Continuous Local Anesthetic Wound Infusion to Improve Quality of Recovery Following Ablative Surgery and Neck Dissection: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Quality of Recovery
研究概览
简要总结
The goal of this study is to assess the efficacy of continuous local anesthetic wound infusion to improve quality of recovery following ablative surgery and neck dissection.
详细描述
Bilateral cervical plexus catheters are convenient and safe to place under the direct vision of the surgeons during ablative and neck dissection. The investigators hypothesize that continuous local anesthetic wound infusion to block bilateral cervical plexus will improve quality of recovery following ablative surgery and neck dissection. The primary endpoint is the quality of recovery, which will be assessed using the 15-item quality of recovery questionnaire (QoR-15). Secondary endpoints include numeric pain scale, number and proportion of patients on salvage analgesics, Incidence of phrenic nerve block, Incidence of recurrent laryngeal nerve block, length of post-anesthesia care unit (PACU) stay, length of post-operative hospital stay.
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
Participants, clinicians, data collectors, outcome adjudicators and data analysts will not have access to details of group assignment.
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over age 18;
- •patients with head and neck cancer Undergoing ablative surgery and neck dissection.
排除标准
- •Patient refuse;
- •Relatively contraindications: severe heart, liver, or kidney dysfunction, coagulation dysfunction, and local anesthetic allergy history;
- •Intervention unlikely to be effective: drug abuse history, receiving other types of nerve block treatment;
- •Unlikely to complete the follow-up: alcoholism, planned to replace WeChat and phone within three months; the expected life span less than three months;
- •Unable to cooperate with the questionnaire and use the patient-controlled analgesia pump.
研究组 & 干预措施
CWI Block
Prior to the end of neck dissection and any additional procedures, the bilateral catheter will be placed adjacent to the cervical plexus underneath the internal jugular vein, left in place for 24 hours and removed in a similar way to the Redon drainage by the surgeon.
The Continuous placebo Wound Infusion (CWI) will start immediately at a speed of 4ml/h containing 0.5% lidocaine hydrochloride + 1:400000 adrenaline.
• Intervention: Drug: 0.5% lidocaine hydrochloride at 4ml/h.
干预措施: 0.5% Lidocaine Hydrochloride (Drug)
CWI Placebo
Control Intervention: Patients in the control arm will undergo the CWI procedure as well. The infusion will contain 0.9% normal saline + 1:400000 adrenaline at 4ml/h.
• Intervention: Drug: 0.9% normal saline at 4ml/h.
干预措施: 0.9% Normal Saline (Drug)
结局指标
主要结局
Quality of Recovery
时间窗: At 24 hours after surgery
The primary outcome will be the 15-item quality of recovery questionnaire (QoR-15).
次要结局
- Postoperative salvage analgesics(Up to 72 hours after surgery)
- Phrenic nerve block(Up to 72 hours after surgery)
- Numeric rating scale (NRS) for pain(Up to 72 hours after surgery)
- Recurrent laryngeal nerve block(Up to 72 hours after surgery)
- Quality of Recovery(Up to 72 hours after surgery)