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临床试验/NCT02647047
NCT02647047Unknown不适用

Spinal Analgesia Versus Epidural Analgesia in Minor Laparotomic Liver Surgery in an Enhanced Recovery Programme: A Randomized Controlled Trial

Ospedale San Raffaele1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年1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
发起方
入组人数
40
试验地点
1
主要终点
Assessment of postoperative pain control by mean of the visual analog scale early after surgery

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of spinal analgesia for minor laparotomic hepatectomy compared with epidural analgesia, monitoring visual analog scale (VAS). The investigators expect at least the same post-operative pain control in the two groups (non inferiority of pain control with spinal analgesia compared to epidural analgesia). Second endpoint is to verify whether after spinal analgesia there is a decrease in patient's length of hospitalization according to enhanced recovery after surgery (ERAS) principles.

详细描述

Liver surgery is performed under general anesthesia. Loco-regional analgesia is generally performed before general anesthesia induction to obtain the best post-operative pain control,in association with intravenous analgesic drug administration.

For minor laparotomic surgery (defined as the resection of up to three hepatic segments), if not contraindicated, in our hospital loco-regional analgesia is performed through the placement of a thoracic (T7-T8 or T8-T9) epidural catheter in which a local anesthetic (usually ropivacaine) and an opioid (usually sufentanil) are administered for the first three post-operative days. This is still considered the gold-standard for pain management in this surgery. In our institute, there is a dedicated acute pain service (APS) for pain management in the post-operative period. APS is also responsible for monitoring, registering and treating all side effects related to both the procedure and the drugs used.

In laparoscopic abdominal surgery, instead of epidural analgesia, if not contraindicated, spinal analgesia with low dose morphine before general anesthesia induction is performed. This technique is actually considered efficacy and safe in these type of surgeries.

The investigators therefore decided to test the efficacy of spinal analgesia versus epidural analgesia for minor liver surgery since anterior hepatic segments resection is less painful than major liver surgery because it requires less liver manipulation without significant involvement of the Glisson's capsule. This might imply a less incidence of procedure-related side effects such as post-dural puncture headache or site infections. Moreover, spinal analgesia may allow a earlier post-operative patients mobilization and thus a earlier hospital discharge.

In this randomized controlled trial, the investigators therefore aim to randomize 40 consecutive patients into 2 arms. The experimental group will receive spinal analgesia (morphine 0.2 mg) for post-operative pain control while the control group will receive epidural analgesia (bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2%: 99 mL + sufentanil 50 mcg/mL: 1 mL).

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
None

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

  • Age > 18 years old
  • Hospitalized patients
  • Surgical indication for minor laparotomic anterior liver resection (II, III, IV and V hepatic segment resection)
  • Surgical indication for laparotomic liver metastasectomy
  • Ability to provide an informed consent

排除标准

  • Patient refusal to provide informed consent
  • Chronical therapy with opioids
  • Pregnancy or breastfeeding
  • Alcohol or drug abuse
  • Planned or unplanned post-operative intensive care unit admission
  • Contraindication to spinal/epidural analgesia
  • Severe liver or renal failure
  • Cognitive disorders, mental retard or psychiatric disorders
  • Allergy to any drug used

研究组 & 干预措施

Spinal

Experimental

Patients will receive spinal analgesia (morphine 0.2 mg) before general anesthesia for minor laparotomic liver resection.

干预措施: Spinal analgesia (Procedure)

Spinal

Experimental

Patients will receive spinal analgesia (morphine 0.2 mg) before general anesthesia for minor laparotomic liver resection.

干预措施: Transversus Abdominis Plane block (Procedure)

Spinal

Experimental

Patients will receive spinal analgesia (morphine 0.2 mg) before general anesthesia for minor laparotomic liver resection.

干预措施: Surgical wound infiltration (Procedure)

Spinal

Experimental

Patients will receive spinal analgesia (morphine 0.2 mg) before general anesthesia for minor laparotomic liver resection.

干预措施: Acetaminophen (Drug)

Spinal

Experimental

Patients will receive spinal analgesia (morphine 0.2 mg) before general anesthesia for minor laparotomic liver resection.

干预措施: Ketorolac (Drug)

Spinal

Experimental

Patients will receive spinal analgesia (morphine 0.2 mg) before general anesthesia for minor laparotomic liver resection.

干预措施: Ropivacaine (Drug)

Epidural

Active Comparator

Patients will receive epidural analgesia (bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL + sufentanil 50 mcg/mL 1 mL) before general anesthesia for minor laparotomic liver resection.

干预措施: Epidural analgesia (Procedure)

Epidural

Active Comparator

Patients will receive epidural analgesia (bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL + sufentanil 50 mcg/mL 1 mL) before general anesthesia for minor laparotomic liver resection.

干预措施: Acetaminophen (Drug)

Epidural

Active Comparator

Patients will receive epidural analgesia (bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL + sufentanil 50 mcg/mL 1 mL) before general anesthesia for minor laparotomic liver resection.

干预措施: Ketorolac (Drug)

Epidural

Active Comparator

Patients will receive epidural analgesia (bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL + sufentanil 50 mcg/mL 1 mL) before general anesthesia for minor laparotomic liver resection.

干预措施: Ropivacaine (Drug)

Epidural

Active Comparator

Patients will receive epidural analgesia (bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL + sufentanil 50 mcg/mL 1 mL) before general anesthesia for minor laparotomic liver resection.

干预措施: Sufentanil (Drug)

结局指标

主要结局

Assessment of postoperative pain control by mean of the visual analog scale early after surgery

时间窗: Within 1 hour after surgery

Visual analog scale (VAS) will be assessed and compared between the two groups.

Assessment of postoperative pain control by mean of the visual analog scale one day after surgery

时间窗: 24 hours after surgery

Visual analog scale (VAS) will be assessed and compared between the two groups.

Assessment of postoperative pain control by mean of the visual analog scale six hours after surgery

时间窗: 6 hours after surgery

Visual analog scale (VAS) will be assessed and compared between the two groups.

Assessment of postoperative pain control by mean of the visual analog scale three days after surgery

时间窗: 72 hours after surgery

Visual analog scale (VAS) will be assessed and compared between the two groups.

Assessment of postoperative pain control by mean of the visual analog scale at hospital discharge

时间窗: Up to 30 days after surgery

Visual analog scale (VAS) will be assessed and compared between the two groups.

Assessment of postoperative pain control by mean of the visual analog scale two days after surgery

时间窗: 48 hours after surgery

Visual analog scale (VAS) will be assessed and compared between the two groups.

次要结局

  • Ready to discharge status(Up to 30 days after surgery)

研究者

发起方
Ospedale San Raffaele
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elena Bignami

M.D.

Ospedale San Raffaele

研究点 (1)

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