THE EFFICACY OF INTRATHECAL OF LEVOBUPIVACAINE AND ROPIVACAINE ON LOWER-LIMB SURGERY Dr Lê Ngọc Anh Thy Dr Lưu Kính Khương

BACKGROUND Spinal anesthesia is a regional anesthesia technique which is simple and easy to perform and contribute to the success of the lower limbs surgery. In Viet Nam, levobupivacaine and ropivvacaine have been used for spinal anesthesia for a short time. We have not had much experiences on its efficacy and safety

OBJECTIVES Compare the onset time of sensory block of levobupivacaine and ropivacaine in patients undergoing spinal anesthesia for lower limb surgeries. Compare the onset time of motor block of levobupivacaine and ropivacaine in patients undergoing spinal anesthesia for lower limb surgeries

SUBJECTS - METHOD Method: Randomized controlled clinical trials Subjects: Patients, with ages from 18 to 60, have lower limb surgeries in 115 People Hospital - HCM City, from Jan 2016 to April 2016

SAMPLES n = (Z1 - β + Z 1 - α/2)2(σ12 + σ22 ) (µ1 - µ2)2 In study of Belgin Akan et al, and in study of E. Marret et al: mean time of sensory block µ1 = 19 mins ( σ1 = 4,5) - group L; µ2 = 7 mins (σ2 = 13,5) - group R; α = 0,05, Z 1-α/2 = 1,96; β = 0,2 -> Z1 - β = 0,84. N = 11. We have 25 patients with each group, totally we have 50 patients attending to our study.

SAMPLE SELECTION CRITEIA Patients, indicated with lower limb surgery and agreed to participate in our study. Age: 18- 60 Mental perception is normal (Glassgow scores = 15) ASA: I, II

Exclusion criteria Without the consence from the patient Allergic with Levobupivacaine or Ropivacaine. Severe cardiovascular disease: arterial hypertension uncontrolled, severe heart failure (ejection fraction < 35%). Patients with pathologic coagulopathy. Infections on the skin which is for spinal anesthesia procedure . Patients with abnormal deformities of the spine. Patients with the syndrome of increased intracranial pressure. Alcoholism, or other substance. Pregnancy.

Means of collecting data Documents of patients Monitor tracks: ECG, pulse, BP, SpO2. Spinal anesthetic medication: Levobupivacaine 0,5% and Ropivacaine 0.5% The collected data recorded on the data collection form.

Methods of implementation: In operation room Check the medical records and the routine procedure: name, age and test laboratory abnormalities of patient. The cases were randomly devided into 2 groups of 25 patients in it: group L received Levobupivacaine, group R received Ropivacaine.

Spinal anesthesia procedure Catheter for spinal anesthesia: 25G. Position: L4 - L5. Group R: Ropivacaine 0,5% 14mg + 2mcg Sufentanil Group L: Levobupivacine 0,5% 14mg + 2mcg Sufentanil After reaching sensory block as D10, if patient feels anxious: midazolam 0.5 - 1 mg, 2-liter oxygen / minute via nasal cannula

SOME DEFINITIONS Assessing the impact on circulation Heart rate: monitoring ECG DII - lead. If the heart rate ≤ 50 times / minute, we call it bradycardia -> use atropine Blood pressure: monotoring the systolic blood pressure, the diastolic blood pressure, the mean arterial pressure (MAP). We compare the level of MAP at the time before and after we do spinal anesthesia. If it decreases 20% lower than the level at the time before the spinal anesthesia is done, we consider it as a low blood pressure and treated with ephedrine.

SOME DEFINITIONS Assessing the impact on the respiratory system: - Monitoring the respiratory rate and SpO2. - Respiratory failure means the respiratory rate < 10 beats / minute and SpO2 < 90%. Depending on the degree possible by face mask management, ventilation Endotracheal intubation or mechanical ventilation.

COMPLICATION MANAGEMENT Slow BP: rapid infusion, if not improve, use ephedrine: 3mg, IV Slow respiratoty rate < 50 l/p: use atropin 0,5mg, IV SpO2 < 90%: O2 6 litres/min through a mask , if SpO2 keeps falling < 90% → respiratory failure and patient will be intubated. 30 minutes after being done with spinal anesthesia but patient can not have D10 sensory block → change another anesthesia procedure.

Data collection Assessing the sensory block time: The time from the moment completing the spinal anesthetic procedure to the moment the patient has sensory block as D10. We use a blunt needle to check pain feeling every 2 minutes during the first 30 minutes after anesthesia. Acording to D.B.Scott: D12: loss of feeling pain from the inguinal fold below. D10: loss of feeling pain from the navel below. D6: loss of feeling pain from xiphoid process below.

Data collection Assess inhibition of movement according to Bromage improved transcripts Degree 0: Complete movement. Degree 1: Unable to raise stretched leg, able to flex knee. Degree 2: Unable to flex knee and able to flex ankle. Degree 3: No movement

Date colection Assesing the efficacy of pain relief for surgery: Arcording to Abouleizh Ezzat Good: the patient completely painless. Average: mild pain, but patient needs to be used sufentanil 5-10 mcg. Poor: patient feels pain, and need to use another method of anesthesia (failure of spinal anesthesia).

Data collection The index of respiratory and circulation will be recorded: - Before spinal anesthesia procedure - After spinal anesthesia procedure: every 5 minutes in the first 30 minutes, then every 10 minutes until the end of surgery.

Data collection Assessing some undesired effects: Nausea Shivering. Vomit Nausea Shivering. Pruritus. Headache.

Data collection Handling results: - Statistical SPSS - Comparison of quantitative variables according to the T test - For all cases, significance level was established to 5% (p < 0,05) .

RESULTS Demographics data Group L (N=25) Group R (N=25) P Male/Female Age Weight Height BMI 48%/ 52% 45,2 ± 18,1 59,8 ± 7,9 159,9 ± 4,9 22,7 ± 2,6 44% / 56% 43 ± 11,9 58,6 ± 7,6 157,9 ± 5,5 23,3 ± 2,2 0,77 0,62 0,56 0,18 0,35 ASA I II Diseases -Hypertension -Without disease 9 (36%) 16 (64%) 2 (8%) 23 (92%) 5 (64) 20 (80) 5 (20%) 20 (80%) 0,2 0,38 Hai nhóm BN có độ phân bố tuổi, giới tính, cân nặng, chiều cao, BMI, phân loại ASA, bệnh lý đi kèm, và thời gian phẫu thuật tương đối đồng đều. Trong đó, chủ yếu là ASA I, II và bệnh lý đi kèm là tăng HA.

The efficacy of spinal anesthesia betwwen 2 groups RESULTS The efficacy of spinal anesthesia betwwen 2 groups Group R Group L P Time - D12 sensory block (mins) 4,8 ± 3,1 7,2 ± 3,6 0,017* Time - D10 sensory block (mins) 8,2 ± 4,3 12,8 ± 5,5 0,002* Time - motor block (mins) at level 3 of Bromage (mins) 15,7 ± 6,4 16,6 ± 4,6 0,58 Hai nhóm không có sự khác biệt có ý nghĩa thống kê về: mức phong bế cảm giác cao nhất, thời gian ức chế vận động. Hai nhóm lại có sự khác biệt có ý nghĩa về thời gian phong bế cảm giác mức T12 và T10

DISCUSSION Assesing the efficacy of pain relief for surgery - In our study, the efficacy of pain relief of both 2 groups are good, no cases are average or poor. - In study of Breebaart MB et al, the efficacy of pain relief also achieve 100%, the same with us.

