跳至主要内容
临床试验/CTRI/2025/11/097884
CTRI/2025/11/097884
尚未招募
4 期

Evaluation of efficacy of low dose ketamine in relieving intraoperative post child birth pain in lower segment caesarean section: a prospective, randomised, double-blind case control study

Maharana Bhupal Government Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年12月10日最近更新:

概览

阶段
4 期
状态
尚未招募
发起方
Maharana Bhupal Government Hospital
入组人数
80
试验地点
1
主要终点
To Evaluate the intra operative pain relief achieved for the patient on giving 0.5 mg/kg of Ketamine intravenously following child delivery

概览

简要总结

­­­­A reasonable proportion of parturients undergo Caesarean delivery, due to varied indications. A good fraction of the caesarean deliveries takes place under the subarachnoid/spinal anaesthesia. This anaesthesia is considered the gold standard because it allows the woman to see the newborn intraoperatively, can provide good postoperative analgesia, and obviates need for airway manipulation. A potentially devastating complication of spinal anaesthesia for Caesarean Delivery is intraoperative pain also described as Pain during caesarean delivery (PDCD). The incidence of intra operative pain is around 11.9% in the population undergoing the surgery.Intraoperative pain can cause long term psychological and physical consequences. Significant pain during caesarean may affect the patient experience and has been associated as an independent risk factor for postpartum post-traumatic stress disorder. Pain associated with caesarean section may occur before the delivery of baby, after delivery of baby or may be present throughout the procedure. Preoperative anxiety may contribute to a pain sensation in initial duration of the procedure. Pain following child birth can be attributed to the use of oxytocin, uterus exteriorization, peritoneal or mesenteric pull, amniotic fluid embolism. Parturient may experience different types of pain and discomfort following birth, including cramping pain (often called after-birth pain) associated with uterine involution, where the uterus contracts to reduce blood loss and return the uterus to its non pregnant size.

Ketamine is an N-methyl-d-aspartate (NMDA) receptor inhibitor that causes analgesia by desensitization of stimulated N-methyl-d-aspartate receptor, thereby blocking pain signal in central nervous system. . Ketamine has a minimal effect on the central respiratory drive if given slowly, although rapid iv injection can cause transient apnoea. Ketamine may provoke imaginative, dissociative states and psychotic symptoms resembling schizophrenia due to its NMDA-antagonistic action, as well as severely impairing semantic and episodic memory. Subanaesthetic doses of ketamine prevent central sensitization, development of acute opioid tolerance, and hyperalgesia. Low-dose ketamine also decline the activity of brain structures that respond to noxious stimuli. It has effects on opioid receptors and stimulates monoaminergic descending inhibitory pathways at supraspinal sites causing in antinociception, all of which mediate analgesic effects. Ketamine is used increasingly in sub-anaesthetic doses as an adjuvant to local anaesthetics and opioids in multimodal pain therapy for acute pain management.

The study aims at evaluation of the effect of intraoperative Ketamine administration in relieving the pain during caesarean section, as well as post operatively.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Parturients with Singleton pregnancy (37-42 weeks) Elective LSCS ASA Grade II.

排除标准

  • Patient Refusal Non cooperative Parturients Patients with medical comorbidities like, cardiac diseases such as inadequate left ventricular ejection fraction (Ejection Fraction less than 45%), valvular or ischaemic heart disease, uncontrolled hypertension, heart blocks, arrhythmia, cardiac failure, uncontrolled diabetes mellitus, hepatic, renal, endocrine, haematological, autoimmune, psychiatric, neurological diseases, neuromuscular diseases, bronchial asthma, chronic obstructive pulmonary disease. Allergy to study drug.
  • Ketamine Patients who participated in another study within 30 days.

结局指标

主要结局

To Evaluate the intra operative pain relief achieved for the patient on giving 0.5 mg/kg of Ketamine intravenously following child delivery

时间窗: After childbirth at 0,2,5,10,15,20,30 mins intraoperatively and at End of surgery

次要结局

  • To evaluate the post operative analgesic effect of low dose ketamine(At 2,6 ,12 and 24 hours post operatively.)
  • To look for any adverse effects/complications associated with administration of ketamine

研究者

发起方
Maharana Bhupal Government Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Hemraj Tungria

RNT Medical College

研究点 (1)

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