A Phase 3 interventional study of Bupivacaine + dexamethasone and Ultrasound in Hip Disease, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-19.
Sponsored by Hospital for Special Surgery, New York · Phase 3, Interventional, and Treatment
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.
Hospital for Special Surgery, New York is the lead sponsor of 226 studies on the registry; 40 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 22 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Drug: Bupivacaine + dexamethasone · Device: Ultrasound
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.
Drug pages: Bupivacaine · Dexamethasone
Anesthetic that will help treat pain and sensation after hip arthroscopy
Ultrasound will help guide the anesthesiologist in performing the nerve block
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours after Post Anesthesia Care Unite (PACU) arrival
Opioid Use
Amount of opioids taken after surgery
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
Scale of 0-10; 0 being extremely dissatisfied and 10 being extremely satisfied
Time frame: 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.
Time frame: 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
Time frame: Up to Post Op Day 1
Urinary Retention
Incidence of Urinary Retention in recovery
Time frame: Up to Post Op Day 1
Incidence of Hypotension
Time frame: Up to Post Op Day 1
| Milestone | QLB Block + Standard of Care | Standard of Care |
|---|---|---|
| Started | 48 | 48 |
| Completed | 48 | 48 |
| Not completed | 0 | 0 |
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.
| score on a scale | QLB Block + Standard of Care | Standard of Care |
|---|---|---|
| NRS at Rest | 3.3 ± 3.4 | 4.4 ± 3.3 |
| NRS with Movement | 4.5 ± 4 | 4.7 ± 3.6 |
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.
| score on a scale | QLB Block + Standard of Care | Standard of Care |
|---|---|---|
| NRS at Rest | 3.7 ± 3.2 | 4.6 ± 3.7 |
| NRS with Movement | 4.1 ± 3.2 | 5.2 ± 2.9 |
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.
| score on a scale | QLB Block + Standard of Care | Standard of Care |
|---|---|---|
| NRS at Rest | 4.1 ± 2.1 | 4.6 ± 2.4 |
| NRS with Movement | 4.5 ± 2.3 | 4.8 ± 2.5 |
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.
| score on a scale | QLB Block + Standard of Care | Standard of Care |
|---|---|---|
| NRS at Rest | 4.1 ± 2.3 | 4.6 ± 2.2 |
| NRS with Movement | 4.6 ± 2.3 | 4.8 ± 2.4 |
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.
| score on a scale | QLB Block + Standard of Care | Standard of Care |
|---|---|---|
| NRS at Rest | 3.3 ± 2.5 | 3.8 ± 2.1 |
| NRS with Movement | 5.7 ± 2.6 | 5.7 ± 2.3 |
Amount of opioids taken after surgery
| oral morphine equivalent units (mg) | QLB Block + Standard of Care | Standard of Care |
|---|---|---|
| Opioid Use | 75 (41 to 90) | 68 (45 to 75) |
| Participants | QLB Block + Standard of Care | Standard of Care |
|---|---|---|
| Number of Patients With Presence of IAFE (Intraabdominal Fluid Extravasation) Following Surgery | 9 | 11 |
| Participants | QLB Block + Standard of Care | Standard of Care |
|---|---|---|
| Nausea PACU | 12 | 7 |
| Nausea POD1 (24hr) | 21 | 19 |
| Vomiting PACU | 0 | 1 |
| Vomiting POD1 (24hr) | 2 | 3 |
| Participants | QLB Block + Standard of Care | Standard of Care |
|---|---|---|
| Antiemetic Use | 18 | 12 |
| Participants | QLB Block + Standard of Care | Standard of Care |
|---|---|---|
| Number of Participants With Hospital Admission | 11 | 9 |
Scale of 0-10; 0 being extremely dissatisfied and 10 being extremely satisfied
| score on a scale | QLB Block + Standard of Care | Standard of Care |
|---|---|---|
| PACU | 8 ± 2 | 9 ± 2 |
| POD1 | 8 ± 2 | 9 ± 2 |
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.
| score on a scale | QLB Block + Standard of Care | Standard of Care |
|---|---|---|
| PACU | 104.9 ± 7 | 107.5 ± 7.1 |
| POD1 | 105.6 ± 7.4 | 105 ± 7.3 |
Change in Quadriceps Motor Strength from Pre-Op Baseline Quadriceps Strength
| kg | QLB Block + Standard of Care | Standard of Care |
|---|---|---|
| Change in Quadriceps Motor Strength on Surgical Side | -4.4 ± 3.3 | -3.5 ± 2.4 |
Incidence of Urinary Retention in recovery
| Participants | QLB Block + Standard of Care | Standard of Care |
|---|---|---|
| Urinary Retention | 1 | 0 |
| Participants | QLB Block + Standard of Care | Standard of Care |
|---|---|---|
| Incidence of Hypotension | 16 | 19 |
Collected over 6 months following surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| QLB Block + Standard of Care | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) |
| Standard of Care | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) |
| Age, Continuous(years) | QLB Block + Standard of Care | Standard of Care | Total |
|---|---|---|---|
| Mean | 36 ± 13 | 36 ± 12 | 36 ± 13 |
| Sex: Female, Male(Participants) | QLB Block + Standard of Care | Standard of Care | Total |
|---|---|---|---|
| Female | 26 | 24 | 50 |
| Male | 22 | 24 | 46 |
| Race and Ethnicity Not Collected(Participants) | QLB Block + Standard of Care | Standard of Care | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| BMI (Body Mass Index)(kg/m^2) | QLB Block + Standard of Care | Standard of Care | Total |
|---|---|---|---|
| Mean | 26 ± 5.7 | 24.9 ± 3.8 | 25 ± 4.9 |
| Short Form-8 Health Questionnaire(units on a scale) | QLB Block + Standard of Care | Standard of Care | Total |
|---|---|---|---|
| Mean | 16 ± 4 | 17 ± 6 | 16.4 ± 5.2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Bupivacaine · Dexamethasone
Hospital for Special Surgery, New York →