跳至主要内容
临床试验/CTRI/2016/02/006692
CTRI/2016/02/006692尚未招募Unknown

Efficacy of preemptive multimodal analgesia for post operative pain relief in trauma patients undergoing lower limb surgery-A Randomised trial

Post Graduate Institute Of Medical Education Research1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2016年1月3日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
入组人数
250
试验地点
1
主要终点
Mean number of boluses of PCA or PCEA

研究概览

简要总结

Group PE will receive the following preemptive multimodalpharmacologic agents-,Intravenous diclofenac 75 mg, intravenous morphine3mg, 1gm of intravenous acetaminophen and 75mg pregabalin per orally.

After assessing for eligibility,patients will be explained about the study protocol, the use of the PCA pump, numericalrating score (NRS) and written informed consent will be obtained. All patients will beexplained to report pain intensity on a VAS score of 0-10 where 0= no pain and10= worst possible pain. For descriptive purposes, pain score between 0-3 willbe taken as mild pain, 4-7 as moderate pain, 7-9 as severe pain and 10 asintolerable pain.

One hour prior to surgery, the sealedenvelope will be opened and the card inside will determine the group allocation.The drugs willbe administered at least 1 hour before surgery by a blinded anesthesiologistwho will not participate in post operative assessment.

After securing intravenous cannula andadequate hydration with Ringer lactate , spinal anesthesia would be initiatedwith 3ml of 0.5% hyperbaric bupivacaine. In case general anesthesia is required, standard institute protocol shall be followed. All patients will be managedintraoperatively with combined spinal epidural anesthesia or general anesthesia with the sameperioperative departmental protocol. Type of surgery, duration of surgery,baseline haemoglobin, blood loss, no of hypotensive episodes, intraoperativeblood transfusion, intraoperative use of opoids and NSAIDS will be noted. Theattending anesthesiologist will not be involved in the patients’ evaluationpost-operatively.

All patients will be connected to a patient-controlled epidural analgesiapump (PCEA Plus; Abbott, Chicago, IL, USA) or Patient controlled analgesia upon arrival in the post-anesthesiacare unit.. The patients will be instructed to pushthe button of the PCEA system or PCA each time they felt pain. The patient-controlledanalgesia will be set at a bolus of 5 ml of 0.2 % ropivacaine with 2μgm/ml offentanyl with a lockout time of 30 min in or 2ml of 1mg/kg morphine  At any point of time, if patientcomplains of pain with NRS>3, morphine 3mg will be given as rescue analgesiaand time recorded..Postoperative NRS scores will be recorded when the patient is admitted to thetrauma recovery room, after 30 min, 1 hr, 2 hrs, 4hrs, 8hrs, 12 and 24 hrs andon postoperative day 2. Postoperative nausea, vomiting, sedation scores will beassessed at arrival time, 6 hrs and 24 hrs. Any episodes of respiratorydepression, apnea, hypoventilation, desaturation will be noted.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing post traumatic long bone surgeries of femur and tibia.

排除标准

  • History of associated head injury, blunt trauma abdomen or blunt trauma chest 2) allergy and contraindications to any of the medications being used 3) history of being on chronic pain medications (i.e. slow-release preparations of opioids) 4) rheumatoid arthritis 4)psychiatric disorder 5) a history of diabetes with impaired renal function 6) morbid obese 7) patients unable or unwilling to use patient-controlled epidural analgesia (PCEA).
  • (8) prior use of the investigated medications (9) current use of anticoagulants or antiplatelet medication.

结局指标

主要结局

Mean number of boluses of PCA or PCEA

时间窗: At 24 and 48 hrs

次要结局

  • Mean VAS scores in post operative period(Postoperative nausea, vomiting, sedation scores)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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