mental Health Questionnaire Score
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, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items are summarized into two scores, one for mental health and one for physical health. The average of the total scores of the patients in each arm will be provided.
Measured: Baseline preoperatively
VR-12 Mental Health Questionnaire Score
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, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items are summarized into two scores, one for mental health and one for physical health. The average of the total scores of the patients in each arm will be provided.
Measured: 2 weeks after surgery
VR-12 Physical Health Questionnaire Score
VR-12 will be used to measure health-related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items are summarized into two scores, one for mental health and one for physical health.The average of the total scores of the patients in each arm will be provided.
Measured: Baseline preoperatively
VR-12 Physical Health Questionnaire Score
VR-12 will be used to measure health-related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items are summarized into two scores, one for mental health and one for physical health.The average of the total scores of the patients in each arm will be provided.
Measured: 2 weeks after surgery
HOOS - Short Form Total Score Questionnaire Score
HOOS will be used to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. The average of the total scores of the patients in each arm will be provided.
Measured: Baseline preoperatively
HOOS - Short Form Total Score Questionnaire Score
HOOS will be used to assess patient-relevant outcomes in five separate subscales. To answer each question, five Likert-boxes were used (no, mild, moderate, severe, extreme). All items were scored from zero to four, and each of the five subscales was calculated as the sum of the items included. The average of the total scores of the patients in each arm will be provided.
Measured: 2 weeks after surgery
iHOT-12 Questionnaire Score
A Short Version of the International Hip Outcome Tool (iHOT-12) self administered outcome measure based on a Visual Analogue Scale response format designed for young and active population with hip pathology. The average of the total scores of the patients in each arm will be provided.
Measured: Baseline preoperatively
iHOT-12 Questionnaire Score
A Short Version of the International Hip Outcome Tool (iHOT-12) self administered outcome measure based on a Visual Analogue Scale response format designed for young and active population with hip pathology. The average of the total scores of the patients in each arm will be provided.
Measured: 2 weeks after surgery
PROMIS v1.1 Pain Interference Questionnaire Score
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health. The Pain Interference Questionnaire is comprised of 56 items, total score will be calculated. PROMIS is a computer adaptive test with branching logic. To answer each question, five Likert-boxes were used. The average of the total scores of the patients in each arm will be provided.
Measured: Baseline preoperatively
PROMIS v1.1 Pain Interference Questionnaire Score
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health. The Pain Interference Questionnaire is comprised of 56 items, total score will be calculated. PROMIS is a computer adaptive test with branching logic. To answer each question, five Likert-boxes were used. The average of the total scores of the patients in each arm will be provided.
Measured: 2 weeks after surgery
PROMIS v1.0 Pain Intensity 3a Questionnaire Score
PROMIS is a computer adaptive test with branching logic. The Pain Intensity Questionnaire is comprised of 3 items, total score will be calculated. To answer each question, five Likert-boxes were used (no pain, mild, moderate, severe, very severe). The average of the total scores of the patients in each arm will be provided.
Measured: Baseline preoperatively
PROMIS v1.0 Pain Intensity 3a Questionnaire Score
PROMIS is a computer adaptive test with branching logic. The Pain Intensity Questionnaire is comprised of 3 items, total score will be calculated. To answer each question, five Likert-boxes were used (no pain, mild, moderate, severe, very severe). The average of the total scores of the patients in each arm will be provided.
Measured: 2 weeks after surgery
PROMIS v1.2 Physical Function Questionnaire Score
PROMIS is a computer adaptive test with branching logic. The Physical Function Questionnaire is comprised of 170 items, total score will be calculated. To answer each question, five Likert-boxes were used (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). The average of the total scores of the patients in each arm will be provided.
Measured: Baseline preoperatively
PROMIS v1.2 Physical Function Questionnaire Score
PROMIS is a computer adaptive test with branching logic. The Physical Function Questionnaire is comprised of 170 items, total score will be calculated. To answer each question, five Likert-boxes were used (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). The average of the total scores of the patients in each arm will be provided.
Measured: 2 weeks after surgery
PROMIS v2.0 Ability to Participate Socially Questionnaire Score
PROMIS is a computer adaptive test with branching logic. The Ability to Participate Socially Questionnaire is comprised of 35 items, total score will be calculated. To answer each question, five Likert-boxes were used (never, rarely, sometimes, usually, always). The average of the total scores of the patients in each arm will be provided.