DISCUSSION Time - Sensory Block Group R Group L P Time - sensory block as D12 level (mins) 4,8 ± 3,12 7,16 ± 3,6 0,017* Time - sensory block as D10 level (mins) 8,24 ± 4,28 12,84 ± 5,53 0,002* - In study of Breebaart MB et al, time - sensory block in goup R (dose15mg) is 7 ± 4 mins, in group L (dose 10mg) is 8 ± 6 mins. - In study of Afonso Claudio et al, they used Ropivacine with dose 20mg, time - sensory block in goup R is 2,9 ± 1,27 mins. - In different studies, they used different doses of Ropivacaine or Levobupivaciane, so the Time of sensory block as D10 level have a wide ranges. Có sự khác biệt có ý nghĩa giữa 2 nhóm trong thời gian để mất cảm giác đau từ nếp bẹn trở xuống (D12) và thời gian để mất cảm giác đau từ ngang rốn trở xuống (D10)

DISCUSSION Time - Motor Block Group R Group L P Time - motor block at level 1 (mins) 8,72 ± 4,38 16,2 ± 21,98 0,10 Time - motor block at level 2 (mins) 12,24 ± 6,15 12,48 ± 4,82 0,88 Time - motor block at level 3 (mins) 15,68 ± 6,37 16,56 ± 4,6 0,58 - There is no significant differences of time of motor block between 2 groups. - In study of Afonso Claudio et al, they used Ropivacine with higher dose (20mg), time of motor block in group R is 6,2 ± 3,58 mins.

DISCUSSION Assessing the change of Heart rate Heart rate Group R Group L P T0 → T15 > 0,05 T15 79,84 ± 12,21 73,00 ± 11,23 0,045* T20 79,2 ± 12,08 72,32 ± 11,01 0,041* T25 76,2 ± 10,55 69,08 ± 10,17 0,019* T30 74,76 ± 9,37 68,44 ± 9,53 0,022* T35 beyone Group R Group L Total Slow heart rate 2 (92%) 4 Without slow heart rate 23 (8%) 46 25 50 P > 0,05

DISCUSSION Assessing the changing in Heart rate - There is no significant differences in the rate of slow heart rate between 2 groups. - However, at the moment of 15th, 20th, 25th and 30th minutes, there are significant differences in the rate of slow heart rate between 2 groups (p < 0,05). The heart rate in group L is lower than the one in group R.

Systolic Blood Pressure Diastolic Blood Pressure DISCUSSION Assessing the change of Blood Pressure Systolic Blood Pressure Group R Group L Total Low SBP (%) 4 (16) 7 (28) 11 Without low SBP (%) 21 (84) 18 (72) 39 25 50 P > 0,05 Mean Blood Pressure Low MBP (%) 8 (32) 5 (20) 13 Without low MBP (%) 17 (68) 20 (80) 37 Total 25 50 P > 0,05 Diastolic Blood Pressure Low DBP (%) 8 (32) 5 (20) 13 Without low DBP (%) 17 (68) 20 (80) 37 Total 25 50 P > 0,05

DISCUSSION Assessing the change of Blood Pressure - With SBP, MBP, and DBP, there are no significant differences between 2 groups (P > 0,05) - In the study of Gianluca et al: there are no significant differences in the rate of low blood pressure or slow heart rate between 2 group: group R (dose 7,5mg) and group L (dose 7,5mg)

DISCUSSION Side effects Group R Group L Total Without side effects 22 (88) 21 (84) 43 Nausea (%) Vomit (%) 2 (8) 2 Shivering (%) 3 (12) 5 Headache (%) Spiritus (%) 25 50 - Group R have 3 patients (12%) and group L have 2 patients (8%) getting shivering. Group L have 2 patients (8%) getting vomit, but group E have no cases. However, there is no significant differences between 2 groups. - This results is the same in the study of Gianluca et al, and in the study of Breebaart MB et al.

CONCLUSION The efficacy of pain relief of Ropivacaine and Levobupivacaine are good. The dose of 14 mg Ropivacaine 0,5% + 2 mcg sufentanil has faster efficacy of sensory block but the same efficacy of motor block compared with the dose of 14 mg Levobupivacaine + 2 mcg sufentanil. At the moment of 15th, 20th, 25th and 30th minutes, there are significant differences in the rate of slow heart rate between 2 groups (p < 0,05). The heart rate in group L is lower than the one in group R.

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