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临床试验/NCT05455944
NCT05455944已完成不适用

Analgesic Efficacy of Pre-operative Oral Pregabalin in Dacryocystorhinostomy Surgery

Sameh Fathy1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Sameh Fathy
入组人数
100
试验地点
1
主要终点
Changes in pain scores by visual analogue scale (VAS)

研究概览

简要总结

This study is conducted to evaluate the effects of preoperative oral pregabalin on postoperative pain and analgesic requirements in patients undergoing DCR surgery. The primary outcome is to compare pain scores by visual analogue scale (VAS). Secondary outcomes are the time of first analgesic request, the total analgesic requirements during the postoperative 24 hours, the incidence of PONV, in addition to effect on hemodynamic parameters between the two groups.

详细描述

External dacryocystorhinostomy (DCR) is still considered the golden standard for lacrimal surgery. It is a bypass technique which creates an anastomosis between the lacrimal sac and the nasal mucosa through a bony ostium via an external skin incision. External DCR can be completed under either local or general anesthesia. It is a painful surgical procedure that involves intra- and extra-ocular dissection, with a high prevalence post-operative nausea and vomiting (PONV). So, it is necessary to ensure a stress-free peri-operative period with adequate pain relief and a low incidence of PONV after DCR surgery.

Pregabalin is a lipophilic gamma-amino-butyric acid (GABA) analogue that binds to the voltage-gated calcium channels. It reduces the excitability of the dorsal horn neurons after tissue damage. It has anticonvulsant, anxiolytic and sleep-modulating properties. It was shown to be effective in several models of neuropathic pain, incisional injury, and inflammatory injury.

Preoperative administration of pregabalin is supposed to be a promising technique of enhancing postoperative pain control and reduction in postoperative opioid consumption.

This study is a prospective randomized double-blind clinical trial included 100 ASA I and II patients of both sex with age between 18 and 65 years old, who are planned for elective DCR surgery under general anesthesia in Mansoura University ophthalmology center. Informed written consent is obtained from all subjects in the study after ensuring confidentiality. Details of the anesthetic technique and the study protocol are clarified to the entire involved cases. Patients are randomly assigned to two equal groups according to computer-generated randomization schedule.

A prospective analysis of the collected data is performed using the Statistical Package for the Social Sciences (SPSS) program for Windows (version 22). All data are considered statistically significant if P value is ≤ 0.05.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiology (ASA) I and II patients.
  • Scheduled for DCR surgery.

排除标准

  • Patient' refusal of consent.
  • Mental, psychological or neurological disorders.
  • Patients with history of drug or alcohol abuse.
  • History of know sensitivity to the used drugs.
  • Bleeding or coagulation diathesis.
  • Obese patients (body mass index (BMI) < 35).
  • Pregnancy and lactation.

研究组 & 干预措施

Control Group

Placebo Comparator

Patients received two capsules: one at the night of surgery, and the other at 2 hours before the surgery

干预措施: Placebo (Drug)

Pregabalin Group

Active Comparator

Patients received two capsules: one at the night of surgery, and the other at 2 hours before the surgery

干预措施: Pregabalin 150mg (Drug)

结局指标

主要结局

Changes in pain scores by visual analogue scale (VAS)

时间窗: Up to 24 hours after the procedure

Pain (VAS) score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain)

次要结局

  • Changes in heart rate(Up to the end of the surgery)
  • Changes in mean arterial blood pressure(Up to the end of the surgery)
  • First analgesic request(Up to 24 hours after the procedure)
  • Total analgesic requirements of pethidine(Up to 24 hours after the procedure)
  • Incidence of postoperative nausea and vomiting(Up to 24 hours after the procedure)

研究者

发起方
Sameh Fathy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sameh Fathy

Lecturer of anesthesia, ICU & pain management - Faculty of Medicine

Mansoura University

研究点 (1)

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