Evaluation of analgesic efficacy of clonidine as an additive to isobaric levobupivacaine in patients undergoing lower limb surgeries: A randomised controlled study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Duration of effective analgesia
研究概览
简要总结
Subarachnoid block will be given insitting position under all aseptic precautions at the level of L2-L3or L3-L4 intervertebral space as per the standardprotocol. Intrathecal drug will be given according to the group allotted asunder:
Group-LC:15 mg of 0.5% isobaric levobupivacaine (3ml) + 15µg of clonidine (0.15ml)
Group-LS: 15 mg of 0.5% isobaric levobupivacaine (3ml) + normalsaline (0.15ml)
The total volume of intrathecal drugwill be 3.15 ml in both the groups.
Block characteristics will be assessedusing loss of pinprick sensation for sensory block and Bromage Score for motorblock. Hemodynamic variables will also be recorded.
Statistical analysis will be carriedout in SPSS, software version 20.0 or latest. The quantitative parameters likeage, height, weight, time of onset of block (when the sensory block is achievedat level of T10 dermatome), maximum height of sensory blockachieved, duration of effective analgesia (time from giving subarachnoid blockto patient’s first complaint of pain (VAS ≥ 3) and rescue analgesia given topatient which are recorded at onetime point will be compared usingunpaired t-test. Qualitative data likegender distribution, ASA physical status, quality of muscle relaxation,intensity of motor block and VAS score will be analysed using the Chi-squaretest or Fisher’s exact test whichever is applicable. Repeated measures ANOVAwill be used to compare the hemodynamic variables. A p-value < 0.05 will beconsidered significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade I or II between 18-65 years height 150-180 cm.
排除标准
- •â€¢Patients who do not give consent for subarachnoid block.
- •Patients with contraindication to subarachnoid block: infection at injection site, coagulopathy, space-occupying lesion, increased intracranial tension, known case of seizure disorder, pre-existing neurological deficit, and spine deformity.
- •History of allergy to any drug being used in the study.
- •Pregnant patients.
- •Known case of hepatic and renal disease, drug addicts and chronic alcoholics.
- •Patients who are on antiarrhythmic drugs.
结局指标
主要结局
Duration of effective analgesia
时间窗: ONce | Time from the subarachnoid block to the time of patient’s first complaint of pain and VAS more than 3
次要结局
- Sensory and motor block charactersitics(every 2 min for the first 10 min and then every 5 min till the same level is obtained in 3 consecutive readings)