Anesthesia, Disorder of Knee
Conditions
Keywords
Knee Arthroscopy, Levobupivacaine, Spinal Anesthesia, Motor Block
Brief summary
The purpose of this study is to evaluate motor block probability throughout time and clinical profile when using three different doses of HLBP 0.75% (7.5, 9.37 and 11.25 mg) by a unilateral spinal block technique.
Detailed description
Previous IRB approval and informed consent, 180 ASA I-II adults under ambulatory knee arthroscopy will be randomly allocated to receive unilateral spinal anesthesia with 7.5 (group Levo-7.5, n=59), 9.37(group Levo-9.37, n=61) and 11.25 (group Levo-11.25, n=60) mg of HLBP 0.75% using a 27-gauge Whitacre needle at a rate of 0.1 ml/ seg. and lateral decubitus position maintained for 5 min after injection. An independent observer will evaluate motor (modified Bromage scale) and sensory (transcutaneal electrical stimulation at T10, L1, L3, and S1 dermal segments) levels and presence of adverse events immediately after return to supine, at the end of surgery and each 10 min from admission to PACU until home discharge conditions. Trans-cutaneal electrical stimulation (TES) will be made with a PNS (Ministim® model MS- IV, Organon, Dublin, Irland) using 50-Hz tetanus stimuli for 5 seg. from 10 to 60 mA 3,4.
Interventions
DRUGHyperbaric 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.
Sponsors
Fundacion Clinica Valle del Lili
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18-64 y.o. scheduled for knee arthroscopy (therapeutic or diagnostic)
Exclusion criteria
* Cardiac or pulmonary disease * Antiplatelet or anticoagulant drugs use during 7 days before surgery * History of coagulative disorders * Bilateral procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probability of Motor Block | 200 minutes | Likelihood Rate of motor block persistence after a dosis of spinal HLBP 0.75% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Failed Spinal Block Rate | 15 minutes after dose | Failed Spinal Block Rate for each treatment group |
Countries
Colombia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 59 |
| 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. | 61 |
| 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. | 60 |
| Total | 180 |
Baseline characteristics
| Characteristic | Levo-7.5 mg | Levo-9.37 | Levo-11.25 | Total |
|---|---|---|---|---|
| Age, Continuous | 42 years STANDARD_DEVIATION 13 | 47 years STANDARD_DEVIATION 13 | 44 years STANDARD_DEVIATION 12 | 44.3 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 59 Participants | 61 Participants | 60 Participants | 180 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 168 centimeters STANDARD_DEVIATION 9 | 167 centimeters STANDARD_DEVIATION 6 | 168 centimeters STANDARD_DEVIATION 9 | 168 centimeters STANDARD_DEVIATION 8 |
| Region of Enrollment Colombia | 59 participants | 61 participants | 60 participants | 180 participants |
| Sex: Female, Male Female | 32 Participants | 28 Participants | 32 Participants | 92 Participants |
| Sex: Female, Male Male | 27 Participants | 33 Participants | 28 Participants | 88 Participants |
| Weight | 74.7 kilograms STANDARD_DEVIATION 12.3 | 73.3 kilograms STANDARD_DEVIATION 11.4 | 75.7 kilograms STANDARD_DEVIATION 13.9 | 74.5 kilograms STANDARD_DEVIATION 12.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 61 | 0 / 60 |
| other Total, other adverse events | 0 / 59 | 0 / 61 | 0 / 60 |
| serious Total, serious adverse events | 0 / 59 | 0 / 61 | 0 / 60 |
Outcome results
Primary
Probability of Motor Block
Likelihood Rate of motor block persistence after a dosis of spinal HLBP 0.75%
Time frame: 200 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levo-7.5 mg | Probability of Motor Block | 5 percentage of motor block |
| Levo-9.37 | Probability of Motor Block | 20 percentage of motor block |
| Levo-11.25 | Probability of Motor Block | 27 percentage of motor block |
Secondary
Failed Spinal Block Rate
Failed Spinal Block Rate for each treatment group
Time frame: 15 minutes after dose
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Levo-7.5 mg | Failed Spinal Block Rate | 2 Participants |
| Levo-9.37 | Failed Spinal Block Rate | 3 Participants |
| Levo-11.25 | Failed Spinal Block Rate | 1 Participants |