Measured: Baseline preoperatively
PROMIS v2.0 Ability to Participate Socially Questionnaire Score
PROMIS is a computer adaptive test with branching logic. The Ability to Participate Socially Questionnaire is comprised of 35 items, total score will be calculated. To answer each question, five Likert-boxes were used (never, rarely, sometimes, usually, always). The average of the total scores of the patients in each arm will be provided.
Measured: 2 weeks after surgery
PROMIS v2.0 Satisfaction with Roles and Activities Questionnaire Score
PROMIS is a computer adaptive test with branching logic. The Ability to Participate Socially Questionnaire is comprised of 44 items, total score will be calculated. To answer each question, five Likert-boxes were used (not at all, a little bit, somewhat, quite a bit, very much). The average of the total scores of the patients in each arm will be provided.
Measured: Baseline preoperatively
PROMIS v2.0 Satisfaction with Roles and Activities Questionnaire Score
PROMIS is a computer adaptive test with branching logic. The Ability to Participate Socially Questionnaire is comprised of 44 items, total score will be calculated. To answer each question, five Likert-boxes were used (not at all, a little bit, somewhat, quite a bit, very much). The average of the total scores of the patients in each arm will be provided.
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study startJan 2019 (estimated)
- Primary completion7 Feb 2020
- Study completion7 Feb 2020
Why it stopped: Unforeseen cost restrictions of the drug halted the execution of this study altogether.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized, controlled, double-blind trial. Patients undergoing hip arthroscopy who agree to participate will be randomly selected to receive an ultrasound-guided QL block with either local anesthetic (QL block group) or normal saline (control group) preoperatively.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Lynch, Columbia University
- Investigators
- Thomas S Lynch, M.D., Principal investigator, Columbia University Department of Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506620
- Sponsor's protocol ID
- AAAR7247
- Status last verified
- May 2020
- First submitted
- 13 Apr 2018
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
La Colla L, Ben-David B, Merman R. Quadratus Lumborum Block as an Alternative to Lumbar Plexus Block for Hip Surgery: A Report of 2 Cases. A A Case Rep. 2017 Jan 1;8(1):4-6. doi: 10.1213/XAA.0000000000000406.
PubMed 28036319La Colla L, Uskova A, Ben-David B. Single-shot Quadratus Lumborum Block for Postoperative Analgesia After Minimally Invasive Hip Arthroplasty: A New Alternative to Continuous Lumbar Plexus Block? Reg Anesth Pain Med. 2017 Jan/Feb;42(1):125-126. doi: 10.1097/AAP.0000000000000523. No abstract available.
PubMed 27997495Ben-David B, La Colla L. Extravasated Fluid in Hip Arthroscopy and Pain: Is Quadratus Lumborum Block the Answer? Anesth Analg. 2017 Jul;125(1):364. doi: 10.1213/ANE.0000000000002198. No abstract available.
PubMed 28609336
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Nerve Blocks in Hip Arthroscopy
- ClinicalTrials.gov ID
- NCT03506620
- Acronym / sponsor ID
- AAAR7247
- Conditions
- Femoroacetabular Impingement
- Keywords
- femoroacetabular impingement, hip arthroscopy, QL nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unforeseen cost restrictions of the drug halted the execution of this study altogether.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 24 Apr 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 goal of this study is to determine whether QL blocks reduce opioid consumption following arthroscopic hip surgery by decreasing postoperative pain. Considering the current opioid epidemic, the responsibility of physicians to help prevent addiction, and the increasing prevalence of arthroscopic hip surgeries, this study holds a tremendous potential benefit for future patients.
Detailed description
The popularity of arthroscopic hip surgery has increased greatly over the last 10 years, particularly for correcting Femoroacetabular Impingement (FAI). FAI is a structural abnormality of the proximal femur, the acetabulum, or both. It is a leading cause of labral tears in the hip joint and can cause cartilage damage, which may increase subsequent risk of developing osteoarthritis. Though far less invasive than open hip surgery such as for a total hip replacement, hip arthroscopy can cause significant postoperative pain for the patient. Given how relatively new the procedure still is, methods of pain control are highly variable. Peripheral nerve blocks, mainly femoral nerve and lumbar plexus blocks, have been used by some surgeons to control postoperative pain. However, in addition to their sensory effects, these blocks cause motor impairment that has been associated with a significantly higher risk of falling.
In managing pain after any operation, opioid consumption is, of course, a significant concern. Ideally, hip arthroscopy patients could receive a peripheral nerve block that decreases pain and the need for opioids, but without the muscular weakness and increased fall risk observed with femoral nerve and lumbar plexus blocks. This may be achievable with the newer Quadratus Lumborum (QL) block.
