Adjuvant Analgesic Effects of Low Dose Tramadol/Acetaminophen Combination After Open Gynaecological Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
Patient experience moderate to severe pain after abdominal surgery. This post-operative pain can also contribute to complications such as respiratory impairment, cardiovascular events, ileus, sleep deprivation and mood disturbance. Opioid based patient-controlled analgesia (PCA) is commonly employed but opioids have the side effects such as respiratory depression, nausea and vomiting, sedation, pruritus and urinary retention. Bowel motility can also be affected. Consequently alternative or adjunct analgesic medications without these side-effects have been investigated in order to reduce opioid consumption.
Multimodal analgesia is a technique whereby a combination of analgesic drugs with different modes of action can be used to improve analgesia and decrease adverse effects by virtue of synergism. Postoperatively, with adjunctive analgesia, PCA morphine consumption as well as the side effects may be reduced. Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to be opioid sparing and decrease the adverse effects of PCA morphine. A recent review showed that acetaminophen combined with PCA could induce a significant opioid-sparing effect but the incidence of PCA morphine related side effects were not reduced.
It is common nowadays to give oral analgesic supplements to post-operative patients on PCA morphine. Tramadol, an analogue of codeine, is one of the choices. However, some of the patients cannot tolerate the side effects such as nausea, drowsiness, sweating, postural hypotension and dry mouth. Combination of tramadol 37.5 mg and acetaminophen 375 mg, which has been used successfully to treat post-operative pain, may improve analgesic response with better tolerability.
This study is to assess tramadol 37.5 mg and acetaminophen 375 mg combination on the efficacy of pain control, down stepping of morphine consumption and related adverse events with PCA use after open colorectal surgeries.
Objectives:
This study aims to compare and evaluate:
- The efficacy of tramadol/acetaminophen combination on postoperative pain relief after lower abdominal surgeries
- The effects of tramadol/acetaminophen combination on the consumption and the duration of PCA morphine use
- The adverse effects related to this regimen
- The effects on postoperative bowel function, tolerability of fluid and diet, ambulatory function, sleep, and duration of hospital stay
- The overall satisfaction of the patients
详细描述
This is a randomized, double-blinded, placebo-controlled study.
Study site Patients will be recruited and studied at Queen Mary Hospital, Hong Kong.
Anaesthesia for operation No premedication will be prescribed. Patients will be induced with fentanyl 1 to1.5µg/kg, thiopentone 2-4mg/kg or propofol 2-3mg/kg and rocuronium 1mg/kg. Anaesthesia will be maintained with cisatracurium and isoflurane with air and oxygen. Intravenous morphine will be used for pain relief intraoperatively.
Postoperative PCA settings
After the operation, at the recovery area, patients will be given boluses of intravenous morphine until satisfactory pain control, i.e. numerical rating scale (NRS) less than 4. PCA machine will then be connected and patient will learn the technique of using PCA. The PCA pump will be programmed as follow:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA I to III
- •Age 18 to 80 years
- •Scheduled for elective lower abdominal surgery (gynecological or colorectal surgery) at Queen Mary Hospital, Hong Kong
排除标准
- •Allergy to tramadol, acetaminophen, or other opioid drugs
- •Patient with epilepsy or history of seizures
- •Concurrent use of selective serotonin uptake inhibitors, tricyclic antidepressants, or monoamine oxidase inhibitors
- •Impaired or retarded mental state
- •Impaired renal function, defined as preoperative serum creatinine level over 120µmol/L
- •Impaired hepatic function, defined as preoperative serum albumin level less than 30g/L
- •Intraoperative use of clonidine or dexmedetomidine
- •Patient requiring postoperative mechanical ventilation
- •Difficulties in using patient-controlled analgesia
- •Pregnancy
- •Current or previous drug abuser
- •Alcoholism
- •Patient refusal
研究组 & 干预措施
acetaminophen
Acetaminophen was used as active control.
干预措施: acetaminophen (Drug)
Tramadol/acetaminophen
The tramadol and acetaminophen combination was given to patients at the same day after surgery.
干预措施: tramadol/acetaminophen (Drug)
结局指标
主要结局
Pain score
时间窗: Postoperative 48 hours
次要结局
- postoperative morphine consumption, side effect, recovery, sleeping quality, satisfaction(Postoperative 48 hours)
研究者
Cheung Chi Wai
Dr.
The University of Hong Kong