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临床试验/NCT01247857
NCT01247857已完成3 期

Double Blind Randomized Phase III Controlled Trial Comparing the Effect of Preoperative and Postoperative Nebulization of Ropivacaine on Pain Control After Laparoscopic Cholecystectomy

San Gerardo Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Postoperative Pain

研究概览

简要总结

Intraperitoneal nebulization of local anesthetic is a novel approach to pain management after laparoscopy. Preoperative compared with postoperative administration of analgesia remains controversial. This randomized, double blind, placebo-controlled trial compared the analgesic efficacy of preoperative with postoperative peritoneal ropivacaine nebulization in patients undergoing elective laparoscopic cholecystectomy.

详细描述

Previous studies evaluating intraperitoneal local anesthetic administration for pain relief after laparoscopic surgery have suggested that the timing of local anesthetic administration may be critical in the success of the technique. A meta-analysis of randomized trials of intraperitoneal local anesthetic instillation in patients undergoing laparoscopic surgery found that local anesthetic instilled before surgical dissection provided superior pain relief compared to instillation at the end of surgery. Intraperitoneal nebulization of local anesthetic is a novel approach to pain management after laparoscopic surgery. Recently, Alkhamesi et al reported that bupivacaine nebulization performed at the end of laparoscopic cholecystectomy significantly reduced postoperative pain. However, clinical benefits of preoperative administration of analgesia, compared with postoperative administration, remains controversial.

The investigators hypothesized that pain relief after preoperative and postoperative ropivacaine nebulization would be similar but better than placebo.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA Score I-III
  • Scheduled for laparoscopic cholecystectomy
  • Free from pain in preoperative period
  • Not using analgesic drugs before surgery
  • Without cognitive impairment or mental retardation
  • Written informed consent

排除标准

  • Emergency/urgency surgery
  • Postoperative admission in an intensive care unit
  • Cognitive impairment or mental retardation
  • Progressive degenerative diseases of the CNS
  • Seizures or chronic therapy with antiepileptic drugs
  • Severe hepatic or renal impairment
  • Pregnancy or lactation
  • Allergy to one of the specific drugs under study
  • Acute infection or inflammatory chronic disease
  • Alcohol or drug addiction

研究组 & 干预措施

Preoperative Nebulization

Active Comparator

Nebulization of 30 mg of Ropivacaine in the peritoneal cavity before surgery

干预措施: Ropivacaine 30 mg (Drug)

Postoperative Nebulization

Active Comparator

Nebulization of 30 mg of Ropivacaine in the peritoneal cavity after surgery

干预措施: Ropivacaine 30 mg (Drug)

Control

Placebo Comparator

Nebulization of normal saline 3 ml before and after surgery

干预措施: Saline (Drug)

结局指标

主要结局

Postoperative Pain

时间窗: 48 hours

Postoperative pain will be assessed by numeric ranking scale (NRS 0 to 10 points) at rest (static NRS) and after a deep inspiration or cough (dynamic NRS). The proportion of patients with adequate pain control after surgery (dynamic NRS \< 3) will also be assessed.

次要结局

  • Time of unassisted walking(Up to 48 hours)
  • Morphine consumption (mg)(Up to 48 hours)
  • Hospital morbidity(Up to 48 hours)
  • Time to hospital discharge(48 hours)

研究者

发起方
San Gerardo Hospital
申办方类型
Other

研究点 (1)

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