Table of Content - Volume 7 Issue 3 -September 2018

 

 

A randomized, prospective, comparative study to evaluate the haemodynamic changes of 3ml of 0.5% isobaric levobupivacaine and 3ml of 0.5% isobaric ropivacaine for spinal anaesthesia in patients undergoing elective lower limb orthopaedic surgeries

 

Suresh S B¹, Prasanna Kumara V R^2*

 

 

Abstract               Background: Levobupivacaine and Ropivacaine have been recently introduced in India, Although levobupivacaine is theoretically more potent than ropivacaine, clinical studies show conflicting results in terms of anesthetic and analgesic characteristics. Many studies have showed that equipotent doses of ropivacaine and levobupivacaine have similar efficacy in peripheral nerve plexus block and epidural anesthesia in ambulatory patients, as well as when administered by topical application or local infiltration. Not many studies have been done in India comparing the use of isobaric Levobupivacaine 0.5% and isobaric Ropivacaine 0.5% for spinal anaesthesia. Hence the present study was undertaken to evaluate the haemodynamic changes of 3ml of 0.5% isobaric levobupivacaine and 3ml of 0.5% isobaric ropivacaine for spinal anaesthesia in patients undergoing elective lower limb orthopaedic surgeries. Materials and Methods: Group A (n=30) received Levobupivacaine 0.5% and group B (n=30) Ropivacaine0.5%. Heart Rate, SBP, DBP, MAP were recorded at various time intervals Results: There is no statistically significant difference in the mean heart rate and the mean diastolic blood pressure between the two groups at various time intervals. There is no statistically significant difference between the two groups for mean systolic blood pressure except at 80^th and 90th minutes. Clinically there was no significant hypotension necessitating the administration of injection mephenteremine. There is no statistically significant difference in mean arterial pressure between the two groups except at 70^th, 80^th and 90^th minutes. Conclusion: There was no statistically significant difference in heart rate, DBP monitored at various intervals between the 0.5% isobaric Levobupivacaine (15 mg) group and 0.5% isobaric Ropivacaine (15 mg) groups in patients undergoing elective lower limb orthopaedic surgeries. Though inter group difference in SBP at 80^th and 90^th min and in MAP at 70^th, 80^th and 90^th min was statistically significant, it was clinically insignificant as there was no need to use vasopressor.

Key Words: Levobupivacaine, Ropivacaine, Haemodynamic changes, intrathecal anaesthesia.

 

 

 

 

 

 

INTRODUCTION

Regional anesthesia is frequently used for extremity surgeries to optimize severe intraoperative and postoperative pain relief.¹ Concerns over racemic bupivacaine have been raised over its potential cardiotoxicity and central nervous system (CNS) toxicity.^2,3 Ropivacaine or levobupivacaine emerged at the right moment, both of which are the pure left-isomers of bupivacaine and quite similar in physicochemical properties. Both are associated with lower cardiac and CNS toxicity to offer a safer alternative to bupivacaine. Although levobupivacaine is theoretically more potent than ropivacaine, clinical studies show conflicting results in terms of anesthetic and analgesic characteristics. Many studies have showed that equipotent doses of ropivacaine and levobupivacaine have similar efficacy in peripheral nerve plexus block and epidural anesthesia in ambulatory patients, as well as when administered by topical application or local infiltration.^4,5 So, further critical evidence is needed to complete clinical application guidance. Levobupivacaine and Ropivacaine have been recently introduced in India, not many studies have been done in India comparing the use of isobaric Levobupivacaine 0.5% and isobaric Ropivacaine 0.5% for spinal anaesthesia. Hence the present study was undertaken to evaluate the haemodynamic changes of 3ml of 0.5% isobaric levobupivacaine and 3ml of 0.5% isobaric ropivacaine for spinal anaesthesia in patients undergoing elective lower limb orthopaedic surgeries.

 

AIM AND OBJECTIVES

To evaluate haemodynamic changes of 3ml of 0.5% isobaric Levobupivacaine and 3ml of 0.5% isobaric Ropivacaine for spinal anaesthesia in subjects undergoing elective lower limb orthopaedic surgeries.

MATERIALS AND METHODS

A prospective, randomized, comparative study was undertaken from December 2014 to June 2015 to evaluate the haemodynamic changes of intrathecal 0.5% isobaric Levobupivacaine and 0.5% isobaric Ropivacaine in patients undergoing elective lower limb orthopaedic surgery at bgs global Hospitals, Bengaluru. Sixty patients of ASA class I and II of age group 18 to 65 years posted for elective lower limb surgeries were divided into two groups- group A (n=30) received Levobupivacaine 0.5% and group B (n=30) Ropivacaine 0.5%, using computer generated random number chart. Heart Rate (HR), Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Mean arterial pressure(MAP) were recorded at various time intervals. Data were tabulated and analyzed using SPSS 16.0 software. Descriptive statistics such as mean and standard deviation (SD) were used for continuous variables, median and range for non-normally distributed variables and categorical variables were summarized using percentages. Chi-Square Test, Fisher’s exact test was used.

Inclusion Criteria: Adult subjects of either gender, aged between 18-65years, belonging to ASA Class I and II scheduled for elective lower limb orthopaedic surgeries of duration less than 180 minutes were included in the study.

Exclusion Criteria: Subjects belonging to the following classes pregnancy, ASA class III and IV, subjects posted for Emergency surgeries, subjects with body mass index more than 29.9kg/m² , subjects shorter than 150 cm and longer than 180 cm. The study was conducted after scientific and institutional ethical committee approval and after taking informed written consent from all patients.

Group A: patients received 3ml (15mg) of 0.5% isobaric levobupivacaine.

Group B: patients received 3ml (15mg) of 0. 5% isobaric Ropivacaine.                                                                 

Under aseptic precautions lumbar puncture was performed at the level of L3-L4 through a midline approach using 26 G Quincke’s spinal needle and study drug was injected after confirmation of needle tip in the subarachnoid space by free flow of CSF. Patients were made to lie down in the supine posture immediately, with the table kept flat horizontally and supplementary oxygen was given. Heart Rate (HR), Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Mean arterial pressure (MAP) were recorded at various time intervals.            

 

RESULTS AND OBSERVATIONS

The mean age in Levobupivacaine 0.5% (group A) is 39.33±15.858 and in Ropivacaine 0.5% (group B) is 35.40±14.357. Group A had 21 male and 9 female patients, group B had 24 male and 6 female patients. Group A mean height was 160.93 ± 5.010 cms, Group B mean height was 161.57 ± 4.446 cms. The mean body weight in group A is 61.63±5.774 kgs and in group B is 61.43±6.579 kgs. The mean body mass index in group A is 23.80±1.659 kg/m² and in group B is 23.53±2.130 kg/m². The number of patients undergoing various types of lower limb orthopaedic procedures among the groups were Arthroscopic ACL reconstruction group A 7 (23.3%) and group B 10 (33.3%), Intramedulary nailing group A 14 (46.7%)and group B 14 (46.7%), Implant removal group A 6 (20%)and group B 3(10%), Total hip replacement group A 1(3.3%) and group B 2 (6.7%), Total knee replacement group A 2 (6.7%) and group B 1 (3.3%). ASA Class I group A had 19 (63.3%) and group B had 25 (83.3%) patients, ASA Class II group A had 11 (36.7%) and group B had 5 (16.7%) patients.

 

Table 1: Mean Heart Rate (bpm) at various time intervals

HR80	Group A	78.20	9.488	0.855
	Group B	78.63	8.795
HR90	Group A	76.23	6.872	0.330
	Group B	78.27	9.021
HR100	Group A	76.83	7.144	0.724
	Group B	77.57	8.795
HR120	Group A	78.87	7.789	0.612
	Group B	77.83	7.927

Table 1 shows the mean heart rate at various time intervals between the two groups. There is no statistically significant difference in the mean heart rate between the two groups at various time intervals.

 

Table 2: Mean SBP at various time (mins) intervals in mmHg

Group B	113.90	7.457
SBP40	Group A	114.00	6.330	0.986
	Group B	114.03	8.352
SBP50	Group A	114.23	7.210	0.710
	Group B	115.00	8.602
SBP60	Group A	114.53	7.295	0.309
	Group B	116.60	8.282
SBP70	Group A	113.53	6.892	0.060
	Group B	117.40	8.589
SBP80	Group A	114.23	6.527	0.007
	Group B	119.80	8.782
SBP90	Group A	114.13	6.208	0.023
	Group B	118.57	8.282
SBP100	Group A	116.57	5.444	0.209
	Group B	118.87	8.270
SBP120	Group A	116.23	7.060	0.191
	Group B	118.77	7.762

Table 2 represents the mean systolic blood pressure at various time intervals between the two groups. There is no statistically significant difference between the two groups except at 80^th and 90th minutes. Clinically there was no significant hypotension necessitating the administration of injection mephenteremine.

 

Table 3: Mean DBP at various time (mins) intervals in mmHg

DBP2	Group A	74.10	6.194	0.987
	Group B	74.07	8.944
DBP5	Group A	71.43	5.987	0.880
	Group B	71.17	7.534
DBP10	Group A	70.30	5.814	0.403
	Group B	68.77	8.089
DBP20	Group A	69.27	5.514	0.312
	Group B	67.73	6.113
DBP30	Group A	68.30	4.872	0.258
	Group B	66.63	6.327
DBP40	Group A	67.87	4.049	0.512
	Group B	66.97	6.272
DBP50	Group A	67.67	4.498	0.571
	Group B	66.87	6.230
DBP60	Group A	68.07	3.695	0.981
	Group B	68.03	6.515
DBP70	Group A	67.80	3.764	0.073
	Group B	70.03	5.537
DBP80	Group A	67.10	4.604	0.097
	Group B	69.73	7.211
DBP90	Group A	68.30	3.271	0.216
	Group B	70.00	6.644
DBP100	Group A	69.20	3.010	0.831
	Group B	69.47	6.124
DBP120	Group A	69.30	4.496	0.811
	Group B	69.63	6.150

Table 3 shows the mean diastolic blood pressure at various time intervals between the two groups. There is no statistically significant difference in diastolic blood pressure between the two groups.

 

Table 4: Mean MAP at various time(mins) intervals in mmHg

Table 4 represents the mean MAP at various time intervals. There is no statistically significant difference in mean arterial pressure between the two groups except at 70^th, 80^th and 90^th minutes.

Adverse effects: There was no incidence of nausea, vomiting, headache, shivering, SpO₂<93%, hypotension, bradycardia in any patient in both the study groups.

                         

DISCUSSION

A study entitled “A prospective, randomized, comparative clinical study of effect of 0.5% isobaric Levobupivacaine and 0.5% isobaric Ropivacaine for spinal anaesthesia in patients undergoing elective lower limb orthopaedic surgeries” was undertaken in BGS Global Hospital, Bengaluru from December 2014 to June 2015 to evaluate the haemodynamic changes. With respect to age and gender distribution, height and weight of the patients and the nature of surgical procedure were similar in both the groups and there was no statistically significant difference among the groups.

Heart Rate: There is no statistically significant difference in the heart rate between the two groups at various time intervals. There was no incidence of bradycardia in any group. Our results concur with the results of most of the studies.

Blood Pressure: There was a marginal fall in mean systolic blood pressure in both Levobupivacaine and Ropivacaine group. Statistically significant difference in SBP was observed at 80^th and 90^th minutes but it was not clinically significant requiring the use of vasopressor. There was neither statistically nor clinically significant difference in DBP between the two groups. There was statistically significant difference in MAP between two groups at 70^th, 80^th and 90^th minutes but it was not clinically significant. This was probably due to preloading with 500 ml of ringer’s lactate and lower limb tourniquet application. Our results correlate with results of Casati A et al.⁶ and Mantouvalou et al.⁷ In a study by Amartya Khan et al.⁸ it was concluded that both 0.5% levobupivacaine and 0.75% ropivacaine are potent enough to carry out lower limb surgeries with stable hemodynamic parameters. They exhibited comparable hemodynamic response with heart rate, systolic and diastolic blood pressure being stable and comparable without any statistical difference which correlate with our study. In a study Manazir Athar et al.⁹ Baseline haemodynamic parameters were comparable in both levobupivacaine and ropivacaine groups. The mean MAP decreased significantly in both the groups compared to baseline/preoperative values (p < 0.05) but overall incidence of hypotension was not significantly different. Furthermore, it was transient (30 min) in ropivacaine group compared to levobupivacaine which was sustained (100 min). There were no significant differences between the two groups with respect to PR and SpO₂ (p > 0.05). Hypotension was the most common side effect seen in both the groups, however, total amount of mephentermine used was significantly not different (p >0.05). The results are comparable to our present study.

Adverse effects: No adverse effects attributable to the intrathecal drugs were noticed in any patient in both the groups. This is similar to the studies of Mantouvalou et al.⁷

 

CONCLUSION

From the present study we can conclude that there was no statistically significant difference in heart rate, DBP monitored at various intervals between the 0.5% isobaric Levobupivacaine (15 mg) group and 0.5% isobaric Ropivacaine (15 mg) groups in patients undergoing elective lower limb orthopaedic surgeries. Though inter group difference in SBP at 80^th and 90^th min and in MAP at 70^th, 80^th and 90^th min was statistically significant, it was clinically insignificant as there was no need to use vasopressor.

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