The ultrasound-guided QL block is currently most commonly used for abdominal surgery.
However, several case studies of a single-injection QL block in hip replacement surgeries have been successful in minimizing pain and opioid use while sparing motor function and avoiding the muscle weakness that can lead to falls. In the approach utilized in these cases, local anesthetic was injected at the anterolateral border of the QL muscle to achieve analgesia ranging from the T6-T10 through L3 dermatomes. One group has anecdotally reported great success in using these QL blocks for alleviating postoperative pain with hip arthroscopy, but no studies to date have evaluated the effectiveness of QL blocks for arthroscopic hip surgery.
This study is a randomized, controlled, double-blind trial. Patients undergoing hip arthroscopy who agree to participate will be randomly selected to receive an ultrasound-guided QL block with either local anesthetic (QL block group) or normal saline (control group) preoperatively.
After surgery and during the first postoperative week, patients will record their numerical pain score, the location of their pain, and their opioid consumption using our attached study instrument. On this form, they will record their pain score at 0.5, 1, 1.5, 2, 4, 6, 12, 24, and 48 hours and 7 days after surgery. The form specifies that if patients are unable to record their pain score at any of these time points, particularly because they are sleeping/recovering, they can simply skip that time point. For pain location, patients are instructed to draw X's on a standard cartoon at the site of their pain. For opioid consumption, patients simply record when and how many pills they take. This form will be collected from patients at their 10-14 day postoperative visit. Data will also be collected from the medical chart on time to discharge and any complications in the perioperative period. Questionnaires will be used to assess pain, physical and social health, such as Patient-Reported Outcomes Measurement Information System (PROMIS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This study is a randomized, controlled, double-blind trial. Patients undergoing hip arthroscopy who agree to participate will be randomly selected to receive an ultrasound-guided QL block with either local anesthetic (QL block group) or normal saline (control group) preoperatively.
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Saline Solution for InjectionSubjects will be randomized to receive a single-injection QL block with normal saline (Saline Solution for Injection). |
| QL Block | Experimental | Drug: Ropivacaine injectionSubjects will be randomized to receive a single-injection QL block with either local anesthetic (0.25% Ropivacaine injection). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled to receive unilateral arthroscopy hip surgery at Columbia University Medical Center with Dr. Lynch.
Key exclusion criteria (4 listed)
- Patients scheduled to receive bilaterally or staged hip arthroscopy.
- Patients unwilling to participate in the research.
- History of chronic opioid use.
- Contraindication or allergy to study medications, such as QL block.
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 |
|---|---|---|
| Ropivacaine injectionAlso: NaropinNaropin (Ropivacaine HCl) 0.25%; Dose: 20 cc | Drug | QL Block |
| Saline Solution for InjectionAlso: Normal Saline20 cc of saline will be injected in the form of a QL block as a placebo. | Drug | Control |
Primary outcome
Pain Score
Time frame: 0.5 hour
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Pain Score
Time frame: 1 hour
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Pain Score
Time frame: 1.5 hours
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Pain Score
Time frame: 2 hours
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Pain Score
Time frame: 4 hours
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Pain Score
Time frame: 6 hours
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Pain Score
Time frame: 12 hours
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Pain Score
Time frame: 24 hours
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Pain Score
Time frame: 48 hours
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Pain Score
Time frame: 7 days
Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)
Oral Morphine Equivalents
Time frame: 24 hours after surgery
Opioid consumption following surgery as self reported by patients, measured in mg
Oral Morphine Equivalents
Time frame: 48 hours after surgery
Opioid consumption following surgery as self reported by patients, measured in mg
Oral Morphine Equivalents
Time frame: 7 days after surgery
Opioid consumption following surgery as self reported by patients, measured in mg
Patient Satisfaction Score
Time frame: 24 hours after surgery
