Segmental Spinal Anaesthesia Comparing Isobaric Levobupivacaine Versus Isobaric Ropivacaine For Abdominal Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To compare the efficacy of isobaric levobupivacaine with isobaric ropivacaine in abdominal
研究概览
简要总结
After obtaining ethical committee approval and obtaining written and informed consent, patients
of ASA I to III (American society of anesthesia) physical status who are undergoing elective major and minor
abdominal surgeries under segmental spinal anaesthesia will be recruited to participate in the study. It is a
double blind randomized control trial study. Total 64 patients, 32 in each group will be randomized into Group
L- to receive 2 ml of isobaric levobupivacaine (0.5%) with 25 mcg of fentanyl and Group R- to receive 2 ml of
isobaric ropivacaine (0.5%) with 25 mcg of fentanyl using winpepi software.
Pre anesthetic check up will be carried out in all patients with detailed history, general and systemic
examination and investigations. Informed written consent will be taken from patients after explaining all
benefits and risks of the procedure. After checking the adequate hours of nil by mouth, arrival to the pre￾operative room temperature, heart rate, respiratory rate, blood pressure and spo2 will be recorded in all
patients, an intravenous line will be secured and patients will be preloaded with iv fluids half an hour before
anaesthesia according to patient profile. All patients in both group will be given i.v ranitidine and ondansetron.
All patients in both group will be given inj.Midazolam 0.02mg/kg i.v prior to surgery.
In both Group-L and Group-R, the patients will be placed in sitting position, under all aseptic
precautions skin and subcutaneous tissue will be infiltered with 2ml of 2% lignocaine. 23 G/25 G Quincke’s
spinal needle will be inserted. After confirmation of needle tip in the subarachnoid space by free flow of
cerebrospinal fluid, spinal anaesthesia will be given with 2 ml of isobaric levobupivacaine (0.5%) with 25 mcg of
fentanyl in Group-L and 2 ml of isobaric ropivacaine (0.5%) with 25 mcg of fentanyl in Group-R in T7-T8/T8-T9
space through a midline/paramedian approach. Our goal is to achieve the blockade from T4 to L2 dermatome
level. After injection, patients will be placed in supine position immediately. Sensory effect will be assessed by
pin prick method every 2 minutes for first 10 minutes, every 5 minutess till 30 minutes and every 15 minutes till
completion of surgery. Motor effect will be assessed by Modified Bromage scale
Bromage Grading Effect
Grade 0 no motor block & able to flex hips,knees and ankles
Grade 1 just able to flex knees but unable to flex legs
Grade 2 able to move ankles but unable to flex knees
Grade 3 unable to flex ankles, knees or hips, complete motor block
Modiefied Bromage Scale will be assessed every 2 minutes for first 10 minutes, every 5 minutess till 30 minutes
and every 15 minutes till completion of surgery.
Using a preformed structured proforma the following parameters will be recorded: onset of sensory blockade,
onset of motor blockade (Bromage scale 1), maximum dermatomal level of sensory blockade achieved and the
time to achieve it, two segment sensory regression time, maximum grade of motor blockade attained and the
time to achieve it, total duration of analgesia (time to regression to L1) and the duration of motor blockade
(regression to bromage 0). Other parameters such as total duration of surgery, total intraoperative fluid given,
hemodynamic monitoring till the full recovery of sensory and motor blockade will be noted. Patients will be
also monitored for any adverse effects like bradycardia, hypotension, nausea, vomiting, headache, shoulder
pain, pruritus, urinary retention and any hypersensitivity reactions to drug.[4] Hypotension (SBP<90mmhg or
30%fall in SBP from baseline value) will be treated with rapid i.v fluid boluses and if needed
sympathomimetic drugs will be given. Bradycardia (HR<60bpm) will be treated with inj. Atropin 0.6mg iv. In
case of failure of analgesia and anaesthesia, we have back up of general anaesthesia in all cases.
In PACU, patients will be monitored post operatively for 1 hour in view of temperature, pulse,
respiratory rate, blood pressure, spo2. In the post operative period, iv fluid and analgesia will be given
according to standard protocol of an institute.
After completion of surgery, time will be noted till regression of Sensory effect at L2 level is achieved. This will
indicate the end of analgesic effect of drug given.
Surgeon will be asked about their satisfaction for depth of anaesthesia achieved during surgery.
Based on their experience, they will be asked to rate their level of satisfaction using the Likert 5 point
satisfaction scale￾Rating Satisfaction
5 Totally satisfied
4 Satisfied
3 Not satisfied
2 Unsatisfied
1 Totally unsatisfied
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of ASA I to ASA III (American society of anaesthesia) physical status 2) Age >18yrs of either sex 3) Patients undergoing major and minor abdominal surgeries.
排除标准
- •Patients refusal for segmental spinal anaesthesia 2) Infection at site of spinal needle insertion 3) Patients having allergy to local anesthetic drug 4) Coagulopathy or bleeding disorder 5) Increased intracranial pressure 6) Any other relative contraindications of segmental spinal anesthesia.
结局指标
主要结局
To compare the efficacy of isobaric levobupivacaine with isobaric ropivacaine in abdominal
时间窗: Sensory, motor and vitals assessment every 2 minutes for first 10 minutes, every 5 minutess till 30 minutes and every 15 minutes till | completion of surgery
surgeries under segmental spinal anaesthesia
时间窗: Sensory, motor and vitals assessment every 2 minutes for first 10 minutes, every 5 minutess till 30 minutes and every 15 minutes till | completion of surgery
次要结局
- -To assess onset and duration of sensory block, motor block and duration of analgesia by(isobaric solutions of levobupivacaine and ropivacaine with addition of fentanyl)
