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临床试验/NCT02625506
NCT02625506已完成不适用

Efficacy of Adding Tramadol as Adjunctive Analgesic With Levobupivacaine in Modified Pectoral Nerve Block for Modified Radical Mastectomy Surgery

Mansoura University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Postoperative pain

研究概览

简要总结

The aim of this study is to evaluate the addition of tramadol combined with levobupivacaine in the reduction of postoperative pain, postoperative opioid consumption after modified radical mastectomy surgery.

详细描述

Breast surgeries are usually associated with sever postoperative pain ,good perioperative analgesic technique after breast surgery is always questionable Thoracic epidural and paravertebral blocks became the gold standard techniques for pain relief, however they may be associated with complications such as spinal cord injury, total spinal anesthesia ,inadvertent intravascular injection and pneumothorax.

Pecs block is less invasive procedure involving ultrasound guided inter-fascial injections which has been suggested as potential alternative analgesic technique.

The block produces excellent analgesia and can be used as a rescue block in cases where the analgesia provided by the paravertebral or epidural was patchy or ineffective .

Different drugs, including opioids, non-steroidal anti-inflammatory drugs, ketamine, clonidine, and neostigmine, have been added to local anesthetics to improve the duration and quality of analgesia.Tramadol has also been used for pain management of patients.

The power of this clinical trial was prospectively calculated using the G Power analysis program. Using a priory power analysis with accuracy mode calculations with visual analogue score (VAS) as the primary variant and assuming type I error protection of 0.05 and an effect size convention of 0.9, a total sample size of 54 patients (27 patients in each group) produced a power of 0.90. To protect against drop out cases we added 6 cases to the total number (total of 60 cases)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • American Society of Anesthesiologists physical status I or II.
  • Patients scheduled for radical mastectomy surgery.

排除标准

  • Severe or uncompensated cardiovascular diseases
  • renal diseases
  • Hepatic diseases
  • Endocrinal diseases.
  • Pregnancy
  • Postpartum
  • Lactating females
  • Allergy to study medications.
  • Local skin infection
  • Bleeding disorder
  • Coagulation abnormality
  • Spine deformity
  • chest deformity
  • Psychiatric disease

研究组 & 干预措施

Levobupivacaine

Placebo Comparator

Patients will be subjected for radical mastectomy surgery and pectoral nerve block with levobupivacaine

干预措施: Levobupivacaine (Drug)

Levobupivacaine and Tramadol

Active Comparator

Patients will be subjected for radical mastectomy surgery and pectoral nerve block with levobupivacaine and tramadol

干预措施: Levobupivacaine and Tramadol (Drug)

结局指标

主要结局

Postoperative pain

时间窗: For the first 24 hours after surgery

Postoperative pain will be assessed by utilizing visual analogue scale (VAS)

次要结局

  • Total analgesics received for 24 hrs after surgery(for 24 hours after surgery)
  • Time for first analgesic request from extubation(for 24 hours after surgery)
  • Changes in heart rate(For one hour after surgery)
  • Changes in blood pressure(For one hour after surgery)
  • Changes in peripheral oxygen saturation(For one hour after surgery)
  • Changes in end-tidal carbon dioxide tension(For one hour after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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