Efficacy Of Intrathecal Ropivacaine And Morphine Versus Intrathecal Morphine Alone As Preventive Analgesia In Patients Undergoing Posterior Lumbar Spine Surgery: A Prospective Randomized Double Blind Comparative Study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1) To compare the analgesic efficacy between group A and group B postoperatively for 24 hrs using NRS score at various intervals
研究概览
简要总结
Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage (definition by IASP). There are four major types of pain, nociceptive pain (due to tissue injury), inflammatory pain, neuropathic pain (due to nerve irritation) functional pain (due to no obvious origin). Pain has seven dimensions or core aspects: physical, sensory, behavioral, socio-cultural, cognitive, affective, and spiritual. Lumbar spine surgery is routinely performed in patients for various indications to mitigate back pain, lessen neurological symptoms, and improve mobility. The major indications broadly include trauma, infection, malignancy, congenital, and degenerative disease. It is known to be a major surgical procedure associated with severe postoperative pain requiring comprehensive management. Poorly managed postoperative analgesia culminates into delayed mobilization, prolonged hospital stay, morbidity and delayed rehabilitation. There is growing evidence that acute post-operative pain also influences the development of chronic pain through central or peripheral sensitization of receptors. Recently, enhanced recovery programs necessitate satisfactory analgesia and a number of modalities ranging from nonsteroidal anti-inflammatory drugs, opioids, and local anaesthetics have been used. Multimodal analgesia is an invaluable tool for escalating recovery. One of the methods for post-operative analgesia that has gained popularity in recent years is the intrathecal opioid administration in which opioid is directly injected into cerebrospinal fluid and acts directly on the opioid receptors present in the substantia gelatinosa and inhibit presynaptic and postsynaptic nociceptive transmission without sympathetic effects. Morphine, the prototypical opioid, has been the most widely accepted for intrathecal administration. Intrathecal morphine has a good role in post-operative pain management as it produces segmental analgesia, which causes localized nociception without sensory, motor, autonomic, or systemic side effects. However, it is associated with various side effects in postoperative period such as pruritus, somnolence, respiratory depression, vomiting and urinary retention. This makes it imperative that the dose of opioids needs to be attenuated to avoid unwanted side effects that impede recovery. Preemptive analgesia entails adopting techniques prior to pain registration in the central neurons and further amplification. The onset of action of morphine starts from 30-60 minutes and it can last for about 4-24 Hours. Local anaesthetic drugs such as ropivacaine have been used for spinal anaesthesia in spine surgeries and have immediate onset of action. Anesthesiologists have been combining local anesthetic (bupivacaine) with morphine so as to reduce its dose. Intrathecal morphine in combination with local anesthetic is an emerging technique wherein the onset of analgesia is immediate and dose of morphine may be further reduced, providing preventive analgesia. Hence we designed this study to compare the analgesic efficacy of 0.2% ropivacaine plus 200 mcg of intrathecal morphine with 200 mcg of intrathecal morphine in posterior lumbar spine surgery.
**RESEARCH QUESTION OF THE STUDY -**To determine whether adding ropivacaine to low dose intrathecal morphine provides superior analgesia as compared to intrathecal morphine alone in patients undergoing lumbar spine surgeries?
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 70.00 Year(s)(—)
- 性别
- All
入选标准
- •ASA I & II patients aged 18 years to 70 years undergoing lumbar spine surgery.
排除标准
- •Known allergies to morphine or other opioids & ropivacaine.
- •Spine surgery other than lumbar spine 3) H/o severe respiratory illness (COPD/ Asthma) 4) H/o OSA (Obstructive Sleep Apnoea) 5) Pregnancy 6) Patient on sustained narcotics/ substance abuse 7) Patient lacking mental capacity to use PCA 8) Patient undergoing revision of previous lumbar spine surgery 9) Patient with psychiatric disorders 10) Patient not giving consent.
结局指标
主要结局
1) To compare the analgesic efficacy between group A and group B postoperatively for 24 hrs using NRS score at various intervals
时间窗: 1) To compare the analgesic efficacy between group A and group B postoperatively for 24 hrs using NRS score at various intervals | 2) To note and compare time for first rescue analgesia.
2) To note and compare time for first rescue analgesia.
时间窗: 1) To compare the analgesic efficacy between group A and group B postoperatively for 24 hrs using NRS score at various intervals | 2) To note and compare time for first rescue analgesia.
次要结局
- To compare the total consumption of opioids in 24 hours post-operatively.(24 hours postoperatively)
研究者
Dr. Anju Jacob
BLK-Max Super Speciality Hospital (Formerly Dr. B.L. Kapur Memorial Hospital)
