RESULTS It is a prospective randomized controlled study with 80 patients randomly divided into two groups of 40 patients each

RESULTS
It is a prospective randomized controlled study with 80 patients randomly divided into two groups of 40 patients each, using www.random.org.

Group C – received intrathecal 0.75% plain ropivacaine
Group D – received intrathecal 0.75% hyperbaric ropivacainePatients were evaluated for onset and duration of sensory and motor blockade, dermatomal level achieved, hemodynamic variations and side effects of the drug if any.

Demography:
Table 5: Gender distribution comparison between two groups
Group
Plain RopivacaineHyperbaric RopivacaineCount % Count %
Gender Female 20 50.0% 20 50.0%
Male 20 50.0% 20 50.0%
? 2 = 0.001, df = 1, p = 1.000
In Plain Ropivacaine and Hyperbaric Ropivacaine group, 50% were males and 50% were females. There was no difference in Gender between two groups.

Fig 8: Bar diagram showing Gender distribution comparison between two groups
Table 6 : Age distribution comparison between two groups
Group
Plain RopivacaineHyperbaric RopivacaineCount % Count %
Age <30 years 14 35.0% 5 12.5%
31 to 40 years 7 17.5% 8 20.0%
41 to 50 years 10 25.0% 14 35.0%
51 to 60 years 9 22.5% 13 32.5%
Mean ± SD 39.50 ± 11.752 44.18 ± 10.546
? 2 = 5.724, df = 3, p = 0.126
In Plain Ropivacaine group mean age group, 39.50 ± 11.75 years and in Hyperbaric Ropivacaine group mean age group, 44.18 ± 10.546 years. There was no significant difference in mean age between two groups.

Fig 9: Bar diagram showing Age distribution comparison between two groups
Table 7 : Weight and Height distribution comparison between two groups
Group N Mean SD SE
Weight Plain Ropivacaine40 62.98 6.306 0.013*
Hyperbaric Ropivacaine40 59.68 5.274 Height Plain Ropivacaine40 158.38 3.102 0.004*
Hyperbaric Ropivacaine40 156.38 2.976 In Plain Ropivacaine group mean weight was 62.98 ± 6.306 kgs and in Hyperbaric Ropivacaine group mean weight was 59.68 ± 5.274 kgs. There was significant difference in mean weight between two groups.
In Plain Ropivacaine group mean height was 158.38 ± 3.102 cms and in Hyperbaric Ropivacaine group mean weight was 156.38 ± 2.976 cms. There was significant difference in mean height between two groups.

Fig 10: Bar diagram showing Weight and Height distribution comparison between two groups
Table 8 : ASA grade comparison between two groups
Group
Plain RopivacaineHyperbaric Ropivacaine Count % Count %
ASA grade 1 28 70.0% 20 50.0%
2 12 30.0% 20 50.0%
? 2 = 3.333, df = 1, p = 0.068
In Plain Ropivacaine group, 70% had ASA grade 1 and 30% had ASA grade 2. In Hyperbaric Ropivacaine group, 50% had ASA grade 1 and 50% had ASA grade 2. There was no significant difference in ASA grade between two groups.

