A comparative study of analgesic efficacy between transdermal buprenorphin patch and transdermal diclofenac patch for post operative pain relief in major surgeries
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- .Visual analog scale after complete recovery from general or spinal anaesthesia in group with Buprenorphine patch.
研究概览
简要总结
I want to conduct " A Comparative study of analgesic efficacy between transdermal buprenorphine patch and transdermal diclofence patch for post operative pain relief in major surgeries" for my MD Anaesthesia thesis.
AIM: This study aims to compare the efficacy of post operative pain relief with transdermal buprenorphine patch and transdermal diclofence patch.
OBJECTIVES: 1. Evaluation of post operative pain after complete recovery from general or spinal anaesthesia in group Buprenorphine using visual analog scale at 0, 2nd , 4th, 8th, 12th, 24th hours.
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Evaluation of post operative pain after complete recovery from general or spinal anaesthesia in group Diclofence using visual analog scale at 0, 2nd , 4th, 8th, 12th, 24th hours.
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To Comparison of total rescue analgesia required in both groups.
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Side effects and complications in group Buprenorphine and group Diclofence .
SETTING: Bharat Ratan Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon, Chhattisgarh
STUDY DESIGN: Prospective, Rendomized, Double blind, Interventional Study.
TIME FRAME: - February 2025 - April 2025
POPULATION/PARTICIPANTS: Patient between 18-60 years old, scheduled for major surgeries under general anaesthesia or spinal anaesthesia.
SAMPLE SIZE: Sample size of this study is taken as 62 with 31 sample in each group .
METHODS: Informed and written consent, Pre-anaesthetic evaluation, application of transdermal buprenorphine and diclofence patch. Pre
operative monitoring and medication, IV Access, Sub Arachnoid Block, General Anaesthesia, Proposed surgery, post operative pain assessment on VAS Scale
OUTCOME MEASURES: 1. Pain score on VAS Scalef or transdermal buprenorphine Patch.
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Pain score on VAS Scalef or transdermal diclofence patch.
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Total dose of rescue analgesia consumed.
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Side effect in each group.
STATISTICAL ANALYSIS: Statistical analysis will be performed by the SPSS program for Windows, version 20.0. continuous variables will be presented as mean +/- SD, and categorical variables will presented as absolute numbers and percentage. Data will checked for normality before statistical analysis. Comparison of mean for normally distributed continuous variables will be compared using the unpaired t test, whereas the Mann-Whitney U test will be used for those variables that will not be normally distributed. Categorical variables will be analyzed using either the chi square test or Fisher’s exact test .
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group: 18-60 years Patients posted for elective major surgeries under general anesthesia or spinal anesthesia with ASA-1 or ASA-2 grade.
排除标准
- •.Patients refusal .Pregnant and lactating women .Age more than 60 years .ASA grading more than or equal to 3 .History of allergy to Buprenorphine, Diclofenac, Paracetamol .Opioid Dependents .Cardiac, kidney, Liver disease and coagulation disorders .Patients with pain due to cause other than presenting illness.
结局指标
主要结局
.Visual analog scale after complete recovery from general or spinal anaesthesia in group with Buprenorphine patch.
时间窗: 0, 2nd, 4th, 8th, 12th, 24 hour after complete recovery from general or spinal anaesthesia in group with Buprenorphine patch and Diclofenac patch.
.Visual analog scale after complete recovery from general or spinal anaesthesia in group with Diclofenac patch.
时间窗: 0, 2nd, 4th, 8th, 12th, 24 hour after complete recovery from general or spinal anaesthesia in group with Buprenorphine patch and Diclofenac patch.
次要结局
- .Total rescue analgesia required in group with Buprenorphine patch and diclofenac patch(.Comperision of sode effects and complication in group with Buprenorphine patch and Diclofenece patch.)
研究者
Dr Anvita Shainy Lakra
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon