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临床试验/CTRI/2019/02/017467
CTRI/2019/02/017467尚未招募不适用

COMPARISON OF KETAMINE, LEVOBUPIVACAINE AND A COMBINATION OF BOTH AS PRE-INCISION SURGICAL SITE INFILTRATION FOR POSTOPERATIVE ANALGESIA AFTER ABDOMINAL HYSTERECTOMY

Vardhman Mahavir Medical College and Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
cumulative pethidine requirement in 24 h

研究概览

简要总结

Using a computer-generated random number table, patients will be allocated randomly into one of the three study groups:

Group K:  Patients will receive ketamine 1 mg/kg in saline, total volume 20 ml as subcutaneous infiltration, in and around the incision line as a rectangle, 5 min before skin incision.

Group L:  Patients will receive levobupivacaine 0.25%, total volume 20 ml as subcutaneous infiltration, in and around the incision line as a rectangle, 5 min before skin incision.

Group KL: Patients will receive ketamine 1 mg/kg in levobupivacaine 0.25%, total volume 20 ml as subcutaneous infiltration, in and around the incision line as a rectangle, 5 min before skin incision.

Group assignments will be concealed within opaque envelopes.

PROCEDURE

In the operating room, monitors (electrocardiogram, noninvasive blood pressure, pulse oximeter) will be applied and baseline readings noted. Anaesthesia will be induced with midazolam (1mg), fentanyl (2 µg/kg), propofol 10% (2 mg/kg) followed by vecuronium bromide (0.1 mg/kg) for facilitating insertion of Pro Seal laryngeal mask airway (PLMA).  Anaesthesia will be maintained on oxygen and nitrous oxide (33:66) in isoflurane. Fentanyl (1µg/kg) bolus dose will be given at completion of one hour of anaesthesia induction, for meeting intraoperative analgesic requirement.

Under strict aseptic precautions, after cleaning and draping the patient, the study drug will be infiltrated subcutaneously, in and around the incision line as a rectangle by the operating surgeon. The surgical incision will be given after 5 min have elapsed from the time of study drug administration. Approximately 30 min before the end of surgical procedure, 1 g paracetamol will be given intravenously over 15 min and 4mg ondansetron will be given intravenously over 5 min. At the end of surgery, volatile anaesthetics will be discontinued, residual neuromuscular block will be antagonized with neostigmine 0.05 mg/kg and glycopyrrolate 0.01 mg/kg and the PLMA will be removed when the patient is fully conscious.

Postoperatively, all patients will receive 1 g paracetamol intravenously 8 hourly for pain relief. If VAS score is ≥ 4, pethidine 0.4 mg/kg will be given intravenously, if the VAS score did not decrease within 10 more min, pethidine 0.2 mg/kg will be given to the patient with maximum dose of 1 mg/kg in any 4 h. The total pethidine consumption and time to the first additional pethidine need will be recorded. Finally, occurrence of adverse effects such as nausea, vomiting, sedation and hallucinations will be noted and treated accordingly.

Following parameters will be noted on arrival of patient in the PACU at 0, 15 and 30 min, and at 1, 2, 6, 12, and 24 h postoperatively:

Haemodynamic parameters and respiratory rate (RR)

Severity of pain at rest and on movement using Visual Analogue Scale score (VAS) where 0 indicates no pain, and 10 is worst pain possible.

Time to first pethidine requirement and cumulative pethidine requirement in 1, 2, 6, 12 and 24 h time frame.

Occurrence of side effects such as nausea, vomiting, sedation, hallucinations.

Occurrence and severity of nausea will be noted. Nausea severity will be graded as none/mild /moderate/severe. Retching will be considered as vomiting for statistical purpose.

Level of sedation will be assessed using a 4-point scale (0 = awake and alert, 1 = minimally sedated, responds to speech, 2 = moderately sedated, arousable by tactile stimulation, and 3 = deeply sedated, arousable only by painful stimulation).

Patient satisfaction from postoperative analgesia will be assessed at 24 h postoperatively using a 5-point scale (1 = very unsatisfied, 2 = unsatisfied, 3 = fair, 4 = satisfied, and 5 = very satisfied).

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
Female

入选标准

  • Patients fulfilling the American society of Anaesthesiologists (ASA) physical status I or II criteria,age from 18years to 75years,Duration of surgery less than 2 hours.

排除标准

  • Patients with allergy to study drugs,cardiovascular disease (such as hypertension, tachycardia, arrhythmia, congestive heart failure, and coronary artery disease,Psychiatric disorder,Neurological disease, increased intracranial pressure, seizure disorder, glaucoma, hyperthyroidism 5.Liver or renal dysfunction.

结局指标

主要结局

cumulative pethidine requirement in 24 h

时间窗: 24 h after surgery

次要结局

  • Time to first pethidine requirement(0 to 24h)
  • cumulative pethidine requirement in 1, 2, 6, and 12 h time frame(1, 2, 6, and 12 h after surgery)
  • Pain scores at rest and on movement postoperatively at 0, 15 and 30 min and at 1, 2, 6, 12, and 24 h(0, 15 and 30 min and at 1, 2, 6, 12, and 24 h after surgery)
  • Occurrence of side effects such as nausea, vomiting, sedation and hallucinations(0 to 24h)
  • Patient satisfaction regarding postoperative analgesia at 24 h(24h after surgery)

研究者

发起方
Vardhman Mahavir Medical College and Safdarjung Hospital
申办方类型
Government medical college

研究点 (1)

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