Evaluation of Anterior Quadratus Lumborum Block for Postoperative Analgesia in Hip Arthroscopy

Sponsor
Hospital for Special Surgery, New York (Other)
Overall Status
Completed
CT.gov ID
NCT03432650
Collaborator
(none)
96
1
2
39.3
2.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bupivacaine + dexamethasone
  • Device: Ultrasound
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of Anterior Quadratus Lumborum Block for Postoperative Analgesia in Hip Arthroscopy: A Double-Blinded Randomized Controlled Trial
Actual Study Start Date :
Jun 1, 2018
Actual Primary Completion Date :
Dec 20, 2020
Actual Study Completion Date :
Sep 9, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

Drug: Bupivacaine + dexamethasone
Anesthetic that will help treat pain and sensation after hip arthroscopy

Device: Ultrasound
Ultrasound will help guide the anesthesiologist in performing the nerve block

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. Numerical Pain Rating System (NRS) Pain Scores [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.

  3. Numerical Pain Rating System (NRS) Pain Scores [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.

  4. Numerical Pain Rating System (NRS) Pain Scores [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.

  5. Numerical Pain Rating System (NRS) Pain Scores [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.

Secondary Outcome Measures

  1. Opioid Use [After Surgery to Post Operative Day 1]

    Amount of opioids taken after surgery

  2. Number of Patients With Presence of IAFE (Intraabdominal Fluid Extravasation) Following Surgery [Immediately post-op in OR]

  3. Number of Patients With Nausea/Vomiting [Up to Post Op Day 1]

  4. Antiemetic Use [Up to Post Op Day 1]

  5. Number of Participants With Hospital Admission [Up to Post Op Day 1]

  6. 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

  7. 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.

  8. 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

  9. Urinary Retention [Up to Post Op Day 1]

    Incidence of Urinary Retention in recovery

  10. Incidence of Hypotension [Up to Post Op Day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital of Special Surgery New York New York United States 10021

Sponsors and Collaborators

  • Hospital for Special Surgery, New York

Investigators

  • Principal Investigator: Stephen Haskins, MD, Hospital for Special Surgery, New York

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT03432650
Other Study ID Numbers:
  • 2018-0647
First Posted:
Feb 14, 2018
Last Update Posted:
Aug 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title QLB Block + Standard of Care Standard of Care
Arm/Group Description 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 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.
Period Title: Overall Study
STARTED 48 48
COMPLETED 48 48
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title QLB Block + Standard of Care Standard of Care Total
Arm/Group Description 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 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 of all reporting groups
Overall Participants 48 48 96
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
36
(13)
36
(12)
36
(13)
Sex: Female, Male (Count of Participants)
Female
26
54.2%
24
50%
50
52.1%
Male
22
45.8%
24
50%
46
47.9%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%
BMI (Body Mass Index) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]
26
(5.7)
24.9
(3.8)
25
(4.9)
Short Form-8 Health Questionnaire (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
16
(4)
17
(6)
16.4
(5.2)

Outcome Measures

1. Primary Outcome
Title Numerical Pain Rating System (NRS) Pain Scores
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title QLB Block + Standard of Care Standard of Care
Arm/Group Description 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 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.
Measure Participants 48 48
NRS at Rest
3.3
(3.4)
4.4
(3.3)
NRS with Movement
4.5
(4)
4.7
(3.6)
2. Primary Outcome
Title Numerical Pain Rating System (NRS) Pain Scores
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title QLB Block + Standard of Care Standard of Care
Arm/Group Description 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 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.
Measure Participants 48 48
NRS at Rest
3.7
(3.2)
4.6
(3.7)
NRS with Movement
4.1
(3.2)
5.2
(2.9)
3. Primary Outcome
Title Numerical Pain Rating System (NRS) Pain Scores
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title QLB Block + Standard of Care Standard of Care
Arm/Group Description 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 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.
Measure Participants 48 48
NRS at Rest
4.1
(2.1)
4.6
(2.4)
NRS with Movement
4.5
(2.3)
4.8
(2.5)
4. Primary Outcome
Title Numerical Pain Rating System (NRS) Pain Scores
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title QLB Block + Standard of Care Standard of Care
Arm/Group Description 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 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.
Measure Participants 48 48
NRS at Rest
4.1
(2.3)
4.6
(2.2)
NRS with Movement
4.6
(2.3)
4.8
(2.4)
5. Primary Outcome
Title Numerical Pain Rating System (NRS) Pain Scores
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title QLB Block + Standard of Care Standard of Care
Arm/Group Description 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 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.
Measure Participants 48 48
NRS at Rest
3.3
(2.5)
3.8
(2.1)
NRS with Movement
5.7
(2.6)
5.7
(2.3)
6. Secondary Outcome
Title Opioid Use
Description Amount of opioids taken after surgery
Time Frame After Surgery to Post Operative Day 1

