Trial Outcomes & Findings for Single Shot Lumbar Erector Spinae Plane (ESP) Block in Total Hip Replacement (THR) (NCT NCT04388553)
NCT ID: NCT04388553
Last Updated: 2024-04-16
Results Overview
at rest
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
First post-operative day
Results posted on
2024-04-16
Participant Flow
Participant milestones
| Measure |
Treatment
lumbar ESP block is performed. Before proceeding to ESP block, the back is cleaned with aseptic technique and draped. 40 mL of 0.25% levobupivacaine (or maximum of 2mg/kg body weight made up to same volume) is injected into the ESP.
single shot lumbar Erector Spinae Plane block: unilateral (operative side), performed at L1 level, under ultrasound guidance
|
Control
no regional anaesthesia is performed nor saline is injected into the ESP
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
35
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Treatment
lumbar ESP block is performed. Before proceeding to ESP block, the back is cleaned with aseptic technique and draped. 40 mL of 0.25% levobupivacaine (or maximum of 2mg/kg body weight made up to same volume) is injected into the ESP.
single shot lumbar Erector Spinae Plane block: unilateral (operative side), performed at L1 level, under ultrasound guidance
|
Control
no regional anaesthesia is performed nor saline is injected into the ESP
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Single Shot Lumbar Erector Spinae Plane (ESP) Block in Total Hip Replacement (THR)
Baseline characteristics by cohort
| Measure |
Treatment
n=35 Participants
lumbar ESP block is performed. Before proceeding to ESP block, the back is cleaned with aseptic technique and draped. 40 mL of 0.25% levobupivacaine (or maximum of 2mg/kg body weight made up to same volume) is injected into the ESP.
single shot lumbar Erector Spinae Plane block: unilateral (operative side), performed at L1 level, under ultrasound guidance
|
Control
n=35 Participants
no regional anaesthesia is performed nor saline is injected into the ESP
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 10.5 • n=99 Participants
|
64.7 years
STANDARD_DEVIATION 10.2 • n=107 Participants
|
64.5 years
STANDARD_DEVIATION 10.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Hong Kong
|
35 participants
n=99 Participants
|
35 participants
n=107 Participants
|
70 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: First post-operative dayat rest
Outcome measures
| Measure |
Treatment
n=35 Participants
lumbar ESP block is performed. Before proceeding to ESP block, the back is cleaned with aseptic technique and draped. 40 mL of 0.25% levobupivacaine (or maximum of 2mg/kg body weight made up to same volume) is injected into the ESP.
single shot lumbar Erector Spinae Plane block: unilateral (operative side), performed at L1 level, under ultrasound guidance
|
Control
n=35 Participants
no regional anaesthesia is performed nor saline is injected into the ESP
|
|---|---|---|
|
Post-operative Pain Score in Numeric Rating Scale (NRS) From 0 (no Pain) to 10 (Extreme Pain)
|
3 score on a scale
Interval 0.0 to 5.0
|
3 score on a scale
Interval 0.0 to 4.5
|
PRIMARY outcome
Timeframe: First post-operative dayupon mobilisation
Outcome measures
| Measure |
Treatment
n=35 Participants
lumbar ESP block is performed. Before proceeding to ESP block, the back is cleaned with aseptic technique and draped. 40 mL of 0.25% levobupivacaine (or maximum of 2mg/kg body weight made up to same volume) is injected into the ESP.
single shot lumbar Erector Spinae Plane block: unilateral (operative side), performed at L1 level, under ultrasound guidance
|
Control
n=35 Participants
no regional anaesthesia is performed nor saline is injected into the ESP
|
|---|---|---|
|
Post-operative Pain Score in Numeric Rating Scale (NRS) From 0 (no Pain) to 10 (Extreme Pain)
|
7 score on a scale
Interval 6.0 to 8.0
|
7 score on a scale
Interval 4.5 to 8.5
|
PRIMARY outcome
Timeframe: 12 hour post-operativelyin microgram
Outcome measures
| Measure |
Treatment
n=35 Participants
lumbar ESP block is performed. Before proceeding to ESP block, the back is cleaned with aseptic technique and draped. 40 mL of 0.25% levobupivacaine (or maximum of 2mg/kg body weight made up to same volume) is injected into the ESP.
