A randomized controlled trial to compare the efficacy of two different doses of pre emptive oral pregabalin on prolongation of spinal anesthesia and attenuation of postoperative pain
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Duration of sensory block (onset to regression to S1 dermatome).
研究概览
简要总结
Postoperative pain remains a significant healthcare challenge globally, with approximately 80% of surgical patients experiencing acute pain, and nearly 50% reporting inadequate pain relief despite advances in pain management techniques. The incidence of moderate-to-severe postoperative pain ranges from 31% to 58% even after hospital discharge, contributing to delayed mobilization, prolonged hospitalization, increased healthcare costs, and potential development of chronic postsurgical pain which affects 20-30% of patients at 6-12 months post-surgery.Lower abdominal surgeries under spinal anesthesia are particularly associated with significant postoperative pain that can impair recovery and patient satisfaction.
Current knowledge regarding pregabalin’s optimal dosing for preemptive analgesia in spinal anesthesia remains limited and contradictory. While several studies have demonstrated pregabalin’s efficacy in reducing postoperative pain and opioid consumption, there exists significant variability in dosing regimens ranging from 75mg to 600mg, with no consensus on the optimal dose. Most research has focused on general anesthesia, with limited studies specifically evaluating pregabalin’s effects on spinal anesthesia characteristics. Additionally, direct comparative studies between different pregabalin doses in the context of spinal anesthesia for lower abdominal surgeries are scarce. The mechanisms by which pregabalin prolongs motor and sensory blocks in spinal anesthesia are not fully understood, and there remains uncertainty about the dose-response relationship for optimal analgesic efficacy while minimizing adverse effects.
This study aims to bridge this critical knowledge gap by directly comparing two clinically relevant doses of pregabalin (75mg versus 150mg) in patients undergoing lower abdominal surgeries under spinal anesthesia. Such comparative evaluation is essential to establish evidence-based dosing guidelines that maximize analgesic efficacy while minimizing side effects, ultimately improving patient outcomes and optimizing perioperative pain management protocols in this specific surgical population.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.ASA 1 and 2 2.patient scheduled for elective lower abdominal and lower limb surgeries 3.BMI 18 to 35 kg/m2.
排除标准
- •1.Allergy to pregabalin 2.contraindication to spinal anesthesia, 3.Renal/hepatic dysfunction 4.chronic analgesic use 5.refusal to participate.
结局指标
主要结局
1. Duration of sensory block (onset to regression to S1 dermatome).
时间窗: 1. Duration of sensory block (onset to regression to S1 dermatome). | 2. Duration of motor block (onset to Bromage score 0). | 3. Time to first rescue analgesic (minutes from block administration to first analgesic | request). | 4. Total opioid requirement within 24 hours (tramadol and paracetamol equivalents). | 5. Pain intensity using the Visual Analogue Scale (VAS). | 6. Side effects (nausea, vomiting, dizziness, sedation, respiratory depression).
2. Duration of motor block (onset to Bromage score 0).
时间窗: 1. Duration of sensory block (onset to regression to S1 dermatome). | 2. Duration of motor block (onset to Bromage score 0). | 3. Time to first rescue analgesic (minutes from block administration to first analgesic | request). | 4. Total opioid requirement within 24 hours (tramadol and paracetamol equivalents). | 5. Pain intensity using the Visual Analogue Scale (VAS). | 6. Side effects (nausea, vomiting, dizziness, sedation, respiratory depression).
3. Time to first rescue analgesic (minutes from block administration to first analgesic
时间窗: 1. Duration of sensory block (onset to regression to S1 dermatome). | 2. Duration of motor block (onset to Bromage score 0). | 3. Time to first rescue analgesic (minutes from block administration to first analgesic | request). | 4. Total opioid requirement within 24 hours (tramadol and paracetamol equivalents). | 5. Pain intensity using the Visual Analogue Scale (VAS). | 6. Side effects (nausea, vomiting, dizziness, sedation, respiratory depression).
request).
时间窗: 1. Duration of sensory block (onset to regression to S1 dermatome). | 2. Duration of motor block (onset to Bromage score 0). | 3. Time to first rescue analgesic (minutes from block administration to first analgesic | request). | 4. Total opioid requirement within 24 hours (tramadol and paracetamol equivalents). | 5. Pain intensity using the Visual Analogue Scale (VAS). | 6. Side effects (nausea, vomiting, dizziness, sedation, respiratory depression).
4. Total opioid requirement within 24 hours (tramadol and paracetamol equivalents).
时间窗: 1. Duration of sensory block (onset to regression to S1 dermatome). | 2. Duration of motor block (onset to Bromage score 0). | 3. Time to first rescue analgesic (minutes from block administration to first analgesic | request). | 4. Total opioid requirement within 24 hours (tramadol and paracetamol equivalents). | 5. Pain intensity using the Visual Analogue Scale (VAS). | 6. Side effects (nausea, vomiting, dizziness, sedation, respiratory depression).
5. Pain intensity using the Visual Analogue Scale (VAS).
时间窗: 1. Duration of sensory block (onset to regression to S1 dermatome). | 2. Duration of motor block (onset to Bromage score 0). | 3. Time to first rescue analgesic (minutes from block administration to first analgesic | request). | 4. Total opioid requirement within 24 hours (tramadol and paracetamol equivalents). | 5. Pain intensity using the Visual Analogue Scale (VAS). | 6. Side effects (nausea, vomiting, dizziness, sedation, respiratory depression).
6. Side effects (nausea, vomiting, dizziness, sedation, respiratory depression).
时间窗: 1. Duration of sensory block (onset to regression to S1 dermatome). | 2. Duration of motor block (onset to Bromage score 0). | 3. Time to first rescue analgesic (minutes from block administration to first analgesic | request). | 4. Total opioid requirement within 24 hours (tramadol and paracetamol equivalents). | 5. Pain intensity using the Visual Analogue Scale (VAS). | 6. Side effects (nausea, vomiting, dizziness, sedation, respiratory depression).
次要结局
未报告次要终点
研究者
DR TEJAS G
Sapthagiri Institute Of Medical Science and Research Centre