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临床试验/NCT04708353
NCT04708353Unknown不适用

Effect of Two Different Doses of Oral Pregabalin Premedication for Postoperative Pain Relief After Gynecological Surgeries

Zagazig University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年8月20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
入组人数
90
试验地点
1
主要终点
changes in Postoperative pain

研究概览

简要总结

Pain management after gynecological surgeries is essential for early mobilization of the patient, decrease postoperative complication and hospital stay. The use of opioids is associated with adverse effects such as nausea, vomiting, ileus, pruritus, sedation and respiratory depression.

Previous studies stated that pregabalin has been used to reduce pre-operative anxiety, acute postoperative pain, postoperative opioid requirements, postoperative nausea, vomiting and postoperative delirium. The most effective dose of pregabalin to relief postoperative pain with least side effect is still under trial.

In this study we will compare between two different doses of pregabalin when given as oral premedication in patients undergoing gynecological surgeries under spinal anesthesia regarding postoperative pain in order to reduce opioids consumption and subsequently avoid opioid-related adverse effects.

详细描述

Postoperative pain, nausea and vomiting continue to be one of the most common and unpleasant complications after surgery. The traditional pain treatment with opioids alone is not adequate any more. To optimize pain treatment and postoperative outcome, new analgesics and new combination of already existing analgesics are searched for.

Pain after gynecological surgery usually severe. Uncontrolled acute post-operative pain is associated with dissatisfaction, post-operative complications and considered as a strong risk factor for development of chronic pain. An enhanced recovery pathway for gynecological surgery must include a strategy to effectively control post-operative pain and allow attainment of other Enhanced Recovery After Surgery (ERAS) targets such as early mobilization and return to oral diet whilst reducing the need for opiates.

Beyond increasing the risk of developing opioid use disorder, perioperative opioid consumption may produce undesirable side effects such as nausea, vomiting, constipation, ileus, pruritus, altered mental status, urinary retention, respiratory complications and increased length of hospital stay. While many of these side effects are frustrating to patient in the immediate postoperative period, the most dangerous effects are those that affect the respiratory system such as opioid-induced respiratory depression (ORD) which consider as a significant cause of brain damage and death in the postoperative period.

Opioid reduction strategies prove useful for decreasing total opioid dose and, in turn, their associated adverse effects. Such strategies may include adjuvant non opioid analgesics such as α-2 agonists, gabapentinoids and N-methyl-D-aspartate receptor agonists as well as local, regional or neuraxial anesthesia and modification of surgical technique where possible for operative patients.

Pregabalin is a new synthetic molecule and a structural derivative of the inhibitory neurotransmitter gamma-amino butyric acid. It is a α2-δ ligand that has analgesic, anticonvulsant, anxiolytic and sleep-modulating activities. Pregabalin binds potently to the α2-δ subunit of calcium channels, resulting in a reduction in the release of several neurotransmitters including glutamate, noradrenaline, serotonin, dopamine and substance P.

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)

盲法说明

double-blinded ( patient and outcome assessors)

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Physical status: ASA I-II
  • BMI ≥ 20kg/m2 & ≤ 35kg/m2,
  • Written informed consent from the patient.

排除标准

  • Patients with known history of allergy to study drugs,
  • Patients on ACE inhibitors, anticonvulsant therapy or any drug interacting with pregabalin,
  • Patients on chronic alcohol, opioid, tranquilizer or sedative use,
  • Patient with renal impairment or heart failure,
  • Pregnant females, Psychological, mental disorders or depression,
  • Patients receiving anticoagulants therapy or suspected coagulopathy,
  • Patients already on pregbalin or gabapentin therapy.

研究组 & 干预措施

control group

Placebo Comparator

the patient will receive one placebo capsule (vitamin c) once one hour before the operation.

干预措施: placebo capsule (vitamin c) (Drug)

Group Pregabalin 150

Active Comparator

the patient will receive one capsule of pregabalin 150 mg once one hour before the operation

干预措施: Group pregabalin 150 (Drug)

Group Pregabalin 300

Active Comparator

the patient will receive one capsule of pregabalin 300 mg once one hour before the operation

干预措施: Group pregabalin 300 (Drug)

结局指标

主要结局

changes in Postoperative pain

时间窗: at 2, 4, 6, 8, 10, 12, 16, 20 and 24 hours postoperatively

will be assessed by visual analogue scale (VAS), On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.

次要结局

  • The level of sedation(at 2, 4, 6, 8, 10, 12, 16, 20 and 24 hours postoperatively)
  • Total amount of rescue analgesic(in the first 24 hours)

研究者

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

Asmaa Mohammed Galal El-Deen

lecturer of anesthesia and surgical intensive care

Zagazig University

研究点 (1)

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