Hip Disease
Conditions
Brief 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. 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.
Interventions
Anesthetic that will help treat pain and sensation after hip arthroscopy
DEVICEUltrasound
Ultrasound will help guide the anesthesiologist in performing the nerve block
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for hip arthroscopy * Ability to follow study protocol * English Speaking
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Pain Rating System (NRS) Pain Scores | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Presence of IAFE (Intraabdominal Fluid Extravasation) Following Surgery | Immediately post-op in OR | — |
| 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 | — |
| Opioid Use | After Surgery to Post Operative Day 1 | Amount of opioids taken after surgery |
| Patient Score on Quality of Recovery-40 (QoR40) Inventory. | Up to Post Op Day 1 | 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. |
| Change in Quadriceps Motor Strength on Surgical Side | Up to Post Op Day 1 | Change in Quadriceps Motor Strength from Pre-Op Baseline Quadriceps Strength |
| Urinary Retention | Up to Post Op Day 1 | Incidence of Urinary Retention in recovery |
| Incidence of Hypotension | Up to Post Op Day 1 | — |
| Patient Satisfaction With Post Op Pain Control | Up to Post Op Day 1 | Scale of 0-10; 0 being extremely dissatisfied and 10 being extremely satisfied |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 48 |
| 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. | 48 |
| Total | 96 |
Baseline characteristics
| Characteristic | Standard of Care | QLB Block + Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 36 years STANDARD_DEVIATION 12 | 36 years STANDARD_DEVIATION 13 | 36 years STANDARD_DEVIATION 13 |
| BMI (Body Mass Index) | 24.9 kg/m^2 STANDARD_DEVIATION 3.8 | 26 kg/m^2 STANDARD_DEVIATION 5.7 | 25 kg/m^2 STANDARD_DEVIATION 4.9 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 24 Participants | 26 Participants | 50 Participants |
| Sex: Female, Male Male | 24 Participants | 22 Participants | 46 Participants |
| Short Form-8 Health Questionnaire | 17 units on a scale STANDARD_DEVIATION 6 | 16 units on a scale STANDARD_DEVIATION 4 | 16.4 units on a scale STANDARD_DEVIATION 5.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 48 |
| other Total, other adverse events | 0 / 48 | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 |
Outcome results
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.
Time frame: 2 hours after Post Anesthesia Care Unite (PACU) arrival
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| QLB Block + Standard of Care | Numerical Pain Rating System (NRS) Pain Scores | NRS at Rest | 4.1 score on a scale | Standard Deviation 2.1 |
| QLB Block + Standard of Care | Numerical Pain Rating System (NRS) Pain Scores | NRS with Movement | 4.5 score on a scale | Standard Deviation 2.3 |
| Standard of Care | Numerical Pain Rating System (NRS) Pain Scores | NRS at Rest | 4.6 score on a scale | Standard Deviation 2.4 |
| Standard of Care | Numerical Pain Rating System (NRS) Pain Scores | NRS with Movement | 4.8 score on a scale | Standard Deviation 2.5 |
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.
Time frame: 24 hours after Post Anesthesia Care Unite (PACU) arrival
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| QLB Block + Standard of Care | Numerical Pain Rating System (NRS) Pain Scores | NRS at Rest | 3.3 score on a scale | Standard Deviation 2.5 |
| QLB Block + Standard of Care | Numerical Pain Rating System (NRS) Pain Scores | NRS with Movement | 5.7 score on a scale | Standard Deviation 2.6 |
| Standard of Care | Numerical Pain Rating System (NRS) Pain Scores | NRS at Rest | 3.8 score on a scale | Standard Deviation 2.1 |
| Standard of Care | Numerical Pain Rating System (NRS) Pain Scores | NRS with Movement | 5.7 score on a scale | Standard Deviation 2.3 |
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.
Time frame: 3 hours after Post Anesthesia Care Unite (PACU) arrival
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| QLB Block + Standard of Care | Numerical Pain Rating System (NRS) Pain Scores | NRS at Rest | 4.1 score on a scale | Standard Deviation 2.3 |
| QLB Block + Standard of Care | Numerical Pain Rating System (NRS) Pain Scores | NRS with Movement | 4.6 score on a scale | Standard Deviation 2.3 |
| Standard of Care | Numerical Pain Rating System (NRS) Pain Scores | NRS at Rest | 4.6 score on a scale | Standard Deviation 2.2 |
| Standard of Care | Numerical Pain Rating System (NRS) Pain Scores | NRS with Movement | 4.8 score on a scale | Standard Deviation 2.4 |
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.
Time frame: 30min after Post Anesthesia Care Unite (PACU) arrival
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| QLB Block + Standard of Care | Numerical Pain Rating System (NRS) Pain Scores | NRS at Rest | 3.3 score on a scale | Standard Deviation 3.4 |
| QLB Block + Standard of Care | Numerical Pain Rating System (NRS) Pain Scores | NRS with Movement | 4.5 score on a scale | Standard Deviation 4 |
| Standard of Care | Numerical Pain Rating System (NRS) Pain Scores | NRS at Rest | 4.4 score on a scale | Standard Deviation 3.3 |
| Standard of Care | Numerical Pain Rating System (NRS) Pain Scores | NRS with Movement | 4.7 score on a scale | Standard Deviation 3.6 |
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.
