COMPARISON OF EFFECTS OF SPINAL ADDITIVESFENTANYL AND CLONIDINE WITH HYPERBARIC BUPIVACCAINE

Dr. V.Philitsen .

MY GUIDE

PROFESSOR Dr. P.S.SHANMUGAM, M.D.,D.AH.O.D. OF ANESTHESIOLOGY KILPAUK MEDICAL COLLEGE

CHENNAI

AIM OF THE STUDY

To compare the effects of intrathecal fentanyl with 0.5% Bupivaccaine(H) and clonidine with 0.5% Bupivaccaine(H) with control group of patients who received only 0.5% Bupivaccaine(H).

STUDY DESIGN

Prospective randomised control study

After Ethical committee approval

Pre – operative assesment done for all cases

Informed consent obtained ,

INCLUSION CRITERIA

ASA PS – 1 & 2 patients

Both male and female patients

Age within 20 and 40 years

Patients who have given consent

Elective surgeries

EXCLUSION CRITERIA

Contraindication for spinal anesthesia

ASA PS 3,4 & 5 patients

Patients who have not given consent

Age more than 40 years and less than 20 years

Drugs Used

-0.5 % Hyperbaric Bupivaccaine

-Preservative free Fentanyl

-Preservative free Clonidine

-0.9 % Normal Saline

GROUPS

A – 15 mg of 0.5% bupivaccaine(H) + 0.5ml of N.S.

B – 15 mg of 0.5% bupivaccaine(H) + 25 µg of Fentanyl

C – 15 mg of 0.5% bupivaccaine(H) + 50 µg of clonidine corrected to a volume of 0.5ml by adding N.S.

STUDY METHODOLOGY

- 45 Patients were assigned to 3 groups 15 each

-No patients were sedated intra operatively.

-After recording pre-operative vitals intra - venous line was started and pre-loaded with 500 ml of Ringer lactate fluid 15 minutes before the time of spinal anesthesia.

-Table was ensured to be horizontal

-Under aseptic precautions SAB was done for all patients in right lateral position and in L3-4 space using a 25 G Quincke - Babcock needle

-Patients who had hypotension were managed with Ephedrine and intra venous fluids

MONITORS

-NIBP (for every 5 min.)

-ECG

-PULSEOXIMETER

-TEMPERATURE

Vital parameters were monitored for every 5 min in the first hour and every 10 min thereafter.

CLINICAL PARAMETERS

Maximum sensory level blocked (Until grade 3)

Time to achieve maximum sensory level

Regression time to L1 (Until grade 0)

Onset of grade 4 motor block

Regression time to grade 1 motor block

Sedation score

ASSESSMENT OF SENSORY BLOCK

Assessment of sensory loss to pain was done by using24 gauge intramuscular needle until the patient had grade 3 Sensory block.

0 - Normal sensation of pin prick

+ - Pin prick felt as sharp pointed but weaker compared with the same

area in other side.

++ - Pin prick felt as touch with blunt object

+++ - No perception of pin prick

HOLLMAN’S SCALE

ASSESMENT OF MOTOR BLOCK

Grade Criteria Degree of Block

I Free movement of legs and feet Nil (0%)

II Just able to flex knees with free movement of feet Partial (33%)

III Unable to flex knees, but with free movement of feet

Almost Complete (66%)

IV Unable to move legs or feet Complete (100%)

BROMAGE SCORE

ASSESMENT OF SEDATION LEVEL

1 - Anxious or agitated or restless

2 – Cooperative ,oriented

3 – Responds only to commands but awake

4 – Asleep and brisk response to commands

5 – Asleep and sluggish response to commands

6 – No response to auditory stimulus

RAMSEY SEDATION SCORE

STATISTICAL ANALYSIS

DEMOGRAPHICDETAILS

AGE

95% Confidence Interval for Mean

N Mean Std. Deviation Std. Error Lower Bound Upper Bound 1 15 31 7.376 1.905 27.78 35.95

2 15 30 5.431 1.402 27.73 33.74

3 15 32 6.338 1.636 29.29 36.31

ANOVA

AGE

Sum of Squares df Mean Square Sig.

Between Groups 32.133 2 16.067 .681Within Groups 1737.067 42 41.359

HEIGHT

95% Confidence Interval for Mean

N Mean Std. Deviation Std. Error Lower Bound Upper Bound 1 15 165.60 6.243 1.612 162.14 169.06

2 15 165.20 6.213 1.604 161.76 168.64

3 15 164.67 5.367 1.386 161.69 167.64

ANOVAHEIGHT

Sum of Squares df Mean Square Sig.

