Trial Outcomes & Findings for Spinal Anesthesia With Hyperbaric Levobupivacaine 0.75% for Ambulatory Knee Arthroscopy (NCT NCT01881087)
NCT ID: NCT01881087
Last Updated: 2017-07-12
Results Overview
Likelihood Rate of motor block persistence after a dosis of spinal HLBP 0.75%
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
180 participants
Primary outcome timeframe
200 minutes
Results posted on
2017-07-12
Participant Flow
Participant milestones
| Measure |
Levo-7.5 mg
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.
|
Levo-9.37
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.
|
Levo-11.25
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
61
|
62
|
|
Overall Study
COMPLETED
|
59
|
61
|
60
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Spinal Anesthesia With Hyperbaric Levobupivacaine 0.75% for Ambulatory Knee Arthroscopy
Baseline characteristics by cohort
| Measure |
Levo-7.5 mg
n=59 Participants
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.
|
Levo-9.37
n=61 Participants
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.
|
Levo-11.25
n=60 Participants
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 13 • n=5 Participants
|
47 years
STANDARD_DEVIATION 13 • n=7 Participants
|
44 years
STANDARD_DEVIATION 12 • n=5 Participants
|
44.3 years
STANDARD_DEVIATION 12 • n=4 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
59 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
180 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Colombia
|
59 participants
n=5 Participants
|
61 participants
n=7 Participants
|
60 participants
n=5 Participants
|
180 participants
n=4 Participants
|
|
Weight
|
74.7 kilograms
STANDARD_DEVIATION 12.3 • n=5 Participants
|
73.3 kilograms
STANDARD_DEVIATION 11.4 • n=7 Participants
|
75.7 kilograms
STANDARD_DEVIATION 13.9 • n=5 Participants
|
74.5 kilograms
STANDARD_DEVIATION 12.5 • n=4 Participants
|
|
Height
|
168 centimeters
STANDARD_DEVIATION 9 • n=5 Participants
|
167 centimeters
STANDARD_DEVIATION 6 • n=7 Participants
|
168 centimeters
STANDARD_DEVIATION 9 • n=5 Participants
|
168 centimeters
STANDARD_DEVIATION 8 • n=4 Participants
|
PRIMARY outcome
Timeframe: 200 minutesLikelihood Rate of motor block persistence after a dosis of spinal HLBP 0.75%
Outcome measures
| Measure |
Levo-7.5 mg
n=59 Participants
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.
|
Levo-9.37
n=61 Participants
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.
|
Levo-11.25
n=60 Participants
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.
|
|---|---|---|---|
|
Probability of Motor Block
|
5 percentage of motor block
|
20 percentage of motor block
|
27 percentage of motor block
|
SECONDARY outcome
Timeframe: 15 minutes after doseFailed Spinal Block Rate for each treatment group
Outcome measures
| Measure |
Levo-7.5 mg
n=59 Participants
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.
|
Levo-9.37
n=61 Participants
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.
|
Levo-11.25
n=60 Participants
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.
Hyperbaric Levobupivacaine 0.75%: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.
|
|---|---|---|---|
|
Failed Spinal Block Rate
|
2 Participants
|
3 Participants
|
1 Participants
|
Adverse Events
Levo-7.5 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Levo-9.37
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Levo-11.25
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. Fredy Ariza, MD., MSc., PhD(a).
Fundación Valle del Lili
Phone: +57 3319090
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place