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临床试验/CTRI/2025/07/091982
CTRI/2025/07/091982尚未招募4 期

Comparison of Two Different Doses of Dexamethasone as an Adjuvant to Intrathecal Levobupivacaine on Analgesic Efficacy in Lower Abdominal Surgeries: A Randomised Controlled Study

UCMS and GTB Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年8月14日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Duration of effective analgesia with two different doses of dexamethasone as an adjuvant to nitrate al levobupivacaine in lower abdominal surgeries

研究概览

简要总结

Rationale: Subarachnoid block is the most commonly used technique for lower abdominal

surgery, but it provides limited duration of analgesia when the local anaesthetics are used alone.

Thus, additives can be added to prolong the analgesic efficacy. Dexamethasone has proven its

effectiveness for this purpose when used with local anaesthetics. However, the search of

literature did not find study comparing the analgesic efficacy of two different doses of

dexamethasone (2 mg and 4 mg) as an adjuvant to levobupivacaine in subarachnoid block in

patients undergoing lower abdominal surgeries.

Aim: To compare the analgesic efficacy of two different doses of dexamethasone as an

adjuvant to intrathecal levobupivacaine in lower abdominal surgeries.

Primary objective:

Analgesic efficacy: Duration of effective analgesia (Time from the subarachnoid block to the

time of patient’s first complaint of pain (VAS > 3).

Methods: On the day before surgery, the patients will be visited to explain about the procedure,

the type of medication to be used, its purpose and potential side effects. Written informed

consent will be obtained. For premedication, patients will be prescribed Tab Alprazolam 0.25

mg and Tab Ranitidine 150 mg, to be taken the night before surgery and repeated on the

morning of the procedure.

On the day of surgery, following the pre-anaesthetic assessment, the patient will be transferred

to the operating theatre and positioned on the operating table. Standard monitoring, including

non-invasive oscillometric blood pressure, Lead I ECG, and pulse oximetry, will be attached,

and baseline vital parameters (Heart Rate, Blood Pressure, SpOz and Respiratory Rate), Serum

Na* and Blood Sugar levels will be recorded. Intravenous (IV) access with 18 G IV cannula

will be secured, and preloading with Ringer’s lactate solution will be initiated at a dose of 15

mL/kg administered over 15-30 minutes.

OUTCOME MEASURES

  1. Analgesic efficacy: Duration of effective analgesia (Time from the subarachnoid block

to the time of patient’s first complaint of pain (VAS 3).

  1. Quality of sensory block.

  2. Quality of motor block.

  3. Side effects, if any.

Statistical Analysis:

Al the data collected will be managed in MS excel. The quantitative data will be represented

as mean (SD) & qualitative data will be represented as frequency.

The normality of the quantitative data set will be checked using KOLMOGROV SMIRNOV

TEST. The comparison between the 2 independent groups based on continuous variables will

be done using Independent T-test/ Mann Whitney U Test based on result of normality.

The threshold of statistical significance is p-value <0.05

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • Patients belonging to ASA grade I or II, between 18-65 years of age, and height 150-180 cm, scheduled for lower abdominal surgeries under subarachnoid block will be included in the study.

排除标准

  • Non-consenting for subarachnoid block Infection at injection site Coagulopathy Drugs addicts and chronic alcoholics Any spine deformity On antiarrhythmics Patients with history suggestive of space occupying lesion, increased intracranial tension, seizure disorder, pre-existing neurological deficit, hepatic and renal disease and pre-existing diabetes mellitus.

结局指标

主要结局

Duration of effective analgesia with two different doses of dexamethasone as an adjuvant to nitrate al levobupivacaine in lower abdominal surgeries

时间窗: The time from the subarachnoid block to the time of patient’s first complaint of pain VAS more than equal to 3 and till 24 hours from subarachnoid block

次要结局

  • Quality of sensory block(Quality of motor block)

研究者

发起方
UCMS and GTB Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Vibhor Gupta

University College of Medical Sciences and GTB Hospital

研究点 (1)

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