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临床试验/NCT01201499
NCT01201499Unknown不适用

The Impact of Two Different Intraoperative Analgesia Techniques on Post-operative Outcome After Hepato-pancreato-biliary Surgery

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2010年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
140
试验地点
1
主要终点
postoperative pain

研究概览

简要总结

Inadequate pain control after abdominal procedures may lead to adverse postoperative outcome. Epidural analgesia is currently an accepted technique in abdominal surgery, but its use has been limited in liver resections by postoperative coagulation disturbances and the possible increased risk of bleeding complications, including spinal hematoma. A range of alternative analgesic techniques can be used for major liver or pancreatic resections, including intrathecal morphine (single shot) administered immediately before surgery, and continuous administration of intravenous (IV) short-acting opioids, such as remifentanil, plus a single bolus of IV morphine. Postoperatively analgesia may be obtained by patient-controlled morphine analgesia (IV PCA). Both protocols have been demonstrated to provide satisfactory postoperative pain relief, and each has its unique advantages. However, to this end there is no data in the literature to show benefit from one regimen over the other. We therefore wish to determine whether there is a difference in analgesic efficacy between the two techniques, as optimizing perioperative pain relief in this rapidly expanding surgical field is of utmost importance. Our hypothesis is that continuous intraoperative IV analgesia with remifentanil followed by IV PCA morphine is not inferior to intrathecal morphine with respect to analgesia and ambulation outcome, and may provide an alternative, non-invasive intraoperative analgesic technique.

详细描述

BACKGROUND Inadequate pain control after abdominal procedures might result in increased morbidity, length of stay, and delay in overall recovery. Epidural analgesia is currently an accepted technique in major abdominal surgery [1-4]. Postoperative coagulation disturbances related to liver surgery, even in patients with normal preoperative coagulation undergoing uncomplicated hepatectomy, raises concerns about the safety of postoperative analgesia administered through an epidural catheter. Coagulation changes after liver surgery and the possible increased risk of bleeding complications, including spinal hematoma, have limited the use of epidural analgesia [5-7].

A range of alternative analgesic techniques can be used for major liver or pancreatic resections. A single dose of intrathecal morphine (ITM), administered immediately before surgery, followed by postoperative patient-controlled morphine analgesia (IV PCA), has been demonstrated to provide satisfactory postoperative pain relief which was not inferior to continuous epidural analgesia up to 48 hours after hepatic surgery [8, 9]. Another study in patients undergoing hepato-pancreato-biliary surgery has shown that ITM, compared with thoracic epidural analgesia, is associated with a reduced incidence of postoperative hypotension, intravenous fluid requirements, hospitalization, and incidence of respiratory complications [10]. Alternatively, few reports have demonstrated the advantage of using continuous administration of intravenous (IV) short-acting opioids, such as remifentanil. This regime has been shown to facilitate earlier extubation, to provide excellent intraoperative hemodynamic stability and rapid recovery [11]. Nevertheless, as remifentanil is rapidly metabolized, there is a need at the end of surgery to initiate another post-operative pain strategy to prevent unacceptable pain in the post-operative period. This has been accomplished by the administration of morphine which has been shown to provide an effective postoperative pain control (a bolus followed by IV PCA).

To date, these two analgesic regimens (ITM vs. continuous IV remifentanil) are frequently used in our institution. Nevertheless, there is no data in the literature to show benefit from one regimen over the other. We therefore wish to determine whether there is a difference in analgesic efficacy between the two techniques as optimizing perioperative pain relief in this rapidly expanding surgical field is of utmost importance.

METHODS Study design The study will be conducted as a prospective, randomized, double blinded one. Intra-operatively, anesthesia and surgical management will follow the routines. Intravenous fluid and blood supplements will be administered according to the anesthesiologists' decision. Also, the decision to extubate the patient at the end of surgery will be left to the discretion of the anesthesiologist. Post-operatively, all patients will be transferred to the ICU or to the recovery room for at least 24 hours. Patients may also be transferred first to the recovery room and than to the ICU. These are the routines in our hospital.

Consented patients will be randomly allocated to two groups by a computer-generated list:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA physical status I-III patients (> 18 years old), scheduled for elective liver resection, pancreatic resection or pancreaticoduodenectomy ("Whipple" procedure) at Tel Aviv-Sourasky Medical Center.

排除标准

  • Contraindications to the spinal technique, allergy to the study drugs, patients treated with opioids for chronic pain, patients with obstructive sleep apnea, morbidly obese patients, pregnant women, patient requiring mechanical ventilation at the end of surgery.

研究组 & 干预措施

Intrathecal morphine

Active Comparator

A single shot of intrathecal morphine given before the induction of general anesthesia. Followed by postoperative IV patient-controlled morphine analgesia.

干预措施: Intrathecal morphine (Drug)

Continuous IV remifentanil

Active Comparator

Continuous administration of IV remifentanil during surgery, supported by a single bolus of IV morphine at the end of surgery. Followed by postoperative IV patient-controlled morphine analgesia.

干预措施: Continuous IV remifentanil (Drug)

结局指标

主要结局

postoperative pain

时间窗: 72 hours

Pain will be assessed 72 hours post-operatively by: 1. A subjective visual analogue pain score (VAS, scale 0-10 cm) during rest, while coughing. 2. Time to first postoperative request of analgesia (from IV PCA). 3. Cumulative postoperative analgesia consumption (demand/delivery ratio). 4. Need for supplementary of alternative analgesia

次要结局

  • Recovery and adverse effects(72 hours)

研究者

申办方类型
Other Gov

研究点 (1)

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