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临床试验/NCT02327923
NCT02327923已完成4 期

Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy: a Randomized Clinical Trial

B.P. Koirala Institute of Health Sciences1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
90
试验地点
1
主要终点
Opioid (morphine equivalent) requirement in the first 24 h postoperatively

研究概览

简要总结

Comparison of intraoperative infusion of lidocaine and esmolol in the postoperative requirement of opioid for postoperative pain management after laparoscopic cholecystectomy to decrease opioid related side effects and enhance postoperative recovery with multimodal analgesia approach.

详细描述

Postoperative pain after abdominal surgery includes many forms of distress, such as spontaneous pain at rest; pain during movement, including that of respiration; and visceral pain arising from damage to internal organs during surgery. Acute pain after laparoscopic cholecystectomy is complex in nature. The pain pattern does not resemble pain after other laparoscopic procedures, suggesting that analgesic treatment might be procedure specific and multimodal. Three components have been described: incisional pain as dominant, visceral deep pain, and shoulder referred pain. Opioids are most commonly used for postoperative analgesia in laparoscopic cholecystectomy. However, they can be associated with many side effects and delayed discharge. In addition, opioids do not offer the quality of postoperative pain relief that one would expect, probably because of the pain specific to laparoscopic cholecystectomy. A single agent is unlikely to treat all three types of pain. Therefore a multimodal approach will be required.

Low-dose IV lidocaine is easy to administer, has well-established analgesic, anti-hyperalgesic, and anti-inflammatory effects, and has minimal toxicity in commonly studied doses (typically 1.5-3 mg/kg/h). Because postoperative pain is to a large extent an inflammatory phenomenon, administration of systemic local anesthetics, which have inflammatory modulatory properties, could significantly reduce pain and therefore allow more rapid discharge. Lidocaine has an excellent safety record when administered by low-dose infusion. In addition, intravenous lidocaine is an effective modality for treating visceral pain.

Esmolol has been proposed as an alternative to intraoperative use of opioids, and found to facilitate the fast-tracking process and speed home-readiness of patients undergoing outpatient surgery. The various mechanisms of opioids dose sparing with concomitant use of β-adrenergic antagonist have been proposed from time to time such as suppression of stress hormones and pro-inflammatory cytokines, alteration of hepatic drug metabolism, activation of G-coupled proteins in cell membrane, central analgesia and so on but nothing conclusive has been established as yet.

After pre operative evaluation, patients will be premedicated with oral diazepam (0.1-0.2 mg/kg) at the night before and 2 hours before surgery. Informed consent will be obtained from all patients. Patients will be instructed during pre-anaesthetic visit about the use of the visual analogue scale (0-10 cm) where 0 is no pain and 10 is worst imaginable excruciating pain. They will also be informed that they will be asked their pain (VAS score) with its character during first 24 hrs after the surgery.

Both the patient and the investigator observing the outcome will be blinded about assignment of patient group during the study. The investigator will not enter the operating room but will be responsible for data collection in post operative period and data analysis. On arrival of patients in the preoperative holding area, they will be randomly assigned into any of two groups using computer generated random number. Details of group assignment and case number will be kept in a set of sealed opaque envelope. The anesthesia staff will open the envelope and prepare drugs accordingly. The attending anesthesiologist will not be involved in the data collection and analysis, and will follow the standard general anaesthesia protocol during the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Adult female patients of ASA physical status I or II, between age of 18 to 60 years undergoing elective laparoscopic cholecystectomy under general anaesthesia.

排除标准

  • Refusal to give consent.
  • ASA physical status III or more.
  • Inability to comprehend pain assessment score or severe mental impairment.
  • Difficult intubation.
  • Pregnancy.
  • Morbid obesity.
  • History of epilepsy.
  • History of allergy to any drug used in the study.
  • History of ongoing use of opioids or beta adrenergic receptor antagonists.
  • Baseline heart rate less than 50 beats per minute.
  • Presence of pain immediately before surgery.
  • Chronic pain other than gall stone disease.
  • Gastrointestinal ulceration, bleeding disorder.
  • Peritonitis (including previous), perforated gall bladder, severe acute cholecystitis, known to have choledocholithiasis.

研究组 & 干预措施

Lidocaine

Active Comparator

Intravenous bolus administration of lidocaine at the time of induction followed by infusion till the last suture.

干预措施: Lidocaine (Drug)

Lidocaine

Active Comparator

Intravenous bolus administration of lidocaine at the time of induction followed by infusion till the last suture.

干预措施: Paracetamol (Drug)

Lidocaine

Active Comparator

Intravenous bolus administration of lidocaine at the time of induction followed by infusion till the last suture.

干预措施: Propofol (Drug)

Lidocaine

Active Comparator

Intravenous bolus administration of lidocaine at the time of induction followed by infusion till the last suture.

