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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine + dexamethasone | Drug | Anesthetic that will help treat pain and sensation after hip arthroscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 24 hours after Post Anesthesia Care Unite (PACU) arrival |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use | Amount of opioids taken after surgery | After Surgery to Post Operative Day 1 |
| Number of Patients With Presence of IAFE (Intraabdominal Fluid Extravasation) Following Surgery | Immediately post-op in OR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Haskins, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | QLB Block + Standard of Care | 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). Bupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy Ultrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block |
| FG001 | Standard of Care | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | QLB Block + Standard of Care | 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). Bupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy Ultrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 30min after Post Anesthesia Care Unite (PACU) arrival |
|
6 months following surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | QLB Block + Standard of Care | 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). Bupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy Ultrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephen Haskins | Hospital for Special Surgery, Anesthesiology | 212-606-1036 | haskinss@hss.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2019 | Apr 8, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D003907 | Dexamethasone |
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ultrasound | Device | Ultrasound will help guide the anesthesiologist in performing the nerve block |
|
| Number of Patients With Nausea/Vomiting | Up to Post Op Day 1 |
| Antiemetic Use | Up to Post Op Day 1 |
| Number of Participants With Hospital Admission | 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 | 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. | 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 | Up to Post Op Day 1 |
| Urinary Retention | Incidence of Urinary Retention in recovery | Up to Post Op Day 1 |
| Incidence of Hypotension | Up to Post Op Day 1 |
| BG001 | Standard of Care | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI (Body Mass Index) | Mean | Standard Deviation | kg/m^2 |
|
| Short Form-8 Health Questionnaire | This questionnaire consists of 8 questions. The score for each question is 1-5. a lower score is a better outcome. maximum score is 40, minimum score is 8. scores are reported the total for all 8 questions combined. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Standard of Care | 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. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 hour after Post Anesthesia Care Unite (PACU) arrival |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 hours after Post Anesthesia Care Unite (PACU) arrival |
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|
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 hours after Post Anesthesia Care Unite (PACU) arrival |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 24 hours after Post Anesthesia Care Unite (PACU) arrival |
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| Secondary | Opioid Use | Amount of opioids taken after surgery | Posted | Median | Inter-Quartile Range | oral morphine equivalent units (mg) | After Surgery to Post Operative Day 1 |
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| Secondary | Number of Patients With Presence of IAFE (Intraabdominal Fluid Extravasation) Following Surgery | Posted | Count of Participants | Participants | Immediately post-op in OR |
|
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| Secondary | Number of Patients With Nausea/Vomiting | some patients did not answer survey questions | Posted | Count of Participants | Participants | Up to Post Op Day 1 |
|
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| Secondary | Antiemetic Use | Posted | Count of Participants | Participants | Up to Post Op Day 1 |
|
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| Secondary | Number of Participants With Hospital Admission | Posted | Count of Participants | Participants | Up to Post Op Day 1 |
|
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| Secondary | Patient Satisfaction With Post Op Pain Control | Scale of 0-10; 0 being extremely dissatisfied and 10 being extremely satisfied | some patients did not answer questionnaire. | Posted | Mean | Standard Deviation | score on a scale | Up to Post Op Day 1 |
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| Secondary | 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. | Some patients did not answer questionnaire | Posted | Mean | Standard Deviation | score on a scale | Up to Post Op Day 1 |
|
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| Secondary | Change in Quadriceps Motor Strength on Surgical Side | Change in Quadriceps Motor Strength from Pre-Op Baseline Quadriceps Strength | some patients were lost to follow up | Posted | Mean | Standard Deviation | kg | Up to Post Op Day 1 |
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| Secondary | Urinary Retention | Incidence of Urinary Retention in recovery | Posted | Count of Participants | Participants | Up to Post Op Day 1 |
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| Secondary | Incidence of Hypotension | Posted | Count of Participants | Participants | Up to Post Op Day 1 |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Standard of Care | 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. | 0 | 48 | 0 | 48 | 0 | 48 |
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| D000588 |
| Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| Nausea POD1 (24hr) |
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| Vomiting PACU |
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| Vomiting POD1 (24hr) |
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| POD1 |
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| POD1 |
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