Trial Outcomes & Findings for Evaluation of Anterior Quadratus Lumborum Block for Postoperative Analgesia in Hip Arthroscopy (NCT NCT03432650)
NCT ID: NCT03432650
Last Updated: 2022-08-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
96 participants
Primary outcome timeframe
30min after Post Anesthesia Care Unite (PACU) arrival
Results posted on
2022-08-19
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
48
|
|
Overall Study
COMPLETED
|
48
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
QLB Block + Standard of Care
n=48 Participants
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
|
Standard of Care
n=48 Participants
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.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 13 • n=48 Participants
|
36 years
STANDARD_DEVIATION 12 • n=48 Participants
|
36 years
STANDARD_DEVIATION 13 • n=96 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=48 Participants
|
24 Participants
n=48 Participants
|
50 Participants
n=96 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=48 Participants
|
24 Participants
n=48 Participants
|
46 Participants
n=96 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI (Body Mass Index)
|
26 kg/m^2
STANDARD_DEVIATION 5.7 • n=48 Participants
|
24.9 kg/m^2
STANDARD_DEVIATION 3.8 • n=48 Participants
|
25 kg/m^2
STANDARD_DEVIATION 4.9 • n=96 Participants
|
|
Short Form-8 Health Questionnaire
|
16 units on a scale
STANDARD_DEVIATION 4 • n=48 Participants
|
17 units on a scale
STANDARD_DEVIATION 6 • n=48 Participants
|
16.4 units on a scale
STANDARD_DEVIATION 5.2 • n=96 Participants
|
PRIMARY outcome
Timeframe: 30min after Post Anesthesia Care Unite (PACU) arrivalPain 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.
Outcome measures
| Measure |
QLB Block + Standard of Care
n=48 Participants
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
|
Standard of Care
n=48 Participants
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.
|
|---|---|---|
|
Numerical Pain Rating System (NRS) Pain Scores
NRS at Rest
|
3.3 score on a scale
Standard Deviation 3.4
|
4.4 score on a scale
Standard Deviation 3.3
|
|
Numerical Pain Rating System (NRS) Pain Scores
NRS with Movement
|
4.5 score on a scale
Standard Deviation 4
|
4.7 score on a scale
Standard Deviation 3.6
|
PRIMARY outcome
Timeframe: 1 hour after Post Anesthesia Care Unite (PACU) arrivalPain 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.
Outcome measures
| Measure |
QLB Block + Standard of Care
n=48 Participants
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
|
Standard of Care
n=48 Participants
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.
|
|---|---|---|
|
Numerical Pain Rating System (NRS) Pain Scores
NRS at Rest
|
3.7 score on a scale
Standard Deviation 3.2
|
4.6 score on a scale
Standard Deviation 3.7
|
|
Numerical Pain Rating System (NRS) Pain Scores
NRS with Movement
|
4.1 score on a scale
Standard Deviation 3.2
|
5.2 score on a scale
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: 2 hours after Post Anesthesia Care Unite (PACU) arrivalPain 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.
Outcome measures
| Measure |
QLB Block + Standard of Care
n=48 Participants
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
|
Standard of Care
n=48 Participants
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.
|
|---|---|---|
|
Numerical Pain Rating System (NRS) Pain Scores
NRS at Rest
|
4.1 score on a scale
Standard Deviation 2.1
|
4.6 score on a scale
Standard Deviation 2.4
|
|
Numerical Pain Rating System (NRS) Pain Scores
NRS with Movement
|
4.5 score on a scale
Standard Deviation 2.3
|
4.8 score on a scale
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: 3 hours after Post Anesthesia Care Unite (PACU) arrivalPain 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.
Outcome measures
| Measure |
QLB Block + Standard of Care
n=48 Participants
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
|
Standard of Care
n=48 Participants
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.
|
|---|---|---|
|
Numerical Pain Rating System (NRS) Pain Scores
NRS at Rest
|
4.1 score on a scale
Standard Deviation 2.3
|
4.6 score on a scale
Standard Deviation 2.2
|
|
Numerical Pain Rating System (NRS) Pain Scores
NRS with Movement
|
4.6 score on a scale
Standard Deviation 2.3
|
4.8 score on a scale
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: 24 hours after Post Anesthesia Care Unite (PACU) arrivalPain 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.
