跳至主要内容
临床试验/NCT02568995
NCT02568995已完成3 期

Postoperative Pain Management Following Total Hip Arthroplasty. A Comparison Between Local Infiltration Analgesia and Ultrasound Guided 3-in-1 Block

Örebro University, Sweden3 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
55
试验地点
3
主要终点
Pain intensity

研究概览

简要总结

Total hip arthroplasty (THA) is a common and standardized procedure. Postoperative mortality after hip joint replacement is low but some complications remain, including chronic post-surgical pain (1), hip dislocation (2), infection (3), and deep vein thrombosis (4). Strategies that have been identified to reduce morbidity and mortality include: posterior surgical approach, mechanical and pharmacological prophylaxis of deep vein thrombosis, and the use of spinal anesthesia (5). One of the important factors for patient satisfaction with lower limb arthroplasty is good postoperative pain management (6). Poorly managed postoperative pain can lead to chronic post-surgical pain and therefore aggressive postoperative pain management is important (7). Several different methods have been used to treat postoperative pain following THA. Recently, local infiltration analgesia (LIA) using a combination of large volume local anesthetics (LA) and non-steroidal anti-inflammatory agents (NSAID) injected systematically peri-articularly has been used for pain management with variable success (8). We found that better analgesia could be achieved when using LIA compared to intrathecal morphine during the first few days postoperatively (9,10).

Ultrasound techniques are commonly used for peripheral nerve blocks and have been shown to reduce pain intensity and may be considered by many to be a standard of care. Specifically, the 3-in-1 block has been commonly used because of its ease of application and good pain management following total hip arthroplasty. The present study aims to compare postoperative pain intensity following local infiltration analgesia with a standardised 3-in-1 block for total hip arthroplasty.

详细描述

Sixty ASA I-II patients undergoing THA would be randomised to one of two groups in a double-blind study:

Group LIA: A total of 151.5 ml of a combination of 0.2% ropivacaine (150 ml), 30 mg ketorolac (1 ml) and 0.5 mg (0.5 ml) adrenaline was administered systematically peri-articularly during THA and 30 ml of normal saline for ultrasound-guided 3-in-1 block Group Femoral block: Received 30 ml of ropivacaine 0,75% for ultrasound-guided 3-in-1 block and a total of 151.5 ml of normal saline peri-articularly.

All patients would receive spinal anaesthesia with 0.5% heavy bupivacaine for surgery

Postoperatively, the following parameters would be measured:

  1. Pain intensity at fixed time intervals during 0-7 days and thereafter at weekly intervals for 1 month
  2. Rescue morphine consumption during 0-4, 4-24 and 24-48 h
  3. Side effects and complications
  4. Home readiness and length of hospital stay
  5. Chronic pain intensity measured after 3 and 6 months using the Brief Pain Inventory
  6. Plasma Cytokine concentration at fixed intervals
  7. Motor block using Bromage scale
  8. EQ5D and HOOS questionnaires

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
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 40-80 years
  • THA operation

排除标准

  • Chronic pain requiring opiates
  • Language constraints preventing completion of the study
  • Contraindications to regional block

研究组 & 干预措施

LIA

Experimental

Local infiltration analgesia using a combination of ropivacaine 300 mg + ketorolac 30 mg + adrenaline 0.5 mg

干预措施: ropivacaine + ketorolac + adrenaline (Drug)

Femoral nerve block

Active Comparator

Ultrasound guided 3-in-1 block using 30 ml of 0.75% ropivacaine

干预措施: ropivacaine + ketorolac + adrenaline (Drug)

结局指标

主要结局

Pain intensity

时间窗: 24 h

Pain intensity during movement at 24 h after end of surgery

次要结局

  • Rescue analgesic consumption(0-24 h)
  • Chronic pain(3-6 months)
  • Inflammation(Preoperative to 3-5 days postoperatively)

研究者

发起方
Örebro University, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anil Gupta

Associate Professor

Örebro University, Sweden

研究点 (3)

Loading locations...

相似试验