Effect of Neuromuscular Blockade on Surgical Conditions and Patient Reported Comfort Scores in Total Hip Replacement Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Surgical conditions during luxation on a four-grade numeric scale
研究概览
简要总结
During Total hip replacement arthroplasty (THA), the hip joint first must be luxated in order to have access to the joints. A lot of force and torque must be carried out on the joint to perform this manipulation. This is both difficult for the surgeon and may cause additional tissue damage and postoperative pain. After placement of the prosthesis and reduction of the joint, the tension of the hip joint must be evaluated by the surgeon to ascertain the adequacy of the prosthesis. During luxation, minimal muscle tension would be ideal, while after reduction of the joint, normal muscle tension is desired to permit assessment of the mechanics of the hip joint.
The aim of the study is to investigate whether deep neuromuscular block, combined with a reversal before mechanics assessment improves surgical conditions, surgical time, and postoperative patient comfort.
详细描述
2X20 patients are randomised: Rocuronium-group (R-group) and Placebo-group (P-group).
All patients receive standardised multimodal intravenous analgesia. After standardised induction of anasthesia and patient positioning, the patient is administered either placebo or rocuronium 0.9 mg/kg, followed by continuous infusion of either placebo or rocuronium 0.4 mg/kg/h. 1 minute before reduction of the hip joint, the patient is administered either sugammadex (R-group) or placebo (P-group) for full reversal of the neuromuscular block.
During the surgery, time points are recorded for: incision, start luxation of the joint, start reduction of the joint, start skin closure.
The surgeon is blinded for patient allocation. At three moments (after luxation, just before reduction of the joint, and after assessment of joint mechanics), the surgeon is asked to appraise the surgical conditions on an analogue scale.
Postoperative analgesic consumption and pain scores are recorded. VAS scores for knee pain and hip pain are assessed before surgery, at the moment of discharge from the post-anesthesia care unit (=D0), the morning after surgery (=D1), at D2, and at D7.
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)
盲法说明
The syringes are prepared by the research assistant who was not involved in patient management. The anesthetist and surgeon are blinded for patient allocation.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent
- •eligible for primary THA
排除标准
- •neurological or psychiatric disorders
- •intolerance or allergy against investigational drugs or any of the drugs used in the standardized analgetics scheme (acetaminophen, diclofenac, ketamine, clonidine, lidocaine)
研究组 & 干预措施
Placebo
Placebo alternative for rocuronium and for sugammadex
干预措施: Placebo (Drug)
Rocuronium
Rocuronium as bolus and in syringe pump Sugammadex just before reduction of the joint
干预措施: Rocuronium (Drug)
Rocuronium
Rocuronium as bolus and in syringe pump Sugammadex just before reduction of the joint
干预措施: Sugammadex (Drug)
结局指标
主要结局
Surgical conditions during luxation on a four-grade numeric scale
时间窗: during surgery, during luxation of the joint
Excellent - good but not optimal - poor but acceptable - unacceptable
次要结局
- Patient reported pain scores on a VAS score (0-100 ; 0=no pain , 100=worst pain)(day 0-1-2-7 (day 0 = day of surgery))
- Surgical conditions for assessment of joint kinetics on a four-grade numeric scale(during surgery, after reduction of the joint)
- surgery time(during surgery)
- Surgical conditions during reduction of the joint on a four-grade numeric scale(during surgery, during reduction of the joint)
研究者
Dr. Alain Kalmar, MD, PhD
Staff Anesthetist
Algemeen Ziekenhuis Maria Middelares