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The purpose of this study is to compare the effects of two intrathecally administered drugs:0.5% levobupivacaine and0.75%Ropivacaine in spinal anesthesia
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levobupivacaine 0.5% | Active Comparator | intrathecal administration of 15 mg of Levobupivacaine 0.5% |
|
| Ropivacaine 0.75% | Active Comparator | intrathecal administration of 22.5 mg of Ropivacaine 0.75% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobupivacaine | Drug | Comparison of Equipotent doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Analgesia | Defined as time for first analgesic request by the patient | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Pulse Rate, Mean Arterial Pressure, SpO2 | Intragroup and intergroup variation compared | 8 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manazir Athar, M.D | Jawaharlal Nehru Medical College, AMU,Aligarh, India | Principal Investigator |
| Syed Moied Ahmed, PhD, M.D | Jawaharlal Nehru Medical College, AMU, Aligarh, India | Study Director |
| Masood H Siddiqi, M.S | Jawaharlal Nehru Medical College, AMU, Aligarh, India | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jawaharlal Nehru medical college, AMU | Aligarh | Uttar Pradesh | 202002 | India |
Patients who met any of the exclusion criteria or those who did not gave consent were excluded.
jawaharlal nehru medical college and hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Levobupivacaine 0.5% | intrathecal administration of 15 mg of Levobupivacaine 0.5% Levobupivacaine: Comparison of Equipotent doses |
| FG001 | Ropivacaine 0.75% | intrathecal administration of 22.5 mg of Ropivacaine 0.75% Ropivacaine: Comparison of equipotent doses |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Levobupivacaine 0.5% | intrathecal administration of 15 mg of Levobupivacaine 0.5% Levobupivacaine: Comparison of Equipotent doses |
| BG001 | Ropivacaine 0.75% | intrathecal administration of 22.5 mg of Ropivacaine 0.75% Ropivacaine: Comparison of equipotent doses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Analgesia | Defined as time for first analgesic request by the patient | Posted | Mean | Standard Deviation | minutes | 8 hours |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levobupivacaine 0.5% | intrathecal administration of 15 mg of Levobupivacaine 0.5% Levobupivacaine: Comparison of Equipotent doses |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
Exact baricity was not known as Specific gravity was not measured; Quality of anaesthesia was not assessed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Manazir Athar | Jawaharlal Nehru Medical College, AMU, Aligarh, India | +918868056469 | drmanazirathar@gmail.com |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Ropivacaine | Drug | Comparison of equipotent doses |
|
|
| 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. |
| 8 hours |
| Time to Maximum Cephalic Spread of Sensory Block | 8 hours |
| 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). | 8 hours |
| Duration of Motor Block | Time when the Bromage score will be back to zero | 8 hours |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Participants |
|
|
| 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. | Posted | Mean | Standard Deviation | minutes | 30 minutes |
|
|
|
| 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. | Not Posted | 8 hours |
| Secondary | Time to Maximum Cephalic Spread of Sensory Block | Posted | Mean | Standard Deviation | minutes | 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). | Posted | Mean | Standard Deviation | minutes | 8 hours |
|
|
|
| Secondary | Duration of Motor Block | Time when the Bromage score will be back to zero | Posted | Mean | Standard Deviation | minutes | 8 hours |
|
|
|
| Other Pre-specified | Pulse Rate, Mean Arterial Pressure, SpO2 | Intragroup and intergroup variation compared | Not Posted | 8 hours |
| 0 |
| 30 |
| 11 |
| 30 |
| EG001 | Ropivacaine 0.75% | intrathecal administration of 22.5 mg of Ropivacaine 0.75% Ropivacaine: Comparison of equipotent doses | 0 | 30 | 13 | 30 |
| Bradycardia | Cardiac disorders | Systematic Assessment | Heart rate was recorded before induction, every 3 min till 15 minutes, then, every 15 min until discharge from the recovery room.Bradycardia was defined as HR<50 beat/min |
|
| Shivering | General disorders | Non-systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment | Arterial blood pressure was recorded before induction, every 3 min till 15 minutes, then, every 15 min until discharge from the recovery room. Hypotension was defined as systolic BP < 90 mm Hg |
|
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| Aniline Compounds |
| D000588 | Amines |