跳至主要内容
临床试验/CTRI/2025/04/085365
CTRI/2025/04/085365尚未招募2/3 期

Comparison of intrathecal morphine versus erector spinae plane block for postoperative pain control in patients for lumbar spine surgery:a double-blind prospective comparative study

Velammal medical college hospital and research institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年10月5日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
1.VAS Score.

研究概览

简要总结

After spine surgery,postoperative pain could be moderate to severe for more than half ofpatients.Surgical trauma, neuropathy and inflammation arefactors contributing to this.Erector spinae plane block isfascial plane block used widely for post operative analgesia of spinesurgeries.This involves injecting a local anesthetic into the plane between theerector spinae muscle and the transverse process of the vertebra. Thelocal anesthetic spreads on a plane caudally and cranially, allowing thesympathetic nerve fibers, as well as the spinal nerves’ dorsal and ventral ramito be blocked.Direct injection ofmorphine into the intrathecal space also allows to directly act onopioid receptors within the brain and substantia gelatinosa ofthe spinal cord resulting in a robust analgesia after spine surgeries.

The current study aimedto assess and compare the efficacy and safety of intrathecal morphinewith erector spinae plane block in patients undergoing electivelumbar spine surgeries.A total of 100 patients aged between 18 and 65 years ofeither sex will be selected from the patients posted for elective lumbar spine surgery. Patients will be divided into two groups: Group Apatients will receive 0.2 mg intrathecal morphine at any one space betweenL2-L5 level and Group B will receive bilateral erector spinae plane block atLumbar level L1-L5  by using 40 mL of 0.25 % bupivacaine before starting the surgery for postoperative analgesia. In theperioperative period, pain will be assessed by hemodynamic parameters(heart rate and mean arterial pressure,SpO2), visual analogue scale and patient satisfaction score. Timeto first rescue analgesic requirement and incidence of any adverse events willalso be noted.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

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 1 & 2 patients scheduled to undergo elective lumbar spine surgery.

排除标准

  • 1.Patient refusal.
  • 2.Allergy to any of the study drugs.
  • 3.Contraindications to regional technique e.g.,infection around site of block ,any coagulation disorder, sepsis.
  • 4.History of analgesic dependence (long term use) and opiate tolerance.
  • 5.Contraindications to intrathecal morphine e.g.,local infection in intrathecal administration site.
  • 6.More than two level of vertebrae involving in surgery.

结局指标

主要结局

1.VAS Score.

时间窗: 1.At the time of arrival in post-anesthesia care unit and then at 30 minutes, 1, 2, 4, 6, 12,24 and 48 hours. after operation.

2.Postoperative analgesia use paracetamol/tramadol usage.

时间窗: 1.At the time of arrival in post-anesthesia care unit and then at 30 minutes, 1, 2, 4, 6, 12,24 and 48 hours. after operation.

次要结局

  • 1.Time to first analgesic requirement after surgery.(2.Incidence of intervention related side effects in both the groups(Post-operative nausea/vomiting, respiratory depression, pruritus, urinary retention, local anesthetic systemic toxicity,local hematoma ).)

研究者

发起方
Velammal medical college hospital and research institute
申办方类型
Research institution and hospital

研究点 (1)

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