Fig 11: Bar diagram showing ASA grade comparison between two groups
Table 9 : Heart rate comparison between two groups at different time intervals
HR Group P value b/w two groups
Plain RopivacaineHyperbaric RopivacaineMean SD P value with in group Mean SD P value with in group Baseline 79.6 8.9 80.8 6.4 0.473
1 min 79.5 8.3 0.934 80.2 5.7 0.077 0.696
3 min 79.6 8.2 0.855 79.6 5.6 0.022* 0.975
5 min 79.9 8.6 0.446 79.2 5.5 0.005* 0.675
10 min 79.9 8.3 0.496 79.6 5.8 0.064 0.840
15 min 79.3 7.9 0.604 78.9 6.1 0.009* 0.813
20 min 79.5 7.6 1.000 78.9 5.3 0.007* 0.657
25 min 79.1 7.3 0.458 78.8 5.2 0.007* 0.820
30 min 79.3 7.4 0.648 78.8 5.0 0.007* 0.752
40 min 78.6 7.0 0.108 79.3 5.1 0.056 0.637
50 min 78.8 7.1 0.176 79.3 4.9 0.035* 0.729
1 hr 78.5 7.3 0.044* 78.6 5.6 0.001* 0.932
2hr 78.3 7.4 0.020* 79.0 6.1 0.011* 0.668
6 hr 78.5 7.4 0.033* 78.8 6.1 0.008* 0.831
12 hr 78.6 7.1 0.079 78.5 5.4 0.005* 0.944
24 hr 78.3 7.0 0.029* 78.6 5.0 0.003* 0.840
In the study there was no significant difference in mean Heart rate between two groups at all the intervals of followup.
In Plain Ropivacaine, there was significant difference in mean HR at 1 hr, 2 hr, 6 hr and 24 hr compared to baseline values.
In Hyperbaric Ropivacaine, there was significant difference in mean HR at 3 min, 5min, 15 min, 20 min, 30 min, 50 min, 1 hr, 2 hr, 6 hr, 12 hr and 24 hr compared to baseline values.

Fig 12: Line diagram showing Heart rate comparison between two groups at
different time intervals
Table 10 : SBP comparison between two groups at different time intervals
SBP Group P value
Plain RopivacaineHyperbaric RopivacaineMean SD P value with in Group Mean SD P value with in Group Baseline 121.6 12.8 120.2 21.6 0.744
1 min 120.6 12.4 0.016* 121.5 13.5 0.611 0.744
3 min 119.7 12.2 0.002* 119.4 13.8 0.721 0.912
5 min 117.5 11.9 <0.001* 117.0 13.7 0.209 0.869
10 min 115.6 11.5 <0.001* 115.1 13.1 0.056 0.885
15 min 113.6 11.4 <0.001* 113.3 13.2 0.011* 0.892
20 min 112.2 11.5 <0.001* 111.6 13.1 0.002* 0.828
25 min 110.7 11.5 <0.001* 111.6 12.9 0.002* 0.743
30 min 110.4 11.1 <0.001* 112.1 12.6 0.004* 0.512
40 min 110.6 10.9 <0.001* 112.8 12.8 0.007* 0.421
50 min 111.2 11.7 <0.001* 114.2 13.1 0.027* 0.292
1 hr 111.5 11.2 <0.001* 115.1 13.1 0.058 0.195
2 hr 113.9 11.4 <0.001* 116.1 13.0 0.140 0.403
6hr 115.5 10.9 <0.001* 117.4 13.5 0.284 0.507
12 hr 116.4 11.4 <0.001* 119.3 12.8 0.710 0.296
24 hr 117.0 10.9 <0.001* 119.7 13.4 0.850 0.321
In the study there was no significant difference in mean SBP between two groups at all the intervals of followup.
In Plain Ropivacaine group there was significant difference in mean SBP from 1 min to 24 hrs compared to baseline. Initially there was decrease in SBP and after 40 min SBP started to increase towards baseline value.
In Hyperbaric Ropivacaine group there was significant difference in mean SBP from 15 min to 50 min compared to baseline. Initially there was decrease in SBP and after 25min SBP started to increase towards baseline value.

Fig 13: Line diagram showing SBP comparison between two groups at different time intervals
Table 11: DBP comparison between two groups at different time intervals
DBP Group P value b/w two groups
Plain RopivacaineHyperbaric RopivacaineMean SD P value within the group Mean SD P value within the group Baseline 77.8 7.3 81.2 8.6 0.060
1 min 78.0 8.3 0.557 80.2 8.8 <0.001* 0.269
3 min 77.0 8.0 0.111 78.8 8.7 <0.001* 0.353
5 min 75.0 7.2 <0.001* 77.1 8.9 <0.001* 0.227
10 min 74.1 7.3 <0.001* 75.4 8.8 <0.001* 0.449
15 min 72.3 6.8 <0.001* 73.9 8.9 <0.001* 0.385
20 min 70.9 7.1 <0.001* 73.1 8.9 <0.001* 0.238
25 min 69.8 6.9 <0.001* 72.7 8.4 0.002* 0.091
30 min 69.1 6.9 <0.001* 73.0 7.6 0.002* 0.021*
40 min 69.6 6.6 0.522 73.6 7.8 0.002* 0.015*
50 min 71.0 6.9 <0.001* 74.6 7.7 <0.001* 0.03*
1 hr 70.5 7.2 0.028* 75.3 7.9 <0.001* 0.007*
2 hr 71.9 6.8 0.017* 76.2 8.0 <0.001* 0.011*
6 hr 72.1 7.0 0.017* 76.7 7.9 <0.001* 0.007*
12 hr 72.8 6.3 0.015* 77.9 8.2 <0.001* 0.003*
24 hr 73.9 6.8 <0.001* 78.3 7.5 <0.001* 0.008*
In the study there was significant difference in mean DBP between two groups from 30 min to 24 hrs. At these intervals mean DBP was significantly higher in Hyperbaric Ropivacaine group. At other intervals there was no significant difference in mean DBP between two groups.
In Plain Ropivacaine group there was significant difference in mean DBP from 5 min to 24 hrs compared to baseline. Initially there was decrease in DBP and after 40 min DBP started to increase towards baseline value.
In Hyperbaric Ropivacaine group there was significant difference in mean DBP from 1 min to 24 hrs compared to baseline. Initially there was decrease in DBP and after 30 min DBP started to increase towards baseline value.

Fig 14: Line diagram showing DBP comparison between two groups at different time intervals
Table 12 : MAP comparison between two groups at different time intervals
MAP Group P value
Plain RopivacaineHyperbaric RopivacaineMean SD P value within the group Mean SD P value within the group Baseline 91.1 10.5 94.3 9.9 0.171
1 min 91.4 9.0 0.725 93.2 9.6 <0.001* 0.397
3 min 90.9 9.1 0.711 91.8 9.6 <0.001* 0.668
5 min 88.9 8.4 0.006* 90.0 9.9 <0.001* 0.602
10 min 87.8 8.3 <0.001* 88.5 10.0 <0.001* 0.734
15 min 85.9 8.0 <0.001* 86.5 9.5 <0.001* 0.761
20 min 84.5 8.2 <0.001* 85.5 9.7 <0.001* 0.629
25 min 83.3 8.0 <0.001* 85.2 9.3 <0.001* 0.318
30 min 82.5 8.1 <0.001* 85.4 9.0 <0.001* 0.133
40 min 83.2 7.7 <0.001* 86.1 9.1 <0.001* 0.134
50 min 84.3 8.2 <0.001* 86.9 9.1 <0.001* 0.191
1 hr 84.0 8.2 <0.001* 87.9 9.3 <0.001* 0.048*
2 hr 85.5 7.9 <0.001* 88.9 9.3 <0.001* 0.082
6 hr 86.7 8.1 <0.001* 89.7 9.2 <0.001* 0.123
12 hr 87.3 7.8 <0.001* 91.0 9.2 <0.001* 0.057
24 hr 88.3 7.8 0.004* 91.5 9.3 <0.001* 0.099
In the study there was no significant difference in mean MAP between two groups at all the intervals except at 1 hr.
In Plain Ropivacaine group there was significant difference in mean MAP from 5 min to 24 hrs compared to baseline. Initially there was decrease in DBP and after 30 min DBP started to increase towards baseline value.
In Hyperbaric Ropivacaine group there was significant difference in mean MAP from 1min to 24 hrs compared to baseline. Initially there was decrease in DBP and after 25 min DBP started to increase towards baseline value.

