Ultrasound-guided Sacral Erector Spinae Plane Block as a Sole Anesthetic Technique Versus Saddle Block in Hemorrhoidectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary outcome will be assessment of pain intensity using the NRS ranging from 0 (no pain) to 10 (worst pain) at 12 hours after the procedure.
研究概览
简要总结
Study interventions:
The patients will be randomized into two equal groups, Group A and Group B.
Group A: Patients will receive an Ultrasound guided sacral erector spinae plane block (SESPB)
Group B: Patients will receive Saddle block.
The surgical procedure will be performed by an experienced surgeon.
The outcome:
The primary outcome will be assessment of pain intensity using the NRS ranging from 0 (no pain) to 10 (worst pain) at 0, 2, 4, 6, 12, and 24 hours after the procedure. The secondary outcomes will include the cumulative doses of tramadol (50 mg intramuscular) to be repeated every 8 hours in case NRS score is more than four, the number of patients requiring rescue medication in the postoperative period.
详细描述
Study interventions:
The patients will be randomized into two equal groups using a computer-generated random numbers table, named Group A and Group B. An independent data manager, utilizing computer generated software, will be responