Comparison of lower dose of intrathecal morphine with fentanyl versus intrathecal morphine on post operative outcomes in patients undergoing renal transplant: a randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- To demonstrate that intrathecal (100 microgram) morphine + (15 microgram) fentanyl provides a postoperative quality of recovery (QoR15) that is non-inferior to 200 microgram intrathecal morphine on postoperative day 1
研究概览
简要总结
Post operative pain remains a challenge for patients especially after a major surgery. Renal transplant surgery presents a major post operative pain owing to its large incision site and its association with its somatic and visceral pain as well as the complexity of the patient’s comorbidities. Transplant recipients have often underlying conditions such as hypertension and cardiovascular disease which can complicate pain management strategies.
Intrathecal morphine provides excellent and long lasting analgesia after different types of surgical procedure due to its hydrophilic nature, maintaining CSF concentration for longer duration (24-48 hours) with slower onset (45-60 minutes).
Intrathecal fentanyl has been relatively used in caesarian sections, lower extremity surgery , urology and ambulatory day surgeries and found it to be effective in improving postoperative pain due its lipophilic nature having a high affinity to receptors and produces a rapid onset of action (10-20 minutes). But, it can also rapidly diffuse rapidly into non neuronal tissues such as myelin and epidural fat causing CSF concentration to fall rapidly and shortening its duration of action (4-6 hours).
We hypothesized that with intraoperative administration of lower dose of morphine with fentanyl, the dose dependant side effects of morphine might be diminished, improve immediate postoperative pain control resulting in reduced post operative opioid intake and improved outcomes for patients undergoing renal transplant surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •ASA 2/3 undergoing live related renal transplant.
排除标准
- •Patient refusal History of allergy to study drug Coagulopathy Severe cardiac disease Deceased donor renal transplant Patients who are intubated for at least a minimum duration of 24 hours.
结局指标
主要结局
To demonstrate that intrathecal (100 microgram) morphine + (15 microgram) fentanyl provides a postoperative quality of recovery (QoR15) that is non-inferior to 200 microgram intrathecal morphine on postoperative day 1
时间窗: postoperative day 1
次要结局
- Requirement of rescue analgesia(24 hours postoperatively)
- respiratory depression(postop hours 1, 6, 12, 24, 36, 48)
- To demonstrate that both the treatment groups perform better than the control group (no intrathecal opioids)(24 hour post operatively)
- Pruritis(postop hours 1, 6, 12, 24, 36, 48)
- NRS (Numerical rating scale) score for pain(postop hours 1, 6, 12, 24, 36, 48)
- Postoperative nausea, vomiting(postop hours 1, 6, 12, 24, 36, 48)
- time to first mobilisation(48 hours postoperative)
- duration of hospital stay(end of surgery till hospital discharge)
- incidence & duration of post operative mechanical ventilation(28 days)
- incidence of delayed graft function(7 postoperative days)