Fig15: Line diagram showing MAP comparison between two groups at different time intervals
Table 13 : SpO2 comparison between two groups at different time intervals
SpO2 Group P value b/w two groups
Plain RopivacaineHyperbaric RopivacaineMean SD P value within the group Mean SD P value within the group Baseline 99.4 0.7 99.6 0.5 0.220
1 min 99.8 0.5 0.038* 99.7 0.5 0.352 0.824
3 min 99.8 0.4 0.038* 99.8 0.4 0.135 0.796
5 min 99.9 0.3 <0.001* 99.8 0.5 0.281 0.052
10 min 99.8 0.4 0.009* 99.9 0.3 0.006* 0.215
15 min 99.8 0.4 0.014* 99.8 0.4 0.058 0.778
20 min 99.9 0.3 0.002* 99.7 0.4 0.230 0.140
25 min 99.9 0.3 0.002* 99.9 0.3 0.006 1.000
30 min 99.8 0.4 0.004* 99.9 0.3 0.003* 0.336
40 min 99.8 0.4 0.011* 99.9 0.2 0.001* 0.043*
50 min 99.8 0.5 0.006* 99.9 0.3 0.011* 0.410
1 hr 99.8 0.5 0.022* 99.8 0.4 0.281 0.819
2 hr 99.6 0.6 0.418 99.7 0.6 0.352 0.264
6 hr 99.5 0.7 0.637 99.6 0.6 0.643 0.735
12 hr 99.5 0.6 0.860 99.5 0.8 0.309 1.000
24 hr 99.1 0.8 0.02* 99.2 0.7 0.012* 0.394
In the study there was no significant difference in mean SpO2 between two groups at all the intervals except at 40 min.
In Plain Ropivacaine group there was significant difference in mean SpO2 from 1 min to 1hr compared to baseline. Initially there was increase in SpO2 and after 2hr SpO2 started to decrease towards baseline value.
In Hyperbaric Ropivacaine group there was significant difference in mean SpO2 at 10 min, 30 min to 50 min and at 24 hrs compared to baseline.

Fig 16: Line diagram showing SpO2 comparison between two groups at
different time intervals
Table 14 : Modified Bromage Score comparison between two groups at different time intervals
MBS Group P value
Plain RopivacaineHyperbaric RopivacaineMean SD Median P value within the group Mean SD Median P value within the group Baseline 0.0 0.0 0 0.0 0.0 0 1.000
1 min 0.1 0.3 0 0.025* 0.8 0.6 1 <0.001* <0.001*
3 min 0.5 0.6 0 <0.001* 2.0 0.5 2 <0.001* <0.001*
5 min 1.2 0.7 1 <0.001* 3.0 0.5 3 <0.001* <0.001*
10 min 2.3 0.7 2 <0.001* 3.7 0.5 4 <0.001* <0.001*
15 min 3.4 0.7 4 <0.001* 3.9 0.4 4 <0.001* 0.002*
20 min 3.9 0.7 4 <0.001* 3.9 0.3 4 <0.001* 0.975
25 min 3.9 0.6 4 <0.001* 4.0 0.2 4 <0.001* 0.579
30 min 3.9 0.6 4 <0.001* 4.0 0.2 4 <0.001* 0.986
40 min 3.8 0.7 4 <0.001* 4.0 0.2 4 <0.001* 0.048*
50 min 3.7 0.7 4 <0.001* 4.0 0.0 4 <0.001* 0.006*
1 hr 3.9 0.7 4 <0.001* 3.9 0.4 4 <0.001* 0.317
2 hr 2.9 1.1 3 <0.001* 3.5 0.5 4 <0.001* 0.006*
6 hr 0.0 0.0 0 1.000 0.1 0.3 0 0.046* 0.041*
12 hr 0.0 0.0 0 1.000 0.0 0.0 0 1.000 1.000
24 hr 0.0 0.0 0 1.000 0.0 0.0 0 1.000 1.000
In the study there was significant difference in Modified Bromage Score between two groups from 1 min to 15 min and at 40 min, 50 min, 2 hrs and 6hrs. At other intervals there was no significant difference in median Bromage score.
In Plain Ropivacaine group there was significant difference in Median Modified Bromage Score from 1 min to 2hr compared to baseline. Initially there was increase in Modified Bromage Score and after 2hr Modified Bromage Score started to decrease towards baseline value.
In Hyperbaric Ropivacaine group there was significant difference in Median Modified Bromage Score from 1 min to 6hr compared to baseline. Initially there was increase in Modified Bromage Score and after 2hr Modified Bromage Score started to decrease towards baseline value.

Fig 17: Line diagram showing Modified Bromage Score comparison between two groups at different time intervals
Table 15: Durations comparison between two groups
Group P value
Plain RopivacaineHyperbaric RopivacaineMean SD Mean SD Duration of surgery (min) 90.4 31.3 107.8 61.6 0.115
Onset to T-10 (min) 10.1 1.6 4.6 0.9 <0.001*
Time to Maximum Block (min) 13.0 2.7 8.9 0.9 <0.001*
Duration at T10 (min) 94.7 24.7 146.1 31.9 <0.001*
Sensory Regression (min) 291.6 74.3 239.9 39.8 <0.001*
Motor Regression (min) 225.4 68.4 186.0 41.0 0.003*
Time to mobilise (min) 309.1 76.3 251.0 41.1 <0.001*
In Plain Ropivacaine group, mean duration of surgery was 90.4 ± 31.3 min and in Hyperbaric Ropivacaine group, mean duration of surgery was 107.8 ± 61.6. There was significant difference in mean duration of surgery between two groups.
In Plain Ropivacaine group, mean Onset to T-10 was 10.1 ± 1.6 min and in Hyperbaric Ropivacaine group, mean Onset to T-10 was 4.6 ± 0.9. There was significant difference in mean Onset to T-10 between two groups.
In Plain Ropivacaine group, mean Time to Maximum Block was 13.0 ± 2.7 min and in Hyperbaric Ropivacaine group, mean Time to Maximum Block was 8.9 ± 0.9. There was significant difference in mean Time to Maximum Block between two groups.
In Plain Ropivacaine group, mean Duration at T10 was 94.7 ± 24.7 min and in Hyperbaric Ropivacaine group, mean Duration at T10 was 146.1 ± 31.9. There was significant difference in mean Duration at T10 between two groups.
In Plain Ropivacaine group, mean Duration for Sensory Regression was 291.6 ± 74.3 min and in Hyperbaric Ropivacaine group, mean Duration for Sensory Regression was 239.9 ± 39.8. There was significant difference in mean Duration for Sensory Regression between two groups.
In Plain Ropivacaine group, mean Duration for Motor Regression was 225.4 ± 68.4 min and in Hyperbaric Ropivacaine group, mean Duration for Motor Regression was 186.0 ± 41.0. There was significant difference in mean Duration for Motor Regression between two groups.
In Plain Ropivacaine group, mean Time to mobilise was 309.1 ± 76.3 min and in Hyperbaric Ropivacaine group, mean Time to mobilise was 251.0 ± 41.1. There was significant difference in mean Time to mobilise between two groups.

Fig 18: Bar diagram showing Durations comparison between two groups

Fig 19: Bar diagram showing Onset to T10 and Time to Maximum Block between two groups
Table 16 : Median Maximum Block comparison between two groups
Group
Plain Ropivacaine Hyperbaric
RopivacaineCount % Count %
Median Maximum Block (Dermatome) T4 2 5.0% 26 65.0%
T5 1 2.5% 12 30.0%
T6 25 62.5% 2 5.0%
T7 8 20.0% 0 0.0%
T8 3 7.5% 0 0.0%
T10 1 2.5% 0 0.0%
? 2 = 61.47, df = 5, p <0.001*
In Plain Ropivacaine group, majority of subjects had Median Maximum Block at T6 (62.5%) and in Hyperbaric Ropivacaine majority of subjects had Median Maximum Block at T4 (65%). This difference in Median maximum block between two groups was statistically significant.

Fig 19: Bar diagram showing Median Maximum Block comparison between two groups