Obturator Nerve Block in Total Hip Arthrosplasty. a Randomized Controlled Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Oxycodone requirement in PACU
研究概览
简要总结
Interest of obturator nerve block for analgesia in total hip arthroplasty remains controversial. This regional anesthesia procedure could provide post-operative pain relief as obturator nerve is responsible for innervation of the internal part of the hip joint capsule.
This randomized double-blind study aims to assess obturator nerve block for post-operative analgesia in total hip arthroplasty.
Before the surgery, an ultrasound guided obturator nerve block will be performed with either 20cc of saline or ropivacaine 0.2% (a long-acting local anesthetics). After regional anesthesia, a general anesthesia will be performed for intraoperative period.
This study aims to assess post-operative pain management during the first 24 hours. Ability to walk the day of the surgery will also be collected.
详细描述
The best strategy to provide post-operative analgesia in total hip arthroplasty (THA) remains controversial. Many procedures have been descripted.
Recent anatomical studies have reported that obturator nerve provide innervation of the internal part of the hip joint capsule. Obturator nerve block could be of major interest as it might improve post-operative analgesia without providing motor block of the quadriceps muscle. This could be associated with an early ability to walk and enhanced recovery.
This randomized double-blind study aims to assess obturator nerve block after THA.
After information, written informed consent will be obtained from all subjects before inclusion. At patient arrival in the anesthetic room, the research assistant will check the patient's consent. Using a computer-generated random number table, patients will be randomized in two-treatment groups by resource not part of the study.
We have planned to include patients aged ≥18 years who were scheduled for primary THA under general anesthesia at the Elective Surgery Center, Clinique Medipole Garonne, Toulouse, France. The Elective Surgery Center annually performs approximately 1500 total hip arthroplasties.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •Primary THA under general anesthesia
- •Consent for participation
- •Affiliation to the french social security system
排除标准
- •Revision of hip arthroplasty
- •Significant psychiatric disturbances
- •Minor patient
- •Pregnancy
- •Breastfeeding
- •Patient is in exclusion period as determined by previous study
- •Contraindication to any drug used in the protocol: acetaminophen, ketoprofen, nefopam, oxycodone, propofol, ketamine, Ropivacaine...
- •Chronic pain
- •Current use oral morphine or equivalents
结局指标
主要结局
Oxycodone requirement in PACU
时间窗: Length of stay in PACU
In the PACU, patients will be assessed for pain using a verbal rating scale (VRS) (VRS, 0=no pain, 10=worst pain). Patients suffering from pain (VRS \> 4/10) will receive oxycodone 2 mg intravenous boluses / 3 minutes. Oxycodone requirement will be compared between interventional and control groups.
次要结局
- Postoperative Oxycodone consumption(Postoperative period : maximum 24 hours after surgery)
- Side effects of opioids(Postoperative period : maximum 24 hours after surgery)
- Pain assessement(Postoperative period : maximum 24 hours after surgery)
- Ability to walk(Postoperative period : maximum 24 hours after surgery)