干预措施: Fentanyl (Drug)

Lidocaine

Active Comparator

Intravenous bolus administration of lidocaine at the time of induction followed by infusion till the last suture.

干预措施: Vecuronium (Drug)

Lidocaine

Active Comparator

Intravenous bolus administration of lidocaine at the time of induction followed by infusion till the last suture.

干预措施: Ondansetron (Drug)

Lidocaine

Active Comparator

Intravenous bolus administration of lidocaine at the time of induction followed by infusion till the last suture.

干预措施: Bupivacaine (Drug)

Lidocaine

Active Comparator

Intravenous bolus administration of lidocaine at the time of induction followed by infusion till the last suture.

干预措施: Atropine (Drug)

Lidocaine

Active Comparator

Intravenous bolus administration of lidocaine at the time of induction followed by infusion till the last suture.

干预措施: Ephedrine (Drug)

Lidocaine

Active Comparator

Intravenous bolus administration of lidocaine at the time of induction followed by infusion till the last suture.

干预措施: Morphine (Drug)

Lidocaine

Active Comparator

Intravenous bolus administration of lidocaine at the time of induction followed by infusion till the last suture.

干预措施: Ketorolac (Drug)

Lidocaine

Active Comparator

Intravenous bolus administration of lidocaine at the time of induction followed by infusion till the last suture.

干预措施: Tramadol (Drug)

Lidocaine

Active Comparator

Intravenous bolus administration of lidocaine at the time of induction followed by infusion till the last suture.

干预措施: Neostigmine (Drug)

Lidocaine

Active Comparator

Intravenous bolus administration of lidocaine at the time of induction followed by infusion till the last suture.

干预措施: Glycopyrrolate (Drug)

Esmolol

Active Comparator

Intravenous bolus administration of esmolol at the time of induction followed by infusion till the last suture.

干预措施: Esmolol (Drug)

Esmolol

Active Comparator

Intravenous bolus administration of esmolol at the time of induction followed by infusion till the last suture.

干预措施: Paracetamol (Drug)

Esmolol

Active Comparator

Intravenous bolus administration of esmolol at the time of induction followed by infusion till the last suture.

干预措施: Lidocaine (Drug)

Esmolol

Active Comparator

Intravenous bolus administration of esmolol at the time of induction followed by infusion till the last suture.

干预措施: Propofol (Drug)

Esmolol

Active Comparator

Intravenous bolus administration of esmolol at the time of induction followed by infusion till the last suture.

干预措施: Fentanyl (Drug)

Esmolol

Active Comparator

Intravenous bolus administration of esmolol at the time of induction followed by infusion till the last suture.

干预措施: Vecuronium (Drug)

Esmolol

Active Comparator

Intravenous bolus administration of esmolol at the time of induction followed by infusion till the last suture.

干预措施: Atropine (Drug)

Esmolol

Active Comparator

Intravenous bolus administration of esmolol at the time of induction followed by infusion till the last suture.

干预措施: Ephedrine (Drug)

Esmolol

Active Comparator

Intravenous bolus administration of esmolol at the time of induction followed by infusion till the last suture.

干预措施: Morphine (Drug)

Esmolol

Active Comparator

Intravenous bolus administration of esmolol at the time of induction followed by infusion till the last suture.

干预措施: Ketorolac (Drug)

Esmolol

Active Comparator

Intravenous bolus administration of esmolol at the time of induction followed by infusion till the last suture.

干预措施: Ondansetron (Drug)

Esmolol

Active Comparator

Intravenous bolus administration of esmolol at the time of induction followed by infusion till the last suture.

干预措施: Bupivacaine (Drug)

Esmolol

Active Comparator

Intravenous bolus administration of esmolol at the time of induction followed by infusion till the last suture.

干预措施: Tramadol (Drug)

Esmolol

Active Comparator

Intravenous bolus administration of esmolol at the time of induction followed by infusion till the last suture.

干预措施: Neostigmine (Drug)

Esmolol

Active Comparator

Intravenous bolus administration of esmolol at the time of induction followed by infusion till the last suture.

干预措施: Glycopyrrolate (Drug)

结局指标

主要结局

Opioid (morphine equivalent) requirement in the first 24 h postoperatively

时间窗: up to 24 hours postoperatively

total morphine consumed in the first 24 h postoperatively

次要结局

  • Visual analogue scale (VAS) scores for pain severity(up to 24 hours postoperatively)
  • Time to first voiding(up to first 24 hours postoperatively)
  • Patient satisfaction following Laparoscopic cholecystectomy(at 24 hours postoperatively)
  • Time to first perception of pain(up to 24 hours postoperatively)
  • Incidence of postoperative nausea and vomiting (PONV).(up to 24 hours postoperatively)
  • Sedation score using Ramsay Scale.(up to 24 hours postoperatively)

研究者

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

Joshan Lal Bajracharya

Junior resident

B.P. Koirala Institute of Health Sciences

研究点 (1)

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