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临床试验/CTRI/2017/10/010209
CTRI/2017/10/010209已完成不适用

Comparison of isobaric levobupivacaine versus hyperbaric bupivacaine in spinal anesthesia for cesarean section: A prospective unmatched case control study

Pannadhai Zanana Hospital attached to RNT medical college1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年11月3日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Success rate ( number of cases in whom surgery could be completed without supplementation )

研究概览

简要总结

Bothgroups were comparable regarding age, ASA grade, duration of surgery andpreoperative vital parameters

Sensory Motor Block characteristics:Sensory onset was significantly faster with hyperbaric bupivacaine as comparedto isobaric levobupivacaine, as shown by difference in time to T8 (3.12±0.86min in group L, 2.8 ±0.74 min in group B, p = 0.048) and time to T6(4.28±1.04 min in group L, 3.8±0.81 min in group B, p = 0.011) though thisdifference of less than 1 min was clinically not significant.     All patients of both groups achieved targetsensory level of T6 which was necessary to start caesarean sectionin spinal anaesthesia. Peak sensory level at 10 min ranged from T3-T6in both groups however  median value wasT6 in group L as compared to T4 in group B. Mean value ofpeak sensory level was comparable in two groups (T4.74±1.03 in groupB and T5.12±0.97in group L, p =0.060). The time to reach peaksensory level was also statistically comparable in two groups (4.68±0.81 min ingroup L, 4.44±0.63 min in group B, p = 0.095).

Allpatients of both groups achieved maximum Bromage score of 3, signifyingcomplete motor block. Motor onset in terms of time to achieve maximum Bromageof 3 was significantly faster with hyperbaric bupivacaine (3.04±0.69 min ingroup B) as compared to isobaric levobupivacaine (3.56±0.63 min in group L),p=0.0002, however this difference of less than 1 min was clinically notsignificant.

Durationof analgesia (time to first rescue analgesia)was significantly longer in group B (155.7±14.35 min) as compared to group L(140.3±12.74 min), p=0.0001. Sensory block duration was significantlylonger in group B (210.7±22.18 min) as compared to group L (186.0±21.26 min), p= 0.0001. Motor block duration was significantly longer in group B(250.9±24.20 min) as compared to group L (223.9±23.11 min), p = 0.0001

 **Haemodynamic Parameters:**There was no significant difference in mean value of systolic BP, diastolic BP,pulse rate and SpO2 in both groups throughout the study period(p>0.05).

**Adverse effects:**Occurrence of hypotension was comparatively more in group B, [36% (n=18)] ascompared to group L [28% (n=14)], p > 0.05. Perioperative nausea andvomiting was also more in group B (8%, n =4) than in group L (4%, n =2), p >0.05. No neonatal and maternal complications or any other adverse effects wereobserved.

Success rate (clinical efficacy) of spinal block**:**Incidence of “completely successful†spinal block (no supplementation) was 100%(n=50) in both the groups. None of the patient in both groups requiredanaesthetic supplementation or general anaesthesia. Both 12.5 mg isobaric levobupivacaine and 10 mg hyperbaricbupivacaine in spinal anaesthesia were graded as “perfect agent†for CS, owingto 100% complete success rate in both groups.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 30.00 Year(s)(—)
性别
Female

入选标准

  • 1.ASA I,II Healthy parturients advised to undergo elective and semi elective cesarean sections for indications 2.previous CS 3.Breech, 4.Cephalopelvic disproportion 5.Pregnancy following infertility treatment, 6.Postdatism, 7.Cord around neck 8.Non-progress of labour.

排除标准

  • 1.Allergy to amide Local anesthetic 2.Any associated systemic illness having cardiovascular, neurological, renal, pulmonary, autoimmune, psychiatric, end stage liver disease etc.) 3.Any coagulation abnormality.
  • 4.Morbid obesity 5.Short stature.
  • 6.Having fetal anomaly 7.Any contraindication to spinal anaesthesia.

结局指标

主要结局

Success rate ( number of cases in whom surgery could be completed without supplementation )

时间窗: Outcome of the study will be observed after the end of surgery and patients recover to preoperative condition.

次要结局

  • (1)Sensory block characteristics ( time to onset , peak sensory level , and duration)((2)Motor block characteristics (time to onset, maximum motor block , and duration))

研究者

发起方
Pannadhai Zanana Hospital attached to RNT medical college
申办方类型
Government medical college

研究点 (1)

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