Comparison of Postoperative Analgesic Effectiveness of Bupivacaine and Bupivacaine Plus Dexmedetomidine Wound Infiltration in Abdominal Surgeries Under General Anesthesia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Duration of analgesia
研究概览
简要总结
Abdominal surgeries are major surgical procedures that are performed at any teaching hospital. Pain control is major concern in the intra-operative as well as post-operative period in these patients. Optimal pain control in post-operative period is directly related to patient's recovery, shortens the patients' hospital stay and overall burden on health facilities. Inadequate pain control may affect quality of life and increases patient's morbidity and mortality. Different modalities for pain control are used in post-operative period. Opioids are mainstay of treatment in post-operative period but historically are associated with significant side effect profile like dependence, nausea, vomiting, respiratory depression, constipation and many others. Dexmedetomidine is centrally acting α-2 adrenoceptor agonist.
详细描述
This randomized controlled trial was conducted at Department of Anesthesia, Sahiwal Teaching Hospital, Sahiwal. After institutional review board (IRB) approval, computer-generated random number table was used to randomize the patients to two groups, one group received Bupivacaine plus placebo and the other group received Bupivacaine plus dexmedetomidine. A total of 64 patients met the inclusion criteria and were enrolled in the study in a 1:1. Informed written consent was obtained from all the patients before enrolling them in the study. All patients underwent a pre-operative assessment on the day before surgery. Both groups received wound infiltration with studied drugs at the end of surgery. After surgery patients were shifted to post-surgical ward and assessed for pain using visual analogue scale (VAS) and data was collected and analyzed using Statistical Package for the Social Sciences (SPSS) version 26. Quantitative variables were presented with mean ±SD. Comparison of quantitative variable between groups was done using independent sample t-test. Comparison of qualitative variable like (Opioid sparing effect, Bradycardia, Hypotension, Nausea, Vomiting) was presented with frequency and percentages. Data was stratified on the basis of gender and age. Post-stratification chi-square test was used to compare both groups for opioid sparing effect in each stratum with p-value ≤0.05 as significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Both patients and assessor were unaware of interventions
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age limit: 18-60 years
- •Gender of patient i.e., male or female
- •Patients listed for abdominal surgeries
- •American Society of Anesthesiologists (ASA) status of I or II
排除标准
- •Patients with history of drug allergy
- •Patients who undergone any analgesia in past 24 hr
- •Patients with liver disease, kidney disease, cardiac disease, sickle cell anemia, severe preeclampsia or CNS disorder on history, clinical and laboratory assessment
- •American Society of Anesthesiologists (ASA) status III or IV
- •Patients with morbid obesity 6, Raynaud's disease Patients on adrenoceptor agonists, antagonists or narcotics before the operation.
研究组 & 干预措施
Bupivacaine group
Patients receiving Bupivacaine plus placebo for wound infiltration after abdominal surgery for pain control.
干预措施: bupivacaine wound infilteration (Drug)
Bupivacaine plus Dexmedetomidine group
Patients receiving Bupivacaine plus Dexmedetomidine for wound infiltration after abdominal surgery for pain control.
干预措施: Bupivacaine plus dexmedetomidine wound infilteration (Drug)
结局指标
主要结局
Duration of analgesia
时间窗: Every 30 mints for 4hrs than 2hrly for 24 hrs post procedure
Time from procedure to requirement of rescue analgesia
次要结局
- Opioid sparing(Total dose of nalbuhine consumption in 1st 24 hrs after procedure)
- Blood pressure(Every 15 minutes intra operative and every 15 minutes for 24 hrs postoperatively)
- Vomiting(Every 3 minutes for first 4 hrs then 2hrly for 24 hrs)
- Hear rate(Every 15 minutes intraoperative and every 15 minutes postoperatively for 24 hrs)
- Neausea(Every 30 minutes for 4 hrs then 2hrly for 24 hrs)
研究者
Muhammad Shahid
Associate Professor
Sahiwal medical college sahiwal