Trial Outcomes & Findings for Quadratus Lumborum Block for Analgesia Following Hip Arthroscopy (NCT NCT03557125)
NCT ID: NCT03557125
Last Updated: 2021-02-02
Results Overview
opioid consumption including intraoperative consumption exceeding 100µg of fentanyl and all postoperative opioid consumption in the postoperative anesthesia care unit (PACU).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
24 hours
Results posted on
2021-02-02
Participant Flow
Participant milestones
| Measure |
Receives QL Block
If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
QL Block: If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
|
Receives Saline Skin Wheel No Block
The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.
Saline Skin Wheel: The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
24
|
|
Overall Study
COMPLETED
|
22
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Quadratus Lumborum Block for Analgesia Following Hip Arthroscopy
Baseline characteristics by cohort
| Measure |
Receives QL Block
n=22 Participants
If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
QL Block: If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
|
Receives Saline Skin Wheel No Block
n=24 Participants
The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.
Saline Skin Wheel: The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29.8 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
37.1 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
33.6 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
24 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
26.2 kg/m2
STANDARD_DEVIATION 4.3 • n=5 Participants
|
27.4 kg/m2
STANDARD_DEVIATION 5.5 • n=7 Participants
|
26.8 kg/m2
STANDARD_DEVIATION 5.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursopioid consumption including intraoperative consumption exceeding 100µg of fentanyl and all postoperative opioid consumption in the postoperative anesthesia care unit (PACU).
Outcome measures
| Measure |
Receives QL Block
n=22 Participants
If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
QL Block: If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
|
Receives Saline Skin Wheel No Block
n=24 Participants
The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.
Saline Skin Wheel: The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.
|
|---|---|---|
|
Opioid Consumption
|
8.1 Morphine Milligram Equivalents
Interval 6.0 to 10.2
|
11.3 Morphine Milligram Equivalents
Interval 9.0 to 13.6
|
SECONDARY outcome
Timeframe: Immediately Post Operativelyvisual analog pain scaled on PACU arrival. The visual analog scale is measured 0-100. Zero being no pain at all and 100 being the worse pain the participant has ever experienced.
Outcome measures
| Measure |
Receives QL Block
n=22 Participants
If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
QL Block: If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
|
Receives Saline Skin Wheel No Block
n=24 Participants
The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.
Saline Skin Wheel: The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.
|
|---|---|---|
|
Visual Analog Pain
|
58.6 millimeters
Standard Deviation 27.1
|
59.6 millimeters
Standard Deviation 31.5
|
SECONDARY outcome
Timeframe: 2 hoursThe visual analog scale is measured 0-100. Zero being no pain at all and 100 being the worse pain the participant has ever experienced.
Outcome measures
| Measure |
Receives QL Block
n=22 Participants
If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
QL Block: If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
|
Receives Saline Skin Wheel No Block
n=24 Participants
The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.
Saline Skin Wheel: The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.
|
|---|---|---|
|
Visual Analog Scale at Time of Post Anesthesia Care Unit Discharge
|
57.9 millimeters
Standard Deviation 22.2
|
59.2 millimeters
Standard Deviation 22.6
|
SECONDARY outcome
Timeframe: 2 hoursOutcome measures
| Measure |
Receives QL Block
n=22 Participants
If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
QL Block: If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
|
Receives Saline Skin Wheel No Block
n=24 Participants
The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.
Saline Skin Wheel: The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.
|
|---|---|---|
|
Post Anesthesia Care Unit Duration
|
99.9 minutes
Standard Deviation 27.9
|
110.3 minutes
Standard Deviation 34.0
|
SECONDARY outcome
Timeframe: 24 hoursThe scale is measure 0-10. Zero being not satisfied with pain control at all and 10 being totally satisfied with pain control.
Outcome measures
| Measure |
Receives QL Block
n=22 Participants
If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
QL Block: If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
|
Receives Saline Skin Wheel No Block
n=24 Participants
The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.
Saline Skin Wheel: The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.
|
|---|---|---|
|
Patient Satisfaction
|
7.5 units on a scale
Standard Deviation 3.5
|
8.6 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
Receives QL Block
n=22 Participants
If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
QL Block: If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
|
Receives Saline Skin Wheel No Block
n=24 Participants
The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.
Saline Skin Wheel: The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.
|
|---|---|---|
|
Opioid Related Side Effects
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
Receives QL Block
n=7 Participants
If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
QL Block: If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
|
Receives Saline Skin Wheel No Block
n=1 Participants
The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.
Saline Skin Wheel: The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.
|
|---|---|---|
|
Duration of Nerve Block
|
955.7 minutes
Standard Deviation 298.4
|
105 minutes
Standard Deviation NA
only one participant was evaluated
|
Adverse Events
Receives QL Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Receives Saline Skin Wheel No Block
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place