single shot lumbar Erector Spinae Plane block: unilateral (operative side), performed at L1 level, under ultrasound guidance
|
Control
n=35 Participants
no regional anaesthesia is performed nor saline is injected into the ESP
|
|---|---|---|
|
Post-operative 12 Hour Fentanyl (Intravenous Patient-controlled Analgesia) Use
|
210 Microgram
Interval 140.5 to 363.0
|
165 Microgram
Interval 77.5 to 330.5
|
PRIMARY outcome
Timeframe: 24 hour post-operativelyin microgram
Outcome measures
| Measure |
Treatment
n=35 Participants
lumbar ESP block is performed. Before proceeding to ESP block, the back is cleaned with aseptic technique and draped. 40 mL of 0.25% levobupivacaine (or maximum of 2mg/kg body weight made up to same volume) is injected into the ESP.
single shot lumbar Erector Spinae Plane block: unilateral (operative side), performed at L1 level, under ultrasound guidance
|
Control
n=35 Participants
no regional anaesthesia is performed nor saline is injected into the ESP
|
|---|---|---|
|
Post-operative 24 Hour Fentanyl (Intravenous Patient-controlled Analgesia) Use
|
409 Microgram
Interval 221.0 to 636.5
|
349 Microgram
Interval 114.0 to 626.5
|
SECONDARY outcome
Timeframe: First post-operative dayeither presence of nausea or vomiting of any degree counted as yes
Outcome measures
| Measure |
Treatment
n=35 Participants
lumbar ESP block is performed. Before proceeding to ESP block, the back is cleaned with aseptic technique and draped. 40 mL of 0.25% levobupivacaine (or maximum of 2mg/kg body weight made up to same volume) is injected into the ESP.
single shot lumbar Erector Spinae Plane block: unilateral (operative side), performed at L1 level, under ultrasound guidance
|
Control
n=35 Participants
no regional anaesthesia is performed nor saline is injected into the ESP
|
|---|---|---|
|
Post-operative Nausea and Vomiting (PONV)
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: First post-operative daymeasured in medical research council (MRC) grade with 0 being no movement to maximum of 5 meaning normal power
Outcome measures
| Measure |
Treatment
n=35 Participants
lumbar ESP block is performed. Before proceeding to ESP block, the back is cleaned with aseptic technique and draped. 40 mL of 0.25% levobupivacaine (or maximum of 2mg/kg body weight made up to same volume) is injected into the ESP.
single shot lumbar Erector Spinae Plane block: unilateral (operative side), performed at L1 level, under ultrasound guidance
|
Control
n=35 Participants
no regional anaesthesia is performed nor saline is injected into the ESP
|
|---|---|---|
|
Knee Flexion Power (Operative Side)
|
3 score on a scale
Interval 2.0 to 4.0
|
3 score on a scale
Interval 2.0 to 3.0
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment
n=35 participants at risk
lumbar ESP block is performed. Before proceeding to ESP block, the back is cleaned with aseptic technique and draped. 40 mL of 0.25% levobupivacaine (or maximum of 2mg/kg body weight made up to same volume) is injected into the ESP.
single shot lumbar Erector Spinae Plane block: unilateral (operative side), performed at L1 level, under ultrasound guidance
|
Control
n=35 participants at risk
no regional anaesthesia is performed nor saline is injected into the ESP
|
|---|---|---|
|
Injury, poisoning and procedural complications
Prolonged motor block
|
2.9%
1/35 • Number of events 1 • 24 hour post-operatively
|
0.00%
0/35 • 24 hour post-operatively
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place