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临床试验/NCT02515422
NCT02515422已完成1 期

Subcutaneous Wound Infiltration of Ketamine is Superior to Bupivacaine in Terms of Pain Perception and Opioid Consumption After Cesarean Section: a Double-blinded Randomized Placebo Controlled Clinical Trial.

Huseyin Aksoy1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
Huseyin Aksoy
入组人数
120
试验地点
1
主要终点
Postoperative visual analog scale pain score

研究概览

简要总结

Aim: To assess the analgesic efficacy of subcutaneous infiltration of ketamine, either alone or as an adjuvant to bupivacaine, following CS and to compare their effects on postoperative pain scores and opioid consumption.

Methods: Included patients were allocated to four treatment groups using computer-generated randomization number chart as follows; Group 1 (Ketamine, n=30) received subcutaneous infiltration of ketamine, Group 2 (Bupivacaine, n=30) received subcutaneous infiltration of bupivacaine 0.5%, Group 3 (Ketamine+Bupivacaine, n=30) received subcutaneous infiltration of ketamine+bupivacaine 0.5% and Group 4 (Placebo, n=30) received subcutaneous infiltration of placebo (0.9% saline solution). Patients, anesthetist, surgeon, and other medical and nursing staff were blinded to the contents of the medications. VAS scores at resting and on coughing and analgesic consumptions were compared.

详细描述

the Group 1 (Ketamine, n=30) received subcutaneous infiltration of ketamine 1 mg/kg (Ketalar®, 10 mL inj., 50 mg ketamine hydrochloride/ml, Pfizer Drug Company, USA). The Group 2 (Bupivacaine, n=30) received subcutaneous infiltration of 20 mL (100 mg) of bupivacaine 0.5% (Marcaine®, 20 mL inj. 5 mg bupivacaine hydrochloride/ml, AstraZeneca Drug Company, Turkey). The Group 3 (Ketamine+Bupivacaine, n=30) received subcutaneous infiltration of ketamine 1 mg/kg (Ketalar®) plus subcutaneous infiltration of 20 mL (100 mg) of bupivacaine 0.5% (Marcaine®). The Group 4 (Placebo, n=30) received subcutaneous infiltration of 30 mL placebo (0.9% saline solution). All medications were diluted with sterile 0.9% saline solution to 30 ml solutions in the similar volume and shape syringes and were infiltrated subcutaneously along the skin wound edges and close to the fascia prior to skin closure. There were four separate syringes which were prepared by an anesthesiology technician for four different treatment groups labeled G1, G2, G3 and G4 containing the ketamine, bupivacaine, ketamine plus bupivacaine and normal saline solution. Patients, anesthetist, surgeon, and other medical and nursing staff were blinded to the contents of the medications.

研究设计

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

入排标准

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

入选标准

  • singleton term pregnancy,
  • between 38-41th weeks of gestation,
  • absence of any medical or obstetrical problems.

排除标准

  • multiple pregnancies,
  • intrauterine fetal deaths,
  • active stage of labor,
  • obstetric emergencies such as antepartum hemorrhage, eclampsia and acute fetal distress,
  • special request for general anesthesia,
  • history of allergic reaction or sensitivity to any of the drugs used in the study,
  • reflected anxiety and depression during the cesarean operation,
  • any systemic diseases (chronic hypertension, thyroid diseases, renal or hepatic insufficiency, psychiatric disorders,
  • chronic pain syndrome, epilepsy or intracranial hypertension)
  • medications that would affect the perception of pain,
  • current or past history of narcotic use or a history of narcotic abuse,
  • inability to understand how to score a 10-cm visual analogue scale (VAS) for pain.

研究组 & 干预措施

Group 1, Ketamine

Active Comparator

Ketamine, 1 mg/kg (Ketalar®, 10 mL inj., 50 mg ketamine hydrochloride/ml, Pfizer Drug Company, USA) was administered subcutaneously before the closure of pfannenstiel incision.

干预措施: Ketamine (Drug)

Group 2, Bupivacaine

Active Comparator

Bupivacaine 0.5% 20 mL (100 mg) (Marcaine®, 20 mL inj. 5 mg bupivacaine hydrochloride/ml, AstraZeneca Drug Company, Turkey) was administered subcutaneously before the closure of pfannenstiel incision.

干预措施: Bupivacaine (Drug)

Group 3, Ketamine+Bupivacaine

Active Comparator

Ketamine 1 mg/kg (Ketalar®) and bupivacaine 0.5% (100 mg) (Marcaine®) were administered subcutaneously before the closure of pfannenstiel incision.

干预措施: Ketamine (Drug)

Group 3, Ketamine+Bupivacaine

Active Comparator

Ketamine 1 mg/kg (Ketalar®) and bupivacaine 0.5% (100 mg) (Marcaine®) were administered subcutaneously before the closure of pfannenstiel incision.

干预措施: Bupivacaine (Drug)

Group 4, Placebo

Placebo Comparator

Placebo (0.9% saline solution) was administered subcutaneously before the closure of pfannenstiel incision.

干预措施: Placebo (0.9% saline solution) (Drug)

结局指标

主要结局

Postoperative visual analog scale pain score

时间窗: Postoperative 12 hours

次要结局

  • Postoperative opioid consumption(Postoperative 12 hours)

研究者

发起方
Huseyin Aksoy
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Huseyin Aksoy

M.D.

Kayseri Education and Research Hospital

研究点 (1)

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