Outcome measures
| Measure |
QLB Block + Standard of Care
n=48 Participants
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
|
Standard of Care
n=48 Participants
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.
|
|---|---|---|
|
Numerical Pain Rating System (NRS) Pain Scores
NRS at Rest
|
3.3 score on a scale
Standard Deviation 2.5
|
3.8 score on a scale
Standard Deviation 2.1
|
|
Numerical Pain Rating System (NRS) Pain Scores
NRS with Movement
|
5.7 score on a scale
Standard Deviation 2.6
|
5.7 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: After Surgery to Post Operative Day 1Amount of opioids taken after surgery
Outcome measures
| Measure |
QLB Block + Standard of Care
n=48 Participants
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
|
Standard of Care
n=48 Participants
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.
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|---|---|---|
|
Opioid Use
|
75 oral morphine equivalent units (mg)
Interval 41.0 to 90.0
|
68 oral morphine equivalent units (mg)
Interval 45.0 to 75.0
|
SECONDARY outcome
Timeframe: Immediately post-op in OROutcome measures
| Measure |
QLB Block + Standard of Care
n=48 Participants
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
|
Standard of Care
n=48 Participants
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.
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|---|---|---|
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Number of Patients With Presence of IAFE (Intraabdominal Fluid Extravasation) Following Surgery
|
9 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to Post Op Day 1Population: some patients did not answer survey questions
Outcome measures
| Measure |
QLB Block + Standard of Care
n=48 Participants
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
|
Standard of Care
n=48 Participants
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.
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|---|---|---|
|
Number of Patients With Nausea/Vomiting
Nausea PACU
|
12 Participants
|
7 Participants
|
|
Number of Patients With Nausea/Vomiting
Nausea POD1 (24hr)
|
21 Participants
|
19 Participants
|
|
Number of Patients With Nausea/Vomiting
Vomiting PACU
|
0 Participants
|
1 Participants
|
|
Number of Patients With Nausea/Vomiting
Vomiting POD1 (24hr)
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to Post Op Day 1Outcome measures
| Measure |
QLB Block + Standard of Care
n=48 Participants
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
|
Standard of Care
n=48 Participants
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.
|
|---|---|---|
|
Antiemetic Use
|
18 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Up to Post Op Day 1Outcome measures
| Measure |
QLB Block + Standard of Care
n=48 Participants
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
|
Standard of Care
n=48 Participants
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.
|
|---|---|---|
|
Number of Participants With Hospital Admission
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to Post Op Day 1Population: some patients did not answer questionnaire.
Scale of 0-10; 0 being extremely dissatisfied and 10 being extremely satisfied
Outcome measures
| Measure |
QLB Block + Standard of Care
n=48 Participants
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
|
Standard of Care
n=48 Participants
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.
|
|---|---|---|
|
Patient Satisfaction With Post Op Pain Control
PACU
|
8 score on a scale
Standard Deviation 2
|
9 score on a scale
Standard Deviation 2
|
|
Patient Satisfaction With Post Op Pain Control
POD1
|
8 score on a scale
Standard Deviation 2
|
9 score on a scale
Standard Deviation 2
|
SECONDARY outcome
Timeframe: Up to Post Op Day 1Population: Some patients did not answer questionnaire
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.
Outcome measures
| Measure |
QLB Block + Standard of Care
n=46 Participants
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
|
Standard of Care
n=46 Participants
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.
|
|---|---|---|
|
Patient Score on Quality of Recovery-40 (QoR40) Inventory.
PACU
|
104.9 score on a scale
Standard Deviation 7
|
107.5 score on a scale
Standard Deviation 7.1
|
|
Patient Score on Quality of Recovery-40 (QoR40) Inventory.
POD1
|
105.6 score on a scale
Standard Deviation 7.4
|
105 score on a scale
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Up to Post Op Day 1Population: some patients were lost to follow up
Change in Quadriceps Motor Strength from Pre-Op Baseline Quadriceps Strength
Outcome measures
| Measure |
QLB Block + Standard of Care
n=27 Participants
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
|
Standard of Care
n=30 Participants
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.
|
|---|---|---|
|
Change in Quadriceps Motor Strength on Surgical Side
|
-4.4 kg
Standard Deviation 3.3
|
-3.5 kg
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Up to Post Op Day 1Incidence of Urinary Retention in recovery
Outcome measures
| Measure |
QLB Block + Standard of Care
n=48 Participants
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
|
Standard of Care
n=48 Participants
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.
|
|---|---|---|
|
Urinary Retention
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Post Op Day 1Outcome measures
| Measure |
QLB Block + Standard of Care
n=48 Participants
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
|
Standard of Care
n=48 Participants
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.
|
|---|---|---|
|
Incidence of Hypotension
|
16 Participants
|
19 Participants
|
Adverse Events
QLB Block + Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Stephen Haskins
Hospital for Special Surgery, Anesthesiology
Phone: 212-606-1036
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place