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临床试验/NCT03060265
NCT03060265Unknown不适用

Protective Analgesia in Caesarean Section Using Intravenous Paracetamol: A Prospective Randomised Controlled Trial

Bnai Zion Medical Center0 个研究点目标入组 60 人开始时间: 2017年3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
入组人数
60
主要终点
The pain intensity level

研究概览

简要总结

Protective analgesia in caesarean section using intravenous paracetamol: A prospective randomised controlled trial. Cesarean section a common surgical procedure in women. The parturients undergoing CS experience severe to moderate postoperative pain. Pain relief is very important to the patient as it causes discomfort which affects hemodynamic intraoperative and increases the risk of postoperative complications. Analgesia is crucial to postoperative recovery.

Aims: To investigate the efficacy of combined administration of paracetamol, as protective multimodal analgesia, and standard spinal anesthesia in the reduction of postoperative pain following cesarean section.

Sixty adult Parturients undergoing CS will participate in a single-centered, randomized, double-blinded, placebo-controlled trial divided into 2 groups 30 each. The intervention group will receive 1 gr of intravenous paracetamol in 100 ml normal saline only 15 minutes prior to spinal anesthesia induction. The control group will receive 100 ml normal saline IV identical in size and shape and manner to the experimental group, 15 minutes prior to induction of spinal anesthesia. We will measure postoperative Visual Analog Scale (VAS) pain score, postoperative time to analgesia in PACU and number of postoperative analgesic doses within 24 hours.

详细描述

Cesarean section (CS) is one of most common surgical procedure in women. Parturients undergoing CS, experience severe to moderate postoperative pain. Pain after CS may impair the ability of mother to care and feed her child, early ambulation, and discharge. About 12.3% of parturients experience pain scores enough to affect infant care up to 6 months after CS.

All of perioperative stress effects, before delivery of the baby, such as, skin incision, need various approaches of treatment, which may include systemic and neuraxial analgesia.

Surgical trauma causes immediate changes in both peripheral and central nervous systems, leading to augmentation of pain perception in the final destination - the cerebral cortex. The surgical incision induces secretion of cyclooxygenase-2 (COX-2), which increases the production of prostaglandins (PGs), and which in turn excites peripheral nociceptors. These special pain fibers not only transmit the pain signal to the central nervous system, but also amplify tissue sensitivity to the surgical trauma, giving rise to the phenomenon known as "local hyperalgesia".

Improper pain control during the perioperative period leads to complications, which may affect the outcome of CS. Pain relief is very important to the patient as the pain causes discomfort which affects hemodynamic intraoperative and increases the risk of postoperative complications as atelectasis, ineffective, coughing and inadequate ventilation. Adequate pain control is essential not only intraoperatively, but also in immediate postoperative period to cover long time period postoperatively. The major role of intra- or post-operative management of pain is to reduce the dose of medication and to lessen side-effects, while providing adequate analgesia. This role may best be accomplished with multimodal protective analgesia or preemptive analgesia. Protective multimodal analgesia term is described as any intraoperative analgesic agents able to control pain-induced sensitization of the central nervous system. Preemptive analgesia had been defined as an antinociceptive treatment, starts before surgery that to prevent establishment of altered central afferent input from injuries and its goal is to decrease pain by timing the analgesic's peak pharmacodynamic effect with anticipated onset of pain or peak pain response.

Protective analgesia is distinguished from pre-emptive analgesia in that it focuses less on the treatment and on the relatively timing and the anesthetic intervention but rather more on the mechanisms of action. Protective analgesia aims to decrease the impact of the nociceptive barrage associated with noxious pre-operative, intra-operative, and/or post-operative events/stimuli.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Parturient age between 18 and 40 years,
  • A maximal American Society of Anesthesiologists (ASA) Score of II,
  • Parturients undergoing first elective cesarean section.

排除标准

  • Current or previous chronic NSAID or opioid treatment, liver or renal insufficiency, asthma, cardiovascular disease, allergy to paracetamol or other NSAIDs.
  • Parturients with ASA III, IV and whom spinal anesthesia failure will be also excluded from the study.

研究组 & 干预措施

Paracetamol

Active Comparator

Paracetamol Braun Germany 1 gram in 100ml normal saline, one dose IV

干预措施: Paracetamol (Drug)

Placebo

Placebo Comparator

100ml normal saline, one dose IV

干预措施: PLACEBO (Drug)

结局指标

主要结局

The pain intensity level

时间窗: 24 hours

measured by VAS score The pain intensity level presented in VAS scale (0- none, 10-the worst imaginable pain) will be estimated and marked at arrival in PACU ,2, 4, 8, 12 and 24 hours postoperatively will be estimated.

次要结局

  • side effects(24 hours)
  • Postoperative time to administration of first analgesic dose (Time-to-Analgesia; TTA).(24 hours)
  • Number of analgesic doses administered in the first 24 hours after surgery.(24 hours)

研究者

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

MOSTAFA.SOMRI

Director of Anesthesia Department

Bnai Zion Medical Center

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