Postoperative Pain Relief Following Total Hip Arthroplasty. A Comparison Between Intrathecal Morphine (IM) and Local Infiltration Analgesia (LIA)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Total morphine consumption postoperatively
研究概览
简要总结
Postoperative pain following total hip arthroplasty (THA) (1) is often considered moderate to severe and can therefore influence the postoperative course of event and result in delayed postoperative mobilization and prolonged hospitalization. It is therefore necessary to find the most optimal method for alleviation of pain for these patients. Traditionally, this has been managed by epidural analgesia, continuous peripheral nerve blocks, parental- or spinal opioids. Recently, Drs Kerr and Kohan at the Joint Orthopaedic Centre in Sydney, Australia developed a local infiltration analgesia (LIA) technique. The technique was introduced in Scandinavia during 2001 and has been shown to be efficacious during knee surgery. The LIA technique is based on a systemic infiltration of a mixture of a long-acting local anaesthetic (ropivacaine), a non steroidal anti-inflammatory drug (ketorolac), and epinephrine into the tissue around the surgical field to achieve satisfactory pain control with little physiological disturbance. A catheter is left from the skin and into the joint cavity, allowing repeated injection on the morning after surgery (10). Effective pain relief with early mobilization and reduced hospital stay has been reported following total knee arthroplasty and, recently, following unicompartmental knee arthroplasty.
The aim of this study is to assess whether LIA technique is equi-efficacious to intrathecal morphine, the standard of care in our hospital.
详细描述
This is a randomized, double blind parallel-group study where two different methods for postoperative pain relief after total hip arthroplasty, intrathecal morphine (IM) and local infiltration analgesia (LIA), will be assessed.
The study will be conducted at the Department of Anaesthesiology and Intensive Care and the Department of Orthopaedic Surgery, at USÖ. A total of 80 patients undergoing total hip arthroplasty will be included in the study, 40 patients in group IM and 40 patients in group LIA. The patients will be divided into one of the two groups according to computer-generated randomization. Study duration per patient will be 6 months.
Screening on the basis of inclusion and exclusion criteria will take place at the preoperative assessment at the outpatients' anesthesia clinic 3 - 6 weeks before the total hip arthroplasty. One of the participating investigators will inform the patient, both verbally and in writing, about what participation in the study involves. The patient will be given time to ask questions and to consider participation in the study.
If the patient wants to be enrolled in the study, inclusion will take place at the preoperative assessment that takes place before the total hip arthroplasty. One of the participating Investigators would inform the patient again about what participation in the study means. The patient will be given time to ask questions and to consider participation in the study. The patient can be enrolled in the study after signing and dating the written Informed Preoperative Preparation The patients will be informed in details about the surgery, anesthesia, postoperative pain relief and physiotherapy. All patients will be asked to complete two health related quality of life questionnaires, SF-36 and EQ5D (appendix 2 and 3).
A baseline value for HOOS (appendix 4) and NRS (Numeric Rating Score) will be assessed prior to surgery. The patients will also be instructed on how to use the patient controlled analgesia (PCA) morphine pump that will serve as post-operative rescue medication in case of pain > 3 on the numeric rating scale (NRS) Dalteparin 5000 IU is administered subcutaneously once each evening for 10 days, starting the night before surgery for thrombo-prophylaxis.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 - 80 year-old undergoing total hip arthroplasty.
- •ASA I - II (appendix 1).
- •Have signed and dated Informed Consent.
- •Willing and able to comply with the protocol for the duration of the trial.
排除标准
- •Re-operation of a previous total hip arthroplasty.
- •Allergy/intolerance to local anaesthetics, Morphine, Adrenaline, Ketorolac or Ropivacaine.
- •Serious liver- or renal disease judged by the investigator to be of such dignity as to prevent inclusion into the study.
- •Serious heart disease judged by the investigator to be of such dignity as to prevent inclusion into the study,
- •Patients with chronic pain who are taking opiate analgesics regularly.
- •Major bleeding disorders
- •Chronic obstructive pulmonary disease (COPD)
- •Severe asthma that is difficult to treat
- •Limited breathing capacity due to muscular dystrophy
- •Sleep apnoea syndrome
- •Other contraindication to spinal anaesthesia such as spinal stenosis, local infection or contraindications to local anaesthetics.
- •Participation in another clinical medicinal trial during the last 30 days or where follow-up is not completed.
研究组 & 干预措施
Local Infiltration Analgesia
Combination of ropivacaine, ketorolac and adrenaline
干预措施: LIA (Drug)
Intrathecal morphine
Morphine special (preservative-free) injected intrathecally
干预措施: I/T morphine (Drug)
结局指标
主要结局
Total morphine consumption postoperatively
时间窗: During 0 -24 hours postoperatively
Other than total morphine consumption, even pain intensity on movement would be considered to be an important parallel end-point.
次要结局
- Pain intensity (NRS, Numeric Rating Score; 0-10)(0 - 24 h)
研究者
Per Essving
Assistant Professor
Region Örebro County