Time frame: 1 hour after Post Anesthesia Care Unite (PACU) arrival
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| QLB Block + Standard of Care | Numerical Pain Rating System (NRS) Pain Scores | NRS at Rest | 3.7 score on a scale | Standard Deviation 3.2 |
| QLB Block + Standard of Care | Numerical Pain Rating System (NRS) Pain Scores | NRS with Movement | 4.1 score on a scale | Standard Deviation 3.2 |
| Standard of Care | Numerical Pain Rating System (NRS) Pain Scores | NRS at Rest | 4.6 score on a scale | Standard Deviation 3.7 |
| Standard of Care | Numerical Pain Rating System (NRS) Pain Scores | NRS with Movement | 5.2 score on a scale | Standard Deviation 2.9 |
Secondary
Antiemetic Use
Time frame: Up to Post Op Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QLB Block + Standard of Care | Antiemetic Use | 18 Participants |
| Standard of Care | Antiemetic Use | 12 Participants |
Secondary
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
Population: some patients were lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QLB Block + Standard of Care | Change in Quadriceps Motor Strength on Surgical Side | -4.4 kg | Standard Deviation 3.3 |
| Standard of Care | Change in Quadriceps Motor Strength on Surgical Side | -3.5 kg | Standard Deviation 2.4 |
Secondary
Incidence of Hypotension
Time frame: Up to Post Op Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QLB Block + Standard of Care | Incidence of Hypotension | 16 Participants |
| Standard of Care | Incidence of Hypotension | 19 Participants |
Secondary
Number of Participants With Hospital Admission
Time frame: Up to Post Op Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QLB Block + Standard of Care | Number of Participants With Hospital Admission | 11 Participants |
| Standard of Care | Number of Participants With Hospital Admission | 9 Participants |
Secondary
Number of Patients With Nausea/Vomiting
Time frame: Up to Post Op Day 1
Population: some patients did not answer survey questions
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| QLB Block + Standard of Care | Number of Patients With Nausea/Vomiting | Nausea PACU | 12 Participants |
| QLB Block + Standard of Care | Number of Patients With Nausea/Vomiting | Nausea POD1 (24hr) | 21 Participants |
| QLB Block + Standard of Care | Number of Patients With Nausea/Vomiting | Vomiting PACU | 0 Participants |
| QLB Block + Standard of Care | Number of Patients With Nausea/Vomiting | Vomiting POD1 (24hr) | 2 Participants |
| Standard of Care | Number of Patients With Nausea/Vomiting | Vomiting POD1 (24hr) | 3 Participants |
| Standard of Care | Number of Patients With Nausea/Vomiting | Nausea PACU | 7 Participants |
| Standard of Care | Number of Patients With Nausea/Vomiting | Vomiting PACU | 1 Participants |
| Standard of Care | Number of Patients With Nausea/Vomiting | Nausea POD1 (24hr) | 19 Participants |
Secondary
Number of Patients With Presence of IAFE (Intraabdominal Fluid Extravasation) Following Surgery
Time frame: Immediately post-op in OR
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QLB Block + Standard of Care | Number of Patients With Presence of IAFE (Intraabdominal Fluid Extravasation) Following Surgery | 9 Participants |
| Standard of Care | Number of Patients With Presence of IAFE (Intraabdominal Fluid Extravasation) Following Surgery | 11 Participants |
Secondary
Opioid Use
Amount of opioids taken after surgery
Time frame: After Surgery to Post Operative Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| QLB Block + Standard of Care | Opioid Use | 75 oral morphine equivalent units (mg) |
| Standard of Care | Opioid Use | 68 oral morphine equivalent units (mg) |
Secondary
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
Population: some patients did not answer questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| QLB Block + Standard of Care | Patient Satisfaction With Post Op Pain Control | PACU | 8 score on a scale | Standard Deviation 2 |
| QLB Block + Standard of Care | Patient Satisfaction With Post Op Pain Control | POD1 | 8 score on a scale | Standard Deviation 2 |
| Standard of Care | Patient Satisfaction With Post Op Pain Control | PACU | 9 score on a scale | Standard Deviation 2 |
| Standard of Care | Patient Satisfaction With Post Op Pain Control | POD1 | 9 score on a scale | Standard Deviation 2 |
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.
Time frame: Up to Post Op Day 1
Population: Some patients did not answer questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| QLB Block + Standard of Care | Patient Score on Quality of Recovery-40 (QoR40) Inventory. | PACU | 104.9 score on a scale | Standard Deviation 7 |
| QLB Block + Standard of Care | Patient Score on Quality of Recovery-40 (QoR40) Inventory. | POD1 | 105.6 score on a scale | Standard Deviation 7.4 |
| Standard of Care | Patient Score on Quality of Recovery-40 (QoR40) Inventory. | PACU | 107.5 score on a scale | Standard Deviation 7.1 |
| Standard of Care | Patient Score on Quality of Recovery-40 (QoR40) Inventory. | POD1 | 105 score on a scale | Standard Deviation 7.3 |
Secondary
Urinary Retention
Incidence of Urinary Retention in recovery
Time frame: Up to Post Op Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QLB Block + Standard of Care | Urinary Retention | 1 Participants |
| Standard of Care | Urinary Retention | 0 Participants |