A Phase 4 interventional study of Levobupivacaine and Ropivacaine in Lower Limb Surgery, sponsored by Aligarh Muslim University. Completed at 1 site in India. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-01-21.
Sponsored by Aligarh Muslim University · Phase 4, Interventional, and Treatment
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.
Aligarh Muslim University is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
intrathecal administration of 15 mg of Levobupivacaine 0.5%
Drug: Levobupivacaine
intrathecal administration of 22.5 mg of Ropivacaine 0.75%
Drug: Ropivacaine
Comparison of Equipotent doses
Also known as: Chirocaine
Comparison of equipotent doses
Also known as: Naropin
Duration of Analgesia
Defined as time for first analgesic request by the patient
Time frame: 8 hours
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
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
Time to Maximum Cephalic Spread of Sensory Block
Time frame: 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).
Time frame: 8 hours
Duration of Motor Block
Time when the Bromage score will be back to zero
Time frame: 8 hours
Pulse Rate, Mean Arterial Pressure, SpO2
Intragroup and intergroup variation compared
Time frame: 8 hours
jawaharlal nehru medical college and hospital
| Milestone | Levobupivacaine 0.5% | Ropivacaine 0.75% |
|---|---|---|
| Started | 30 | 30 |
| Completed | 28 | 30 |
| Not completed | 2 | 0 |
| Withdrew: Failure to achieve adequate block | 2 | 0 |
Defined as time for first analgesic request by the patient
| minutes | Levobupivacaine 0.5% | Ropivacaine 0.75% |
|---|---|---|
| Duration of Analgesia | 309.83 ± 36.45 | 249.50 ± 22.83 |
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.
| minutes | Levobupivacaine 0.5% | Ropivacaine 0.75% |
|---|---|---|
| Onset of Sensory Block at T10 | 13.50 ± 4.94 | 7.33 ± 2.54 |
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.
Results for this outcome have not been posted.
| minutes | Levobupivacaine 0.5% | Ropivacaine 0.75% |
|---|---|---|
| Time to Maximum Cephalic Spread of Sensory Block | 20.33 ± 5.31 | 13.17 ± 3.02 |
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).
| minutes | Levobupivacaine 0.5% | Ropivacaine 0.75% |
|---|---|---|
| Onset of Motor Block to Bromage3 | 12.17 ± 4.09 | 7.83 ± 2.84 |
Time when the Bromage score will be back to zero
| minutes | Levobupivacaine 0.5% | Ropivacaine 0.75% |
|---|---|---|
| Duration of Motor Block | 290.50 ± 34.67 | 222.50 ± 23.00 |
Intragroup and intergroup variation compared
Results for this outcome have not been posted.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Levobupivacaine 0.5% | — | 0/30 (0%) | 11/30 (36.7%) |
| Ropivacaine 0.75% | — | 0/30 (0%) | 13/30 (43.3%) |
| Event | Levobupivacaine 0.5% | Ropivacaine 0.75% |
|---|---|---|
| HypotensionCardiac disorders | 7/30 | 10/30 |
| ShiveringGeneral disorders | 3/30 | 5/30 |
| NauseaGastrointestinal disorders | 4/30 | 2/30 |
| BradycardiaCardiac disorders | 2/30 | 2/30 |
| Age, Continuous(years) | Levobupivacaine 0.5% | Ropivacaine 0.75% | Total |
|---|---|---|---|
| Mean | 38 ± 17 | 35 ± 16 | 37 ± 16 |
| Sex: Female, Male(Participants) | Levobupivacaine 0.5% | Ropivacaine 0.75% | Total |
|---|---|---|---|
| Female | 6 | 7 | 13 |
| Male | 24 | 23 | 47 |
| Region of Enrollment(participants) | Levobupivacaine 0.5% | Ropivacaine 0.75% | Total |
|---|---|---|---|
| India | 30 | 30 | 60 |
| Weight(kg) | Levobupivacaine 0.5% | Ropivacaine 0.75% | Total |
|---|---|---|---|
| Mean | 53.83 ± 9.44 | 57.17 ± 6.65 | 55.5 ± 8.27 |
The record gives a start of Dec 2012, a primary completion of Jan 2014 and a completion of Jan 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2015, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Levobupivacaine · Ropivacaine
Aligarh Muslim University