The Use of Venous Cannulation Pain for Evaluation of Pain Sensitivity in an Attempt to Guide Pain Therapy During and Following Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Acute postoperative pain
研究概览
简要总结
The investigators have recently shown that pain associated with peripheral venous cannulation can be used to predict the risk of postoperative pain, where patients grading their pain associated with venous cannulation (VCP) above 2.0 VAS units had 3.4 times higher risk of moderate or severe postoperative pain after laparoscopic cholecystectomy and 1.7 times higher risk in a mixed group of patients and surgeries.
The aim of this study is to investigate whether pain sensitivity measurements using VCP can be used to choose anesthesia treatment protocol with the aim to lower acute postoperative pain in those with high risk. In patients with low risk we aim to lower the amount of opioids given.
详细描述
The investigators will perform a randomized controlled trial randomizing patients to different treatment protocols depending on their pain associated with venous cannulation. There will be two set of instructions for perioperative treatment, one for those grading pain associated with venous cannulation <2.0 (low-pain) and another for those grading VCP ≥2.0 (high-pain).
The low-pain group will be randomized to standard treatment or opioid-free anesthesia. The high-pain group will be randomized to standard treatment or extra in form of additives like esketamine and clonidine.
In the low-pain group the investigators aim for non-inferiority with the gain being avoiding opioids. In the high-pain group the investigators aim for lower post-operative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The participant will be blinded to allocation arm. The anesthesia nurses, the anesthesiologist and the PACU-nurse will not be blinded to the intervention. The assistant nurse performing the postoperative pain assessments will be blinded to allocation group. Once the assistant nurse has performed the assessment the PACU-nurse will decide on treatment depending on allocation and specific instructions.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with an American Society of Anesthesiologists (ASA) physical status I or II, undergoing elective laparoscopic surgery at Hallands´ hospital.
排除标准
- •Inability to understand information regarding the study. Refusal to give consent. Severe cardiovascular disease. AV-block II. Requirement of additional procedures during surgery, like conversion of laparoscopic to open surgery, incomplete registration of study measurements.
结局指标
主要结局
Acute postoperative pain
时间窗: Acute, within 1.5 hours after surgery
Difference in mean APOP between groups (Opioid free vs Standard of care, Multimodal vs Standard of care). Reported as difference in NRS (numeric rating scale; 0-10 with 0 describing no pain and 10 the worst pain imaginable) with confidence interval (CI).
次要结局
- Proportion of patients with moderate-severe postoperative pain(Acute, 24 hours and 3 months after surgery)
- Venous cannulation pain for prediction of acute postoperative pain(Acute; within 24 hours)
- Difference in persistent pain between groups.(Three months after surgery.)
- Quality of recovery(Acute; within 24 hours)
- Association between pain catastrophizing scale and venous cannulation pain(Preoperative measurement)
- Association between pain catastrophizing and postoperative pain(At 3 months after surgery)
- Persistent postoperative pain(At three months after surgery)
- Venous cannulation pain for prediction of persistent postoperative pain(Three months after surgery)
研究者
Anna Persson
MD, PhD, Consultant in Anaesthesia and Intensive Care Medicine
Region Halland