Lower Limb Surgery
Conditions
Keywords
Subarachnoid block, intrathecal, spinal anesthesia, isobaric, levobupivacaine, ropivacaine
Brief summary
The purpose of this study is to compare the effects of two intrathecally administered drugs:0.5% levobupivacaine and0.75%Ropivacaine in spinal anesthesia
Detailed description
Bupivacaine is a highly cardiotoxic drug and also produces prolonged motor blockade.The newer drugs levobupivacaine and ropivacaine being comparatively less cardio and neurotoxic are preferred now a days.So, we conducted this prospective, randomized double blind study with an aim of comparing the efficacy and characteristics of these drugs.
Interventions
DRUGLevobupivacaine
Comparison of Equipotent doses
DRUGRopivacaine
Comparison of equipotent doses
Sponsors
Aligarh Muslim University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. American Society of Anesthesiologists (ASA) class I & II patients of either sex 2. Age between 18-60 years
Exclusion criteria
1. Patient's refusal. 2. Patients who have contraindications to spinal anaesthesia / Local anaesthetic drugs. 3. Patients having h/o diabetes, neurological and musculoskeletal diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Analgesia | 8 hours | Defined as time for first analgesic request by the patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onset of Sensory Block at T10 | 30 minutes | level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned. |
| Median Maximum Level of Sensory Blockade | 8 hours | level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned. |
| Onset of Motor Block to Bromage3 | 8 hours | Motor block in the lower limbs was graded according to the modified Bromage scale (Grade 0 = No motor block, Grade 1 = Inability to raise extended leg, able to move knees and feet, Grade 2 = Inability to raise extended leg and move knee, able to move feet, Grade 3 = Complete motor block of the lower limbs). Thereafter, It was performed every 5 minutes till the attainment of MB grade 3 followed by every 30 minutes until complete recovery (MB grade0). |
| Duration of Motor Block | 8 hours | Time when the Bromage score will be back to zero |
| Time to Maximum Cephalic Spread of Sensory Block | 8 hours | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pulse Rate, Mean Arterial Pressure, SpO2 | 8 hours | Intragroup and intergroup variation compared |
Countries
India
Participant flow
Recruitment details
jawaharlal nehru medical college and hospital
Pre-assignment details
Patients who met any of the exclusion criteria or those who did not gave consent were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Levobupivacaine 0.5% intrathecal administration of 15 mg of Levobupivacaine 0.5%
Levobupivacaine: Comparison of Equipotent doses | 30 |
| Ropivacaine 0.75% intrathecal administration of 22.5 mg of Ropivacaine 0.75%
Ropivacaine: Comparison of equipotent doses | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Failure to achieve adequate block | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Levobupivacaine 0.5% | Ropivacaine 0.75% |
|---|---|---|---|
| Age, Continuous | 37 years STANDARD_DEVIATION 16 | 38 years STANDARD_DEVIATION 17 | 35 years STANDARD_DEVIATION 16 |
| Region of Enrollment India | 60 participants | 30 participants | 30 participants |
| Sex: Female, Male Female | 13 Participants | 6 Participants | 7 Participants |
| Sex: Female, Male Male | 47 Participants | 24 Participants | 23 Participants |
| Weight | 55.5 kg STANDARD_DEVIATION 8.27 | 53.83 kg STANDARD_DEVIATION 9.44 | 57.17 kg STANDARD_DEVIATION 6.65 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 30 | 13 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Duration of Analgesia
Defined as time for first analgesic request by the patient
Time frame: 8 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Levobupivacaine 0.5% | Duration of Analgesia | 309.83 minutes | Standard Deviation 36.45 |
| Ropivacaine 0.75% | Duration of Analgesia | 249.50 minutes | Standard Deviation 22.83 |
Secondary
Duration of Motor Block
Time when the Bromage score will be back to zero
Time frame: 8 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Levobupivacaine 0.5% | Duration of Motor Block | 290.50 minutes | Standard Deviation 34.67 |
| Ropivacaine 0.75% | Duration of Motor Block | 222.50 minutes | Standard Deviation 23 |
Secondary
Median Maximum Level of Sensory Blockade
level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.
Time frame: 8 hours
Secondary
Onset of Motor Block to Bromage3
Motor block in the lower limbs was graded according to the modified Bromage scale (Grade 0 = No motor block, Grade 1 = Inability to raise extended leg, able to move knees and feet, Grade 2 = Inability to raise extended leg and move knee, able to move feet, Grade 3 = Complete motor block of the lower limbs). Thereafter, It was performed every 5 minutes till the attainment of MB grade 3 followed by every 30 minutes until complete recovery (MB grade0).
Time frame: 8 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Levobupivacaine 0.5% | Onset of Motor Block to Bromage3 | 12.17 minutes | Standard Deviation 4.09 |
| Ropivacaine 0.75% | Onset of Motor Block to Bromage3 | 7.83 minutes | Standard Deviation 2.84 |
Secondary
Onset of Sensory Block at T10
level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Levobupivacaine 0.5% | Onset of Sensory Block at T10 | 13.50 minutes | Standard Deviation 4.94 |
| Ropivacaine 0.75% | Onset of Sensory Block at T10 | 7.33 minutes | Standard Deviation 2.54 |
Secondary
Time to Maximum Cephalic Spread of Sensory Block
Time frame: 8 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Levobupivacaine 0.5% | Time to Maximum Cephalic Spread of Sensory Block | 20.33 minutes | Standard Deviation 5.31 |
| Ropivacaine 0.75% | Time to Maximum Cephalic Spread of Sensory Block | 13.17 minutes | Standard Deviation 3.02 |
Other Pre-specified
Pulse Rate, Mean Arterial Pressure, SpO2
Intragroup and intergroup variation compared
Time frame: 8 hours