A double-blind study on the efficacy and safety of spinal ropivacaine 0.75 percent compared to spinal bupivacaine 0.5 percent in patients undergoing lower limb surgery
- Author:
Layo Marinelle Nuguid
;
Huerto Antonio Petronio Simpao
;
Vera Marie Jeanne
;
Cruz Ma. Concepcion Luis
- Publication Type:Journal Article
- MeSH:
Human;
Aged;
Middle Aged;
Adult;
Young Adult;
Adolescent;
ANESTHESIA, SPINAL;
ROPIVACAINE;
BUPIVACAINE;
ANESTHETICS, LOCAL
- From:
Philippine Journal of Anesthesiology
2002;14(1):15-22
- CountryPhilippines
- Language:English
-
Abstract:
Background: Ropivacaine is a new amino-amide local anesthetic structurally related to bupivacaine. It is a potent, long acting local anesthetic with lower toxicity and a wider safety of margin than bupivacaine. This drug however is still under clinical investigation. Studies of ropivacaine for spinal anesthesia in humans are still in their early stage. Therefore, the authors embarked on this randomized, double-blind study to examine the clinical efficacy and safety of ropivacaine 0.75 percent versus bupivacaine 0.5 percent as used in spinal anesthesia
Methodology: Fifty adult patients were randomized to receive either ropivacaine 0.75 percent or bupivacaine 0.5 percent given intrathecally. Baseline vital signs (heart rate and blood pressure) were measured before, during, and after surgery. Onset as well as duration of action of the study drugs were measured and side effects noted. Bromage Scale was also measured for all patients. The subjects as well as the investigators were unaware of the drug being given.
Results: Using independent t-test, there was no difference seen between treatment groups for onset of action (p value =0.912) and duration of action (p value=0.349). Using repeated measures analysis of variance test for significance, also showed no difference between treatment groups with the vital signs, systolic blood pressure (p value=0.183), diastolic blood pressure (p value= 0.489) and heart rate (p value=0.374). However, using multiple contrasts of the different time readings showed significant findings in systolic and diastolic blood pressure readings as well as the heart rate readings. For the side effects, only four were noted for the population, and these are hypotension, hypertension, tachycardia and bradycardia. Fishers exact test showed insignificant finding, however, most of the cases with side effects occurred in bupivacaine.
Conclusion: Ropivacaine 0.75 percent given intrathecally is a safe and efficacious alternative to bupivacaine 0.5 percent showing less cardiovascular side effects.