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title QLB Block + Standard of Care Standard of Care
Arm/Group Description 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 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.
Measure Participants 48 48
Median (Inter-Quartile Range) [oral morphine equivalent units (mg)]
75
68
7. Secondary Outcome
Title Number of Patients With Presence of IAFE (Intraabdominal Fluid Extravasation) Following Surgery
Description
Time Frame Immediately post-op in OR

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title QLB Block + Standard of Care Standard of Care
Arm/Group Description 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 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.
Measure Participants 48 48
Count of Participants [Participants]
9
18.8%
11
22.9%
8. Secondary Outcome
Title Number of Patients With Nausea/Vomiting
Description
Time Frame Up to Post Op Day 1

Outcome Measure Data

Analysis Population Description
some patients did not answer survey questions
Arm/Group Title QLB Block + Standard of Care Standard of Care
Arm/Group Description 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 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.
Measure Participants 48 48
Nausea PACU
12
25%
7
14.6%
Nausea POD1 (24hr)
21
43.8%
19
39.6%
Vomiting PACU
0
0%
1
2.1%
Vomiting POD1 (24hr)
2
4.2%
3
6.3%
9. Secondary Outcome
Title Antiemetic Use
Description
Time Frame Up to Post Op Day 1

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title QLB Block + Standard of Care Standard of Care
Arm/Group Description 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 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.
Measure Participants 48 48
Count of Participants [Participants]
18
37.5%
12
25%
10. Secondary Outcome
Title Number of Participants With Hospital Admission
Description
Time Frame Up to Post Op Day 1

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title QLB Block + Standard of Care Standard of Care
Arm/Group Description 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 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.
Measure Participants 48 48
Count of Participants [Participants]
11
22.9%
9
18.8%
11. Secondary Outcome
Title Patient Satisfaction With Post Op Pain Control
Description Scale of 0-10; 0 being extremely dissatisfied and 10 being extremely satisfied
Time Frame Up to Post Op Day 1

Outcome Measure Data

Analysis Population Description
some patients did not answer questionnaire.
Arm/Group Title QLB Block + Standard of Care Standard of Care
Arm/Group Description 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 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.
Measure Participants 48 48
PACU
8
(2)
9
(2)
POD1
8
(2)
9
(2)
12. Secondary Outcome
Title Patient Score on Quality of Recovery-40 (QoR40) Inventory.
Description 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

Outcome Measure Data

Analysis Population Description
Some patients did not answer questionnaire
Arm/Group Title QLB Block + Standard of Care Standard of Care
Arm/Group Description 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 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.
Measure Participants 46 46
PACU
104.9
(7)
107.5
(7.1)
POD1
105.6
(7.4)
105
(7.3)
13. Secondary Outcome
Title Change in Quadriceps Motor Strength on Surgical Side
Description Change in Quadriceps Motor Strength from Pre-Op Baseline Quadriceps Strength
Time Frame Up to Post Op Day 1

Outcome Measure Data

Analysis Population Description
some patients were lost to follow up
Arm/Group Title QLB Block + Standard of Care Standard of Care
Arm/Group Description 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 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.
Measure Participants 27 30
Mean (Standard Deviation) [kg]
-4.4
(3.3)
-3.5
(2.4)
14. Secondary Outcome
Title Urinary Retention
Description Incidence of Urinary Retention in recovery
Time Frame Up to Post Op Day 1

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title QLB Block + Standard of Care Standard of Care
Arm/Group Description 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 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.
Measure Participants 48 48
Count of Participants [Participants]
1
2.1%
0
0%
15. Secondary Outcome
Title Incidence of Hypotension
Description
Time Frame Up to Post Op Day 1

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title QLB Block + Standard of Care Standard of Care
Arm/Group Description 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 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.
Measure Participants 48 48
Count of Participants [Participants]
16
33.3%
19
39.6%

Adverse Events

Time Frame 6 months following surgery
Adverse Event Reporting Description
Arm/Group Title QLB Block + Standard of Care Standard of Care
Arm/Group Description 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 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.
All Cause Mortality
QLB Block + Standard of Care Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/48 (0%) 0/48 (0%)
Serious Adverse Events
QLB Block + Standard of Care Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/48 (0%) 0/48 (0%)
Other (Not Including Serious) Adverse Events
QLB Block + Standard of Care Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/48 (0%) 0/48 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Stephen Haskins
Organization Hospital for Special Surgery, Anesthesiology
Phone 212-606-1036
Email haskinss@hss.edu
Responsible Party:
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT03432650
Other Study ID Numbers:
  • 2018-0647
First Posted:
Feb 14, 2018
Last Update Posted:
Aug 19, 2022
Last Verified:
Jul 1, 2022