Between Groups 6.578 2 3.289 .912Within Groups 1489.333 42 35.460

WEIGHT

95% Confidence Interval for Mean

N Mean Std. Deviation Std. Error Lower Bound Upper Bound 1 15 70.53 7.549 1.949 66.35 74.71

2 15 69.07 5.934 1.532 65.78 72.35

3 15 70.33 8.191 2.115 65.80 74.87

ANOVA

WEIGHT

Sum of Squares df Mean Square Sig.

Between Groups 18.978 2 9.489 .837Within Groups 2230.000 42 53.095

CLINICALPARAMETERS

MAXIMUM SENSORY LEVEL BLOCKED

95% Confidence Interval for Mean

N Mean Std. Deviation Std. Error Lower Bound Upper Bound1 15 5 1.424 .368 4.41 5.99

2 15 4 .884 .228 4.44 5.42

3 15 5 1.254 .324 4.31 5.69

ANOVAMAXIMUM SENSORY LEVEL BLOCKED

Sum of Squares df Mean Square Sig.

Between Groups .578 2 .289 .821Within Groups 61.333 42 1.460

TIME TO ACHIEVE MAXIMUM SENSORY LEVEL IN MINUTES

95% Confidence Interval for Mean

N Mean Std. Deviation Std. Error Lower Bound Upper Bound1 15 28.33 7.943 2.051 23.93 32.73

2 15 22.80 7.785 2.010 18.49 27.11

3 15 24.20 7.213 1.862 20.21 28.19

TIME TO ACHIEVE MAXIMUM SENSORY LEVEL IN MINUTES

Sum of Squares df Mean Square Sig.

Between Groups 248.311 2 124.156 .133Within Groups 2460.133 42 58.575

SENSORY REGRESSION TO L1 MINUTES

95% Confidence Interval for Mean

N Mean Std. Deviation Std. Error Lower Bound Upper Bound1 15

171.2019.969 5.156 160.14 182.26

2 15231.00

47.442 12.249 204.73 257.27

3 15250.67

35.950 9.282 230.76 270.57

ANOVASENSORY REGRESSION TO L1 MINUTES

Sum of Squares df Mean Square Sig.

Between Groups 51388.844 2 25694.422 .000Within Groups 55185.733 42 1313.946

Multiple Comparisons

SENSORY REGRESSION TO L1 MINUTESLSD

(I) GROUP (J) GROUP

95% Confidence Interval

Mean Difference (I-J) Std. Error Sig. Lower Bound Upper Bound

1 2 -59.800* 13.236 .000 -86.51 -33.09

3 -79.467* 13.236 .000 -106.18 -52.76

2 1 59.800* 13.236 .000 33.09 86.51

3 -19.667 13.236 .145 -46.38 7.04

3 1 79.467* 13.236 .000 52.76 106.18

2 19.667 13.236 .145 -7.04 46.38

Post Hoc Tests

No statistical significance between group 2 and 3 but both groups are significant on comparing to group 1.

ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES

95% Confidence Interval for Mean

N Mean Std. Deviation Std. Error Lower Bound Upper Bound1 15 10.00 2.619 .676 8.55 11.45

2 15 6.87 4.138 1.068 4.58 9.16

3 15 5.73 1.870 .483 4.70 6.77

ANOVA

ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES

Sum of Squares df Mean Square Sig.

Between Groups 146.533 2 73.267 .001Within Groups 384.667 42 9.159

Multiple Comparisons

ONSET OF GRADE 4 MOTOR BLOCK IN MINUTESLSD

(I) GROUP (J) GROUP

95% Confidence Interval

Mean Difference (I-J) Std. Error Sig. Lower Bound Upper Bound

1 2 3.133* 1.105 .007 .90 5.36

3 4.267* 1.105 .000 2.04 6.50

2 1 -3.133* 1.105 .007 -5.36 -.90

3 1.133 1.105 .311 -1.10 3.36

3 1 -4.267* 1.105 .000 -6.50 -2.04

2 -1.133 1.105 .311 -3.36 1.10

*. The mean difference is significant at the 0.05 level.

Post Hoc Tests

No statistical significance between group 2 and 3 but both groups are significant on comparing to group 1.

REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES

95% Confidence Interval for Mean

N Mean Std. Deviation Std. Error Lower Bound Upper Bound1 15 188.67 20.999 5.422 177.04 200.30

2 15 234.20 31.412 8.111 216.80 251.60

3 15 273.00 26.979 6.966 258.06 287.94

ANOVA

REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES

Sum of Squares df Mean Square Sig.

Between Groups 53454.178 2 26727.089 .000Within Groups 30177.733 42 718.517

Multiple Comparisons

REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTESLSD

(I) GROUP (J) GROUP

95% Confidence Interval

Mean Difference (I-J) Std. Error Sig. Lower Bound Upper Bound

1 2 -45.533* 9.788 .000 -65.29 -25.78

3 -84.333* 9.788 .000 -104.09 -64.58

2 1 45.533* 9.788 .000 25.78 65.29

3 -38.800* 9.788 .000 -58.55 -19.05

3 1 84.333* 9.788 .000 64.58 104.09

2 38.800* 9.788 .000 19.05 58.55

Post Hoc Tests

HEMODYNAMIC VARIABLES

Descriptives

N Mean Std. Deviation Std. Error SYSTOLIC 1 15 102.93 10.872 2.807

2 15 98.00 6.928 1.789

3 15 91.47 8.052 2.079

DIASTOLIC 1 15 58.00 7.635 1.971

2 15 55.60 10.802 2.789

3 15 47.20 6.625 1.710

ANOVA

F Sig.MINIMUM BP SYSTOLIC Between Groups 6.444 .004MINIMUM BP DIASTOLIC Between Groups 6.613 .003

BP AT 15 MIN

Descriptives

N Mean Std. Deviation Std. Error SYSTOLIC 1 15 113.67 10.795 2.787

2 15 107.20 6.201 1.601

3 15 102.33 5.150 1.330

DIASTOLIC 1 15 67.20 7.183 1.855

2 15 65.00 7.241 1.870

3 15 58.80 4.212 1.088

ANOVA

F Sig.MEAN BP SYSTOLIC Between Groups 8.014 .001MEAN BP DIASTOLIC Between Groups 7.011 .002

BP AT 30 MIN

Descriptives

BP AT 60 MIN

N Mean Std. Deviation Std. Error SYSTOLIC 1 15 108.56 10.795 2.787

2 15 100.20 6.201 1.601

3 15 96.33 5.150 1.330

DIASTOLIC 1 15 68.20 7.183 1.855

2 15 65.00 7.241 1.870

3 15 52.40 4.212 1.088

ANOVA

F Sig.MINIMUM BP SYSTOLIC Between Groups 6.444 .066MINIMUM BP DIASTOLIC Between Groups 6.613 .002

Descriptives

HEART RATE N Mean Std. Deviation Std. Error

At 15 min.1 15 77.07 9.823 2.536

2 15 73.13 8.123 2.097

3 15 64.47 7.210 1.862

At 30 min.1 15 89.07 9.354 2.415

2 15 73.87 11.438 2.953

3 15 70.80 8.833 2.281

HEART RATE N Mean Std. Deviation Std. Error

At 60 min.1 15 85.01 12.823 2.536

2 15 84.13 9.123 2.097

3 15 71.36 5.210 1.862

HEART RATE SIGNIFICANCE15 MIN 0.00130 MIN 0.00060 MIN 0.004

ANOVA

RAMSEY SEDATION SCORE

Score GROUP

1 2 3 1

15

3 0

2

11 0

3 1 7

4 0 8

Total Count 15

15 15P= 0.000 SIGNIFICANT.

GROUP 1 2 315

3

11

1

87

RESULTS

- Onset of grade 4 motor block was shorter in group 2 and 3 with an average of around 5 to 7 minutes.

-Regression to grade 1 motor block is significantly prolonged in group 3 and 2 but group 3 is longer than 2.

-Sensory regression to L1 is prolonged in the additive groups but not significantly prolonged while comparing these two groups.

-Maximum height of dermatomal block was not significant in all these groups and the time to achieve it was also not significant.

-Hemodynamic variables were relatively lower in clonidine group.

-All the patients in clonidine group were well sedated.

CONCLUSIONCLONIDINE when used as a spinal additive to hyperbaric bupivaccaine

In healthy adults it prolongs the duration of spinal anesthesia but with a

hemodynamic variation which can be easily managed

while comparing with fentanyl which also prolongs the spinal

Anesthesia with not of much variation in the hemodynamic variables.

Clonidine has an additional advantage of sedating the patient.

THANK YOU.

REFERENCES

•Chavda et al Internet Journal of Anesthesia ‘09.

•Mary Samuel et al IJA ‘07.

•Stephan Strebe et al Anesth.Analg.’04.

•Biswas et al IJA ‘02