Patients will record their satisfaction following surgery on a scale of 0-10 (0 being not satisfied, 10 being fully satisfied)
Patient Satisfaction Score
Time frame: 48 hours after surgery
Patients will record their satisfaction following surgery on a scale of 0-10 (0 being not satisfied, 10 being fully satisfied)
Patient Satisfaction Score
Time frame: 7 days after surgery
Patients will record their satisfaction following surgery on a scale of 0-10 (0 being not satisfied, 10 being fully satisfied)
Percentage of Patients Reporting Nausea and/or Vomiting
Time frame: 24 hours after surgery
Patients will self report any instances of nausea and/or vomiting
Percentage of Patients Reporting Nausea and/or Vomiting
Time frame: 48 hours after surgery
Patients will self report any instances of nausea and/or vomiting
Percentage of Patients Reporting Nausea and/or Vomiting
Time frame: 7 days after surgery
Patients will self report any instances of nausea and/or vomiting
32 secondary outcomes
HOS-ADL Questionnaire Score
Time frame: Baseline preoperative
HOS-ADL Questionnaire Score
Time frame: 2 weeks after surgery
mHHS Questionnaire Score
Time frame: Baseline preoperative
mHHS Questionnaire Score
Time frame: 2 weeks after surgery
HOOS - Symptoms and Stiffness Questionnaire Score
Time frame: Baseline preoperatively
HOOS - Symptoms and Stiffness Questionnaire Score
Time frame: 2 weeks after surgery
HOOS - ADL Questionnaire Score
Time frame: Baseline preoperatively
HOOS - ADL Questionnaire Score
Time frame: 2 weeks after surgery
HOOS - Sports Questionnaire Score
Time frame: Baseline preoperatively
HOOS - Sports Questionnaire Score
Time frame: 2 weeks after surgery
HOOS - Quality of Life Questionnaire Score
Time frame: Baseline preoperatively
HOOS - Quality of Life Questionnaire Score
Time frame: 2 weeks after surgery
UCLA Activity Score Questionnaire Score
Time frame: Baseline preoperatively
UCLA Activity Score Questionnaire Score
Time frame: 2 weeks after surgery
VR-12 Mental Health Questionnaire Score
Time frame: Baseline preoperatively
VR-12 Mental Health Questionnaire Score
Time frame: 2 weeks after surgery
VR-12 Physical Health Questionnaire Score
Time frame: Baseline preoperatively
VR-12 Physical Health Questionnaire Score
Time frame: 2 weeks after surgery
HOOS - Short Form Total Score Questionnaire Score
Time frame: Baseline preoperatively
HOOS - Short Form Total Score Questionnaire Score
Time frame: 2 weeks after surgery
iHOT-12 Questionnaire Score
Time frame: Baseline preoperatively
iHOT-12 Questionnaire Score
Time frame: 2 weeks after surgery
PROMIS v1.1 Pain Interference Questionnaire Score
Time frame: Baseline preoperatively
PROMIS v1.1 Pain Interference Questionnaire Score
Time frame: 2 weeks after surgery
PROMIS v1.0 Pain Intensity 3a Questionnaire Score
Time frame: Baseline preoperatively
PROMIS v1.0 Pain Intensity 3a Questionnaire Score
Time frame: 2 weeks after surgery
PROMIS v1.2 Physical Function Questionnaire Score
Time frame: Baseline preoperatively
PROMIS v1.2 Physical Function Questionnaire Score
Time frame: 2 weeks after surgery
PROMIS v2.0 Ability to Participate Socially Questionnaire Score
Time frame: Baseline preoperatively
PROMIS v2.0 Ability to Participate Socially Questionnaire Score
Time frame: 2 weeks after surgery
PROMIS v2.0 Satisfaction with Roles and Activities Questionnaire Score
Time frame: Baseline preoperatively
PROMIS v2.0 Satisfaction with Roles and Activities Questionnaire Score
Time frame: 2 weeks after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Background: PubMed 28036319La Colla L, Ben-David B, Merman R. Quadratus Lumborum Block as an Alternative to Lumbar Plexus Block for Hip Surgery: A Report of 2 Cases. A A Case Rep. 2017 Jan 1;8(1):4-6. doi: 10.1213/XAA.0000000000000406.
- Background: PubMed 27997495La Colla L, Uskova A, Ben-David B. Single-shot Quadratus Lumborum Block for Postoperative Analgesia After Minimally Invasive Hip Arthroplasty: A New Alternative to Continuous Lumbar Plexus Block? Reg Anesth Pain Med. 2017 Jan/Feb;42(1):125-126. doi: 10.1097/AAP.0000000000000523. No abstract available.
- Background: PubMed 28609336Ben-David B, La Colla L. Extravasated Fluid in Hip Arthroscopy and Pain: Is Quadratus Lumborum Block the Answer? Anesth Analg. 2017 Jul;125(1):364. doi: 10.1213/ANE.0000000000002198. No abstract available.
- 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.
Thomas S Lynch, M.D. principal investigator
Columbia University Department of Orthopedics
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine injection and Saline Solution for Injection in people with Femoroacetabular Impingement, run by Columbia University.
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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 Score (time frame: 0.5 hour). The study lists 19 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 NCT03506620, which also lists 3 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 20 May 2020.