2023-509109-57-01招募中4 期
Hip Infiltration in Hip Arthroplasty (HiHa) study – a randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Use of escape pain medication during the first 6 hours after the intra-articular injection of the hip
研究概览
简要总结
The main objective is to determine if preoperative intra-articular infiltration (IAI) of the hip joint with Ropivacaine and Adrenaline reduces the number of patients needing postoperative escape pain medication after total hip arthroplasty, compared to a placebo AIA of the hip joint.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •On the waiting list for primary THA via the ASI by one of participating orthopaedic surgeons
- •ASA 1, ASA 2 or ASA 3
- •Eligible to receive the full enhanced recovery pain- and anesthetic protocol
- •Willing to participate
- •Willing to provide written informed consent
排除标准
- •Decline to participate
- •Participants will be excluded postoperatively if the duration of surgery exceeds 90 minutes
- •Unable to effectively communicate in Dutch or English
- •Use of opioids preoperatively
- •Use of NSAID’s for an indication other than the hip for which surgery is planned
- •Allergy or contraindication for the contents (Ropivacaine or adrenaline) of the preoperative infiltration
- •Allergy or contraindication for medication used in the standardized postoperative pain protocol
- •Allergy or contraindication for medication used in the standardized anaesthetic protocol
- •Allergy or contraindication for the standardized escape medication
结局指标
主要结局
Use of escape pain medication during the first 6 hours after the intra-articular injection of the hip
Use of escape pain medication during the first 6 hours after the intra-articular injection of the hip
次要结局
- Percentage of patients that use escape pain medication on day 0 and during hospital stay until discharge
- Pain measured with NRS
- Side effects related to the use of pain medication
- Amount of other escape medication used
- Satisfaction measured with the Net Promotor Score (NPS)
- Perioperative blood loss
- Need for blood tranfusion
研究者
N.M.C. Mathijssen
Scientific
Reinier Haga Groep Orthopedisch Centrum B.V.
研究点 (1)
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