Erector Spinae Plane Block Impact on Quality of Recovery After Lumbar Spinal Decompression Surgery; a Comparative Study Between Addicts and Non-addicts
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The quality of recovery score (QoR-15) at 24th hour
研究概览
简要总结
Erector spinae plane block (ESPB) as a new trunk fascia block technique was proposed in 2016. ESPB has aroused the interest of many nerve block experts. The benefits of ESPB are not yet demonstrated. The specific mechanism is still controversial. Some believe that ESPB can block the posterior root of the spinal nerve and produce part of the para-spinal block effect with the diffusion of the drug solution.
The present study will carried out to compare the performance of the erector spinae plane block combined with general anesthesia in addicts versus non addicts' patients regarding the local analgesic effect, recovery after surgery and side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double blinded
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male gender.
- •Age range of 18-60 years.
- •Scheduled for open lumbar decompression surgery.
- •A minimum of 1-year experience of drug consumption or having drug withdrawal symptoms when stopping for inclusion in the drug addicts group(according to the patient's statement and rapid opiate urine test).
排除标准
- •Hepatic or renal insufficiency.
- •Preoperative cognitive dysfunction or communication disorder.
- •Allergy to amide-type local anaesthetics.
- •Back puncture site infection.
- •Coagulation disorders.
- •Emergency surgery.
研究组 & 干预措施
Group (A)
History of addiction.
干预措施: Bupivacain (Drug)
Group (N)
No history of addiction to any drug.
干预措施: Bupivacain (Drug)
结局指标
主要结局
The quality of recovery score (QoR-15) at 24th hour
时间窗: at 24th hour
This questionnaire covers a total of 15 questions under five clinical dimensions of health; physical comfort (five-item), emotional status (four-item), psychological support (two-item), physical independence (two-item) and pain (two-item). a numerical rating scale of 11 point for each question leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).
次要结局
- Postoperative pain.(At half an hour, 2, 4, 8, 12, 24 hours.)
- Intraoperative fentanyl dosage.(From the start of operation till its end up to 3 hours.)
- First-time morphine use.(In 24 hours)
- First time to ambulation after surgery.(In 24 hours)
- Length of hospital stay.(up to 3 days.)
研究者
Fatma Ahmed Abdel Fatah
Lecturer
Benha University