RESULTSIt 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 GroupPlain RopivacaineHyperbaric RopivacaineCount % Count %Gender Female 20 50.
0% 20 50.0% Male 20 50.0% 20 50.
0%? 2 = 0.001, df = 1, p = 1.000In 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 groupsTable 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 SEWeight 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 groupsTable 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 = 0.068In 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 groupsTable 9 : Heart rate comparison between two groups at different time intervalsHR 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 0.4731 min 79.5 8.3 0.
934 80.2 5.7 0.
077 0.6963 min 79.6 8.2 0.855 79.6 5.6 0.
022* 0.9755 min 79.9 8.6 0.446 79.2 5.5 0.
005* 0.67510 min 79.9 8.
3 0.496 79.6 5.8 0.064 0.84015 min 79.3 7.
9 0.604 78.9 6.1 0.009* 0.
81320 min 79.5 7.6 1.
000 78.9 5.3 0.007* 0.
65725 min 79.1 7.3 0.458 78.8 5.2 0.007* 0.82030 min 79.
3 7.4 0.648 78.8 5.0 0.007* 0.75240 min 78.
6 7.0 0.108 79.3 5.1 0.
056 0.63750 min 78.8 7.1 0.176 79.3 4.9 0.
035* 0.7291 hr 78.5 7.3 0.044* 78.6 5.
6 0.001* 0.9322hr 78.
3 7.4 0.020* 79.0 6.
1 0.011* 0.6686 hr 78.5 7.4 0.
033* 78.8 6.1 0.008* 0.83112 hr 78.6 7.
1 0.079 78.5 5.4 0.005* 0.
94424 hr 78.3 7.0 0.029* 78.6 5.0 0.
003* 0.840In 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 intervalsTable 10 : SBP comparison between two groups at different time intervalsSBP 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.
7441 min 120.6 12.4 0.016* 121.5 13.5 0.611 0.7443 min 119.
7 12.2 0.002* 119.
4 13.8 0.721 0.9125 min 117.
5 11.9 <0.001* 117.0 13.7 0.209 0.
86910 min 115.6 11.5 <0.001* 115.1 13.1 0.
056 0.88515 min 113.6 11.4 <0.001* 113.
3 13.2 0.011* 0.
89220 min 112.2 11.5 <0.001* 111.6 13.1 0.
002* 0.82825 min 110.7 11.5 <0.001* 111.6 12.9 0.
002* 0.74330 min 110.4 11.
1 <0.001* 112.1 12.6 0.004* 0.
51240 min 110.6 10.9 <0.001* 112.8 12.8 0.
007* 0.42150 min 111.2 11.7 <0.001* 114.2 13.1 0.
027* 0.2921 hr 111.5 11.2 <0.001* 115.1 13.1 0.058 0.
1952 hr 113.9 11.4 <0.001* 116.1 13.0 0.
140 0.4036hr 115.5 10.9 <0.001* 117.4 13.
5 0.284 0.50712 hr 116.4 11.4 <0.
001* 119.3 12.8 0.710 0.29624 hr 117.0 10.9 <0.001* 119.
7 13.4 0.850 0.321In 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 intervalsTable 11: DBP comparison between two groups at different time intervals DBP Group P value b/w two groupsPlain RopivacaineHyperbaric RopivacaineMean SD P value within the group Mean SD P value within the group Baseline 77.8 7.3 81.2 8.
6 0.0601 min 78.0 8.3 0.557 80.2 8.8 <0.001* 0.
2693 min 77.0 8.0 0.111 78.8 8.7 <0.001* 0.
3535 min 75.0 7.2 <0.001* 77.1 8.
9 <0.001* 0.22710 min 74.1 7.3 <0.
001* 75.4 8.8 <0.001* 0.
44915 min 72.3 6.8 <0.001* 73.9 8.9 <0.001* 0.
38520 min 70.9 7.1 <0.
001* 73.1 8.9 <0.001* 0.23825 min 69.8 6.9 <0.001* 72.
7 8.4 0.002* 0.09130 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 intervalsTable 12 : MAP comparison between two groups at different time intervalsMAP 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.
1711 min 91.4 9.0 0.725 93.
2 9.6 <0.001* 0.3973 min 90.
9 9.1 0.711 91.8 9.6 <0.001* 0.6685 min 88.
9 8.4 0.006* 90.0 9.9 <0.001* 0.60210 min 87.
8 8.3 <0.001* 88.5 10.0 <0.
001* 0.73415 min 85.9 8.0 <0.001* 86.
5 9.5 <0.001* 0.76120 min 84.5 8.2 <0.
001* 85.5 9.7 <0.001* 0.62925 min 83.3 8.0 <0.
001* 85.2 9.3 <0.001* 0.31830 min 82.5 8.1 <0.001* 85.
4 9.0 <0.001* 0.13340 min 83.2 7.7 <0.001* 86.
1 9.1 <0.001* 0.13450 min 84.
3 8.2 <0.001* 86.9 9.1 <0.001* 0.
1911 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* 0.0826 hr 86.7 8.1 <0.001* 89.7 9.2 <0.001* 0.12312 hr 87.3 7.8 <0.001* 91.0 9.2 <0.001* 0.05724 hr 88.3 7.8 0.004* 91.5 9.3 <0.001* 0.099In 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 intervalsTable 13 : SpO2 comparison between two groups at different time intervalsSpO2 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 0.2201 min 99.8 0.5 0.038* 99.7 0.5 0.352 0.8243 min 99.8 0.4 0.038* 99.8 0.4 0.135 0.7965 min 99.9 0.3 <0.001* 99.8 0.5 0.281 0.05210 min 99.8 0.4 0.009* 99.9 0.3 0.006* 0.21515 min 99.8 0.4 0.014* 99.8 0.4 0.058 0.77820 min 99.9 0.3 0.002* 99.7 0.4 0.230 0.14025 min 99.9 0.3 0.002* 99.9 0.3 0.006 1.00030 min 99.8 0.4 0.004* 99.9 0.3 0.003* 0.33640 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* 0.4101 hr 99.8 0.5 0.022* 99.8 0.4 0.281 0.8192 hr 99.6 0.6 0.418 99.7 0.6 0.352 0.2646 hr 99.5 0.7 0.637 99.6 0.6 0.643 0.73512 hr 99.5 0.6 0.860 99.5 0.8 0.309 1.00024 hr 99.1 0.8 0.02* 99.2 0.7 0.012* 0.394In 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 intervalsTable 14 : Modified Bromage Score comparison between two groups at different time intervalsMBS 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 1.0001 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* 0.97525 min 3.9 0.6 4 <0.001* 4.0 0.2 4 <0.001* 0.57930 min 3.9 0.6 4 <0.001* 4.0 0.2 4 <0.001* 0.98640 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* 0.3172 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 1.00024 hr 0.0 0.0 0 1.000 0.0 0.0 0 1.000 1.000In 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 intervalsTable 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 0.115Onset 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 groupsFig 19: Bar diagram showing Onset to T10 and Time to Maximum Block between two groupsTable 16 : Median Maximum Block comparison between two groups GroupPlain 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
