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临床试验/CTRI/2018/04/013124
CTRI/2018/04/013124已完成不适用

Comparison of effects of intraoperative infusion of low dose ketamine versus lignocaine in post operative pain management in patients undergoing breast cancer surgery.

Govt medical collegeKozhikode1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
2. Total analgesic consumption in first 24 hours

研究概览

简要总结

Breastcancer surgery is a common surgery with many of the patients experiencingmoderate to severe pain, both acute and chronic postsurgical pain in the postoperative period. One of the modalities formanagement of postsurgical pain in breast cancer surgery is opioids but increasing no of recent reports regarding early reccurence of ma;ignancy with opioid usage is alarming. Opioidsare also associated with several adverse effects such as itching, postoperativenausea and vomiting, respiratory depression, etc. Concerns about opioid risk inthe postoperative period has aroused an increased interest in the use ofnon-opioid analgesic adjuvants. Intravenous lignocaine and low dose ketamineinfusions have individually shown to reduce the opioid consumption and toimprove the overall postoperative outcomes in several studies. There is apaucity of literature comparing the efficacy of these two drugs. So, we did thisstudy to compare the efficacy and duration of analgesia  and development of chronic pain with use of intravenouslignocaine and low dose ketamine in breast cancer surgery. This will help usfind out a superior technique with effective analgesia that will be veryhelpful to control pain and prevent its complication in many of the patientsundergoing breast surgery.

Study was conducted on 60 patients undergoingmastectomy after getting approval from Ethical committee and consent. Patients were randomised to two groups of 30 each. Preoperatively, all patients were instructed regardinghow to read the Numerical Rating Scale used for assessingthe pain in the postoperative period. Premedication was with oral ranitidine150 mg and metoclopramide 10 mg on the previous night of surgery and on themorning of surgery.

On arrival to the operation theatre, standard monitors were attached and baseline parameters wererecorded. Each patient received iv glycopyrrolate 10 mcg/kg, iv ondansetron 0.1mg/kg, iv midazolam 0.01mg/kg and iv fentanyl 2 mcg/kg. After pre-oxygenation for three minutes, patients wereinduced with Inj. Propofol 2mg/kg. Endotracheal intubation with appropriatesized, cuffed endotracheal tube was facilitated with Inj. Succinylcholine 1.5mg/kg. Anesthesia was maintained with nitrous oxide, oxygen and Isoflurane and Inj.Vecuronium bromide 0.1 mg/kg bolus for muscle relaxation. Additional doses ofvecuronium were given as deemed necessary by the attending anesthesiologist.

Group K received anintravenous bolus of ketamine 0.2 mg/kg before skin incision followed by 0.2mg/kg/hour until the end of the procedureand group L received an intravenous bolus dose of preservative free2% lignocaine 2 mg/kg before skin incision followed by 2 mg/kg/hour till theend of the procedure. Intra-operatively, patient’s vital signs were recordedperiodically and patients having fluctuations in HR and MAP >30% of baselinevalue were treated accordingly. After the completion of the procedure, all infusionswere stopped and the patient reversed with  Neostigmine  and  Glycopyrrolate and extubated. The time for extubation and the time forresponse to oral commands were recorded.

After the procedure, patients were monitored in therecovery room and in the post-operative ward. Any perioperative complicationssuch as tachycardia, bradycardia, hypertension, hypotension, nausea, vomiting,muscle twitching, seizures, respiratory depression were watched for.Numerical Rating Scale  for pain were assessed serially at 10minutes, 30 minutes, 1 hour, 4 hours, 12 hours and 24 hours after surgery. Inj.Paracetamol 1 gram iv and inj. Tramadol 50 mg iv were given as the first lineand second line rescue analgesics respectively and were administered if NRS ≥4. The time for first analgesic request was recorded. The duration of analgesiawas taken as the time at which patient complained of pain or the NRS was ≥ 4on assessment at serial intervals. The total dose of rescue analgesics neededin the first 24 hours were also recorded. Postoperatively, sedation was assessed soon afterextubation and after 30 minutes by using modifiedRamsay sedation score. Development of chronic postsurgical pain was assessed by telephonic enquiry of all patients after 3 months of surgery.

研究设计

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

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • •1.Female carcinoma breast sheduled for modified radical mastectomy
  • •Age 30-65 yrs
  • •American society of physical status I and II
  • •weight 40-70kg.

排除标准

  • •patients with chronic pain /on chronic analgesics or opioid
  • •Patient refusal
  • •Drug allergy 4.

结局指标

主要结局

2. Total analgesic consumption in first 24 hours

时间窗: 1. Duration of postoperative analgesia from end of surgical closure of wound | 2. Total analgesic consumption in first 24 hours

1. Duration of postoperative analgesia

时间窗: 1. Duration of postoperative analgesia from end of surgical closure of wound | 2. Total analgesic consumption in first 24 hours

次要结局

  • 1. sedation score after extubation(2. Chronic post surgical pain persisting after 3 months)

研究者

发起方
Govt medical collegeKozhikode
申办方类型
Government medical college

研究点 (1)

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