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临床试验/NCT03265223
NCT03265223已完成4 期

Randomized Controlled Study of Intraincisional Infiltration Versus Intraperitoneal Instillation of Standardized Dose of Ropivacaine 0.2% in Post-laparoscopic Cholecystectomy Pain

Jawaharlal Nehru Medical College0 个研究点目标入组 353 人开始时间: 2014年4月1日最近更新:
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
353
主要终点
Effect of ropivacaine use intraincisionally versus intraperitoneally as compared to controls on post-laparoscopic cholecystectomy pain

研究概览

简要总结

Pain still remains a limiting factor in early discharge of patients undergoing laparoscopic cholecystectomy. Almost all earlier studies done to compare the efficacy of local anaesthetics used intraperitoneally as compared to intraincisionally used equal amounts of drugs at the two locations, usually 10-20 ml. Using this large amount of drug in the small space of intraincisional location as compared to similar amount of drug in large intraperitoneal space created an inadvertent bias in favor of patients receiving the drug intraincisionally so such patients naturally experienced less pain. The investigators decided to standardize the drug used at these two locations as 1ml/cm and conduct a new study comparing the effects of drugs in relieving pain when used at these two locations.

详细描述

Aims & Objectives: To conduct a randomized, triple-blind, placebo-controlled study by standardizing dose of local anesthetic, to compare the effectiveness of intraperitoneal against intraincisional use of ropivacaine 0.2% for post-laparoscopic cholecystectomy pain relief.

Materials & Methods: American Society of Anesthesiologists (ASA) physical status I or II patients underwent elective 4 port laparoscopic cholecystectomy by a single surgeon. Anesthetic and surgical techniques were standardized. Patients were randomized using envelope method into 3 groups according to location of drug use. Triple blinding was ensured and envelopes were opened only at the completion of study. All patients received ~23 ml of solution, of which 20 ml was given intraperitoneally [1 ml/cm; 16 ml along right hemi-dome, approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in gall bladder fossa) and ~3 ml intraincisionally (1 ml/cm of length of incision). Controls (n=86) received ~23 ml normal saline (20 ml intraperitoneally and 1 ml/cm intraincisionally) while the intraperitoneal group (n=100) received 20 ml of intraperitoneal instillation of injection ropivacaine 0.2% and 1 ml/cm of normal saline intraincisionally at the end of procedure. Intraincisional group (n=108) received 20 ml normal saline intraperitoneally and 1 ml/cm of injection ropivacaine 0.2% infiltration at incisional site at the end of procedure. All patients received injection diclofenac sodium 75mg/1ml (aqueous) intravenously 12 hourly postoperatively. 5 different pain scales were used for assessment of overall pain. Pain scores were assessed at 5 points of time, that is, at 0.5, 4, 8, 12 and 24 hours postoperatively. Shoulder pain and extra dose of analgesic required (rescue analgesia) were also recorded.

研究设计

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

盲法说明

Triple blinding was done i.e. neither the operating surgeon nor the investigator and nor the patient knew to which study group patient belong to.

入排标准

年龄范围
15 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients in the age group of 15-80 years
  • Patients conferring to Grade I or II of American Society of Anesthesiologists (ASA) physical status classification system only
  • Patients undergoing elective Laparoscopic Cholecystectomy
  • Patients having symptomatic cholelithiasis only
  • Patients operated by a single surgeon were included.

排除标准

  • Patients with known allergic reactions to local anesthetics
  • Cases that were converted to open cholecystectomy
  • Patients with major intra-operative complications
  • Patients suffering from acute cholecystitis, empyema or malignancy of gall bladder, having history of chronic pain or those taking frequent analgesics or opioids pre-operatively
  • Patients with peptic ulceration, bleeding disorders, impaired renal and/or hepatic function, and sensitivity to NSAIDs or opioids.
  • Patients in whom gall bladder (GB) stones are found incidentally on ultrasonography (USG) (asymptomatic cholelithiasis)
  • Patients suffering from severe chronic medical diseases and morbid obesity
  • Patients unable to comprehend instructions or having communication problems were excluded from the study.

研究组 & 干预措施

Intraperitoneal group

Active Comparator

Received 20 ml of 0.2% ropivacaine intraperitoneally (1 ml/cm; 16 ml along right hemi-dome, approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in gall bladder fossa) and 3 ml normal saline (1ml/cm of port site incision length)

干预措施: 0.2% ropivacaine (Drug)

Intraincisional group

Active Comparator

Received 20 ml of normal saline intraperitoneally (1 ml/cm; 16 ml along right hemi-dome, approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in gall bladder fossa) and 3 ml 0.2% ropivacaine (1ml/cm of port site incision length)

干预措施: 0.2% ropivacaine (Drug)

结局指标

主要结局

Effect of ropivacaine use intraincisionally versus intraperitoneally as compared to controls on post-laparoscopic cholecystectomy pain

时间窗: 36 months

To study and assess the effect and impact of using the local anesthetic ropivacaine 0.2%, over controls, on the intensity of postoperative pain in patients undergoing laparoscopic cholecystectomy; and to compare and assess the optimal site i.e. intraincisional versus intraperitoneal of using local anesthetic (ropivacaine) for better post-laparoscopic cholecystectomy pain relief.

次要结局

  • Identify the component of pain which is dominant after undergoing laparoscopic cholecystectomy(36 months)
  • Laparoscopic cholecystectomy as day-case using ropivacaine only(36 months)
  • Changing trends in epidemiology of cholelithiasis(36 months)

研究者

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

Kaushal Deep Singh

Principal Investigator

Jawaharlal Nehru Medical College

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