Comparison of Thoracolumbar Interfascial Plane Block (TLIP-block) and Local Anesthetic Infiltration in Minimally Invasive Spine Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Total morphine consumption
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of the thoracolumbar interfascial plane block (TLIP block) versus local anesthetic (LA) infiltration in managing postoperative pain in minimally invasive surgery (MIS) for spine surgery.
The primary outcome was total morphine consumption. Secondary outcomes included pain scores using the the numerical verbal scale (NRS), opioid-related side effects, time of the first request for rescue analgesia, time to ambulation and hospital length of stay.
详细描述
A single-center, prospective, double-blind, randomized controlled trial at Queen Savang Vadhana Memorial Hospital.
All 40 enrolled patients were randomized to receive the assigned intervention, Thoracolumbar interfascial plane group (TLIP group) and local anesthetic (LA) infiltration group (LA group).
- For TLIP group, patients will receive ultrasound-guild bilateral TLIP block with a total of 40 ml of 0.25% Bupivacaine.
- For LA group, patients will receive local anesthetic infiltration with a same drug by orthopedic surgeon.
At the end of surgery, patients were extubated and transferred to the PACU before being shifted to the orthopedic ward.
Postoperative assessments began upon admission to the PACU, designated as time zero, and continued at regular intervals in the orthopedic ward (6-, 8-, 12- and 24-hours post-surgery).
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
- Triple (Participant, Care Provider, 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
- •Older than 18 years
- •American Society of Anesthesiologists classes I-III
- •Able to use a patient-controlled analgesia (PCA) device
- •Able to rate their pain using a numerical verbal scale (NRS)
排除标准
- •Declined to participate
- •Uncooperative or unable to complete study assessments
- •Had contraindications to the medications used in the study protocol and regional anesthesia.
- •History of alcohol or substance abuse within two years prior to surgery,
- •Allergies to medication used in the study protocol
- •Pregnancy.
结局指标
主要结局
Total morphine consumption
时间窗: 24 hours
Total doses of morphine requirement during first 24 hours postoperative period (The investigators recorded at 6,8,12 and 24 hours, postoperatively)
次要结局
- Length of hospital stay(2 weeks)
- Pain score (NRS)(24 hours)
- Postoperative nausea and vomiting(24 hours)
- Time of the first request for rescue analgesia(24 hours)
- Respiratory depression(24 hours)
研究者
Sophitnapa Tanasittiboon
Principal Investigator
Queen Savang Vadhana Memorial Hospital, Thailand