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临床试验/NCT04862845
NCT04862845已完成1 期

Effect of Combination of Duloxetine and Pregabalin to Improve Pain After Liposuction Surgery

Cairo University0 个研究点目标入组 90 人开始时间: 2021年7月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
90
主要终点
total morphine consumption by( mg ) over 5 day

研究概览

简要总结

Postoperative pain is mediated by different mechanisms at multiple neural sites. Thus, multimodal analgesics can reduce the postoperative pain. Although Opioids are considered the analgesics of choice to treat moderate to severe pain, their use carries the risk of side effects and hyperalgesia. Multimodal analgesia can be achieved by combining different analgesics and different methods of administration, to provide better analgesia synergistically compared with conventional analgesia. Therefore,lower doses for each drug can be provided with fewer overall side-effects obtained from individual compounds.

Recently, antidepressants such as duloxetine, a selective serotonin and norepinephrine reuptake inhibitor (SSNRI), have accomplished pain relief in persistent and chronic pain as in fibromyalgia, postherpetic neuralgia, diabetic neuropathy, osteoarthritis and musculoskeletal pain. The analgesic effect of duloxetine is attributed to its ability to enhance both serotonin and norepinephrine neurotransmission in descending inhibitory pain pathways. Moreover, some studies have promoted its use to improve the quality of recovery after surgery and reduce the acute postoperative pain after knee replacement surgery , mastectomy , hysterectomy , and after spine surgery. In addition it can improve postoperative quality of recovery through mood improvement that can be helpful in the postoperative period.

The main objective of the present study was to examine perioperativelythe analgesic efficacy with the combination of duloxetine and prgabalinon postoperative pain when given as part of a multimodal pain strategy in patients undergoing surgery on liosuction. In addition to evaluating the patient's satisfaction and the adverse effects related to the combination of both medications.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged from 18 to40 years.
  • ASA I-II.
  • undergoing elective mega -liposuction surgery
  • BMI from 18 to 50 kg/m2

排除标准

  • Patient refusal
  • Contraindication or chronic use (consistent use for longer than 3 months) to any of the study drugs ASA III-IV.
  • Patients aged less than 18 or more than
  • Body mass index >
  • Suffered from severe psychiatric disease or drug addiction;
  • Chronic opioid consumption,
  • a history of regular sedatives or anticonvulsants intake, serious organ disease or dysfunction
  • inability to use a PCA device
  • History of parenteral or oral analgesic intake within the last 48hours.

研究组 & 干预措施

Patients in group I (PD group)

Active Comparator

干预措施: Duloxetine and Pregabalin (Drug)

patients in group II (P group)

Active Comparator

干预措施: pregabalin (Drug)

patients in group III (C groups)

Sham Comparator

干预措施: sham (Drug)

结局指标

主要结局

total morphine consumption by( mg ) over 5 day

时间窗: 5 days

Postoperative morphine consumption mg

次要结局

  • Postoperative pain score(24 hous)
  • total intraoperative fentanyl consumption (microgram) during surgery(24 hous)
  • time to 1st request of rescue analgesia.(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr Samir Wahdan

Assistant Professor of anesthesia, SICU & and pain management

Cairo University

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