Hip DiseasePhase 3NCT03432650
Evaluation of Anterior Quadratus Lumborum Block for Postoperative Analgesia in Hip Arthroscopy
A Phase 3 study testing Bupivacaine + dexamethasone and Ultrasound in people with Hip Disease, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Hip arthroscopy is performed frequently and the postoperative course often involves moderate to severe pain. There remains no definitive perioperative pain regimen that has been proven to be effective and safe for this ambulatory procedure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hip Disease
- What is being tested?
- Bupivacaine + dexamethasone and Ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 9 Sep 2021
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for hip arthroscopy
- Ability to follow study protocol
- English Speaking
Who cannot join
- Hepatic or renal insufficiency
- Younger than 18 years old and older than 80
- Allergy or intolerance to one of the study medications
- Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- Chronic opioid use (daily opioids use for longer than 3 months)
- Patients contraindicated to undergo a spinal anesthetic
- Non English Speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of Special Surgery
New York, New York, 10021
About this study
Official title: Evaluation of Anterior Quadratus Lumborum Block for Postoperative Analgesia in Hip Arthroscopy: A Double-Blinded Randomized Controlled Trial
Hip arthroscopy is performed frequently and the postoperative course often involves moderate to severe pain. There remains no definitive perioperative pain regimen that has been proven to be effective and safe for this ambulatory procedure. Some institutions perform peripheral nerve blocks either preoperatively or postoperatively as a rescue block. All of these PNBs lead to quadriceps weakness which may impede earlier mobilization and physical therapy. While some case reports exist, there have not been any studies evaluating the QLB for hip arthroscopy patients. As previously mentioned, the technique is easy to perform, well-tolerated by patients, and avoids side effects such as hypotension, urinary retention, or the quadriceps weakness associated with lumbar plexus blockade.
- Conditions
- Hip Disease
- Being tested
- Bupivacaine + dexamethasone, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine + dexamethasoneDrug
Anesthetic that will help treat pain and sensation after hip arthroscopy
UltrasoundDevice
Ultrasound will help guide the anesthesiologist in performing the nerve block
| Study group | Role | What they receive |
|---|---|---|
| QLB Block + Standard of Care | Experimental | Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.
Patients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone). Receives: Drug: Bupivacaine + dexamethasone; Device: Ultrasound |
| Standard of Care | No intervention | Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating System (NRS) Pain Scores
Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.
Measured: 30min after Post Anesthesia Care Unite (PACU) arrival
Numerical Pain Rating System (NRS) Pain Scores
Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.
Measured: 1 hour after Post Anesthesia Care Unite (PACU) arrival
Numerical Pain Rating System (NRS) Pain Scores
Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.
Measured: 2 hours after Post Anesthesia Care Unite (PACU) arrival
Numerical Pain Rating System (NRS) Pain Scores
Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.
Measured: 3 hours after Post Anesthesia Care Unite (PACU) arrival
Numerical Pain Rating System (NRS) Pain Scores
Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.
Measured: 24 hours after Post Anesthesia Care Unite (PACU) arrival
Secondary outcomes (10)
Opioid Use
Amount of opioids taken after surgery
Measured: After Surgery to Post Operative Day 1
Number of Patients With Presence of IAFE (Intraabdominal Fluid Extravasation) Following Surgery
Measured: Immediately post-op in OR
Number of Patients With Nausea/Vomiting
Measured: Up to Post Op Day 1
Antiemetic Use
Measured: Up to Post Op Day 1
Number of Participants With Hospital Admission
Measured: Up to Post Op Day 1
Patient Satisfaction With Post Op Pain Control
Scale of 0-10; 0 being extremely dissatisfied and 10 being extremely satisfied
Measured: Up to Post Op Day 1
Patient Score on Quality of Recovery-40 (QoR40) Inventory.
Validated QoR40 survey score. Survey questions are added up to provide a final score. Higher score is reflective of a better outcome. Minimum score is 40, maximum score is 200.
Measured: Up to Post Op Day 1
Change in Quadriceps Motor Strength on Surgical Side
Change in Quadriceps Motor Strength from Pre-Op Baseline Quadriceps Strength
Measured: Up to Post Op Day 1
Urinary Retention
Incidence of Urinary Retention in recovery
Measured: Up to Post Op Day 1
Incidence of Hypotension
Measured: Up to Post Op Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start1 Jun 2018
- Primary completion20 Dec 2020
- Study completion9 Sep 2021
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.
- Other trials for Hip DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Haskins, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432650
- Sponsor's protocol ID
- 2018-0647
- Status last verified
- Jul 2022
- First submitted
- 25 Jan 2018
- Last updated
- 19 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anterior Quadratus Lumborum Block for Postoperative Analgesia in Hip Arthroscopy: A Double-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03432650
- Acronym / sponsor ID
- 2018-0647
- Conditions
- Hip Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Posted 19 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hip arthroscopy is performed frequently and the postoperative course often involves moderate to severe pain. There remains no definitive perioperative pain regimen that has been proven to be effective and safe for this ambulatory procedure. Some institutions perform peripheral nerve blocks either preoperatively or postoperatively as a rescue block. All of these PNBs lead to quadriceps weakness which may impede earlier mobilization and physical therapy. While some case reports exist, there have not been any studies evaluating the QLB for hip arthroscopy patients. As previously mentioned, the technique is easy to perform, well-tolerated by patients, and avoids side effects such as hypotension, urinary retention, or the quadriceps weakness associated with lumbar plexus blockade.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLB Block + Standard of Care | Experimental | Drug: Bupivacaine + dexamethasone, Device: UltrasoundPatients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given. Patients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone). |
| Standard of Care | No intervention | –Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for hip arthroscopy
- Ability to follow study protocol
- English Speaking
Key exclusion criteria (7 listed)
- Hepatic or renal insufficiency
- Younger than 18 years old and older than 80
- Allergy or intolerance to one of the study medications
- Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- Chronic opioid use (daily opioids use for longer than 3 months)
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 |
|---|---|---|
| Bupivacaine + dexamethasoneAnesthetic that will help treat pain and sensation after hip arthroscopy | Drug | QLB Block + Standard of Care |
| UltrasoundUltrasound will help guide the anesthesiologist in performing the nerve block | Device | QLB Block + Standard of Care |
Primary outcome
Numerical Pain Rating System (NRS) Pain Scores
Time frame: 30min after Post Anesthesia Care Unite (PACU) arrival
Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.
Numerical Pain Rating System (NRS) Pain Scores
Time frame: 1 hour after Post Anesthesia Care Unite (PACU) arrival
Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.
Numerical Pain Rating System (NRS) Pain Scores
Time frame: 2 hours after Post Anesthesia Care Unite (PACU) arrival
Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.
Numerical Pain Rating System (NRS) Pain Scores
Time frame: 3 hours after Post Anesthesia Care Unite (PACU) arrival
Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.
Numerical Pain Rating System (NRS) Pain Scores
Time frame: 24 hours after Post Anesthesia Care Unite (PACU) arrival
Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.
10 secondary outcomes
Opioid Use
Time frame: After Surgery to Post Operative Day 1
Number of Patients With Presence of IAFE (Intraabdominal Fluid Extravasation) Following Surgery
Time frame: Immediately post-op in OR
Number of Patients With Nausea/Vomiting
Time frame: Up to Post Op Day 1
Antiemetic Use
Time frame: Up to Post Op Day 1
Number of Participants With Hospital Admission
Time frame: Up to Post Op Day 1
Patient Satisfaction With Post Op Pain Control
Time frame: Up to Post Op Day 1
Patient Score on Quality of Recovery-40 (QoR40) Inventory.
Time frame: Up to Post Op Day 1
Change in Quadriceps Motor Strength on Surgical Side
Time frame: Up to Post Op Day 1
Urinary Retention
Time frame: Up to Post Op Day 1
Incidence of Hypotension
Time frame: Up to Post Op Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hip Disease
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
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Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
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.
Stephen Haskins, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine + dexamethasone and Ultrasound in people with Hip Disease, run by Hospital for Special Surgery, New York 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: finished, as of the sponsor's last update on 19 Aug 2022. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2022). 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?
Numerical Pain Rating System (NRS) Pain Scores (time frame: 30min after Post Anesthesia Care Unite (PACU) arrival). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2022.