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临床试验/CTRI/2025/07/090268
CTRI/2025/07/090268招募中4 期

Comparison of Bupivacaine Heavy 0.5 percent Levobupivacaine Heavy 0.5 percent And Ropivacaine Heavy 0.75 percent in Subarachnoid block (SAB) in lower limb and abdominal surgeries: An Open, Comparative and Randamised Study.

T.N.M.C. and B.Y.L. Charitable Hospital.1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年7月31日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
To compare the subarachnoid block (SAB) characteristics after administration of:

研究概览

简要总结

“Comparison of Efficacy of Equipotent Bupivacaine Heavy 0.5%, Levobupivacaine Heavy 0.5% and Ropivacaine Heavy 0.75% in Subarachnoid Block (SAB): An Open, Comparative and Randomized Study”

Objective:

To compare the efficacy and safety of three local anesthetics — Bupivacaine (0.5%), Levobupivacaine (0.5%), and Ropivacaine (0.75%) — when used for subarachnoid block (spinal anesthesia) in lower limb and abdominal surgeries.

Primary Parameters:

Onset of sensory and motor block

Maximum sensory level attained

Duration of motor and sensory block

Secondary Parameters:

Hemodynamic changes (e.g., hypotension, bradycardia)

Side effects

Tertiary Parameter:

Duration of postoperative analgesia

Recruitment Details:

Study Population:

ASA Grade I–III patients (with well-controlled comorbidities)

Age: 18–75 years

Undergoing lower limb or lower abdominal surgeries

Both male and female participants

Exclusion Criteria Include:

Upper abdominal surgeries

Patients on LMWH/heparin

Severe cardiac conditions (e.g., aortic stenosis)

Neurological disorders (e.g., MS)

Allergy to any study drugs

Spinal deformities

Sample Size:

30 patients per group, totaling 90 participants

Randomization done using computer-generated numbers

Methodology in Brief:

Participants divided into 3 groups:

Group A: Bupivacaine 0.5%

Group B: Levobupivacaine 0.5%

Group C: Ropivacaine 0.75%

Each patient receives 3 mL of the assigned drug intrathecally.

Sensory and motor block assessed at intervals using:

Pinprick/temperature test for sensory block

Modified Bromage Scale for motor block

Hemodynamic parameters and side effects monitored.

Postoperative pain assessed using Visual Analog Scale (VAS).

Statistical Analysis:

PSPP software

ANOVA, Chi-square, Mann-Whitney U, and t-tests

Significance level set at p < 0.05

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • After obtaining consent for SAB 1) American Society of Anesthesiologist grade I ,II and III well controlled Hypertension/DM and any other cardiac conditions which is not contraindicated for SAB 2) Age between 18 to 75 yrs 3) Patient of either sex 4) Undergoing lower limb and lower abdominal surgery.

排除标准

  • Upper abdominal surgeries (Incision extend above the umbilicus) and Lower segment cesarean section.
  • Pt on LMWH and heparin therapy.
  • Fixed cardiac output disorders like Hypertrophic cardiomyopathy,Mital stenosis and Aortic stenosis.
  • Pre-existing neurological conditions which are waxing and waning in nature like multiple sclerosis, poliomyelitis.
  • Allergic to any components of drug or its complications.
  • Any deformity of spine which can affect the natural spread of drug.

结局指标

主要结局

To compare the subarachnoid block (SAB) characteristics after administration of:

时间窗: Block characteristics will be assessed on 0,5,10,15,20,35,60,90 minutes

1)Bupivacaine Heavy 0.5%

时间窗: Block characteristics will be assessed on 0,5,10,15,20,35,60,90 minutes

2)Levobupivacaine Heavy 0.5%

时间窗: Block characteristics will be assessed on 0,5,10,15,20,35,60,90 minutes

3)Ropivacaine Heavy 0.75%

时间窗: Block characteristics will be assessed on 0,5,10,15,20,35,60,90 minutes

Specifically, the primary objectives are:

时间窗: Block characteristics will be assessed on 0,5,10,15,20,35,60,90 minutes

1. Time taken to achieve sensory blockade up to T10 dermatome.

时间窗: Block characteristics will be assessed on 0,5,10,15,20,35,60,90 minutes

2. Time to onset of motor blockade.

时间窗: Block characteristics will be assessed on 0,5,10,15,20,35,60,90 minutes

3. Maximum level of block achieved.

时间窗: Block characteristics will be assessed on 0,5,10,15,20,35,60,90 minutes

4. Duration of sensory and motor blockade.

时间窗: Block characteristics will be assessed on 0,5,10,15,20,35,60,90 minutes

次要结局

  • Hemodynamic change(Monitoring of blood pressure systolic blood pressure and diastolic blood pressure at 5,10,15,30 ,60 and 90 minutes)

研究者

发起方
T.N.M.C. and B.Y.L. Charitable Hospital.
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Harshvardhan Tikle

TNMC and B.Y.L. Charitable Hospital Mumbai

研究点 (1)

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