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临床试验/NCT00163553
NCT00163553Unknown3 期

Neuraxial Pethidine After Lumbar Surgery Trial

Austin Health1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2004年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
Austin Health
入组人数
60
试验地点
1
主要终点
Cumulative 24-hour pethidine consumption

研究概览

简要总结

The hypothesis is that epidural pethidine is an effective form of pain relief following lumbar spinal surgery, resulting in significantly lower usage of concomitantly administered (intravenous) patient-controlled analgesia (PCA) pethidine.

详细描述

Rationale Lumbar laminectomy is commonly performed to alleviate local or nerve root pain in the lower back and legs. Post-operative pain relief may consist of oral or parenteral medication, with an increasing body of research focussing on the use of epidural analgesics and anaesthetics (see references). It is the current practice of surgeons at this hospital to use an epidural infusion of pethidine in some patients.

Epidural medication has sometimes been administered at the conclusion of an operation as a single dose, in the form of a spray1 2 3, paste 4, or been sponged onto the exposed epidural space.5 Agents used in this manner have included morphine, tramadol, buprenorphine and methylprednisolone. In one such study Bourke6 found that a single dose of epidural morphine 3 mg reduced pain scores and analgesic requirements for 24 hours when compared to the same dose given intramuscularly, suggesting that direct epidural administration is superior to parenteral administration.

As an alternative, analgesics have been infused post-operatively via and epidural catheter placed at the end of surgery under direct vision. Cohen7 compared an epidural infusion of morphine and bupivacaine to PCA morphine in 54 patients and found no difference in outcome between groups. Other studies which have been uncontrolled or unblinded have demonstrated the efficacy of epidural narcotic administration (morphine, fentanyl and hydromorphone) following lumbar laminectomy surgery.8 9 10 11 12 Thus there is some evidence supporting the use of this form of analgesia, despite a report of an incidence of technical failure in surgically-positioned epidural catheters. 13

To date, no published study has investigated the use of epidural pethidine following lumbar laminectomy. Pethidine has some theoretical advantage over other agents used.14 As an opioid with intermediate lipid solubility, it is less likely to leave the epidural space than fentanyl. The low lipid solubility of morphine increases its likelihood of causing central respiratory depression as it crosses the dura to the site of action at a slower rate than pethidine.14 Pethidine also has an intrinsic local anaesthetic activity.

An early study showed that patients receiving a single dose of epidural pethidine at the end of major surgery had a longer period before further analgesics were required than patients receiving equipotent doses of morphine or pethidine. Blake15 compared patient-controlled epidural pethidine (PCEA) with intravenous patient-controlled analgesia (PCA) pethidine following abdominal aortic surgery, where all patients also received epidural bupivicaine. The PCEA group had lower pain scores, despite having lower plasma pethidine concentrations, confirming the central action of epidural pethidine. In a similar study, Chen16 compared epidural and PCA pethidine in 37 patients following gastrectomy. Pain and satisfaction scores were similar, but the epidural group had lower plasma concentrations of pethidine and norpethidine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults undergoing lumbar spinal surgery

排除标准

  • Lack of informed patient consent
  • Acute or chronic renal failure
  • Known allergy or intolerance to pethidine or tramadol
  • Chronic respiratory insufficiency
  • Epidural contraindicated (coagulopathy, systemic infection)

研究组 & 干预措施

P

Experimental

Epidural pethidine group

干预措施: Pethidine (Drug)

N

Placebo Comparator

placebo group

干预措施: Placebo (Drug)

结局指标

主要结局

Cumulative 24-hour pethidine consumption

时间窗: 24 hours

次要结局

  • Body mass index
  • Dural tear at the time of surgery (yes/no)
  • Patient data:
  • Age
  • Gender
  • Current medications
  • Preoperative opioid analgesic use (none, low, high - high dose being > 300 mg codeine or dextropropoxyphene daily or oral morphine or parenteral opioid use)
  • Compensable status (HNC, TAC, WCV or PMI/SUR) 22
  • Surgical data:
  • Anatomical extent of surgery (number of spinal levels)
  • Highest anatomical surgical level
  • Experience level of primary surgeon (trainee or consultant)
  • Anatomical level of epidural tip (identified from postoperative X-Ray when taken as routine care only)
  • Spinal instrumentation (yes/no)
  • Other end-points (all at 1, 4, 24 and 48 hours unless stated):
  • Cumulative pethidine dose
  • Cumulative morphine dose
  • VAS scores for pain at rest and during movement
  • Sedation score (1 - 4) 16
  • VAS scores for nausea, pruritis
  • Other adverse events: agitation, tremor, hallucinations, seizure
  • Patient satisfaction scale for pain control during study (48 hours)(48 hours)
  • (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied) 17
  • Plasma pethidine and norpethidine levels (24 hours)(24 hours)
  • Physiotherapy assessment of ability to deep breathe & cough (unable, poor, adequate, good)
  • Length of inpatient stay

研究者

发起方
Austin Health
申办方类型
Other Gov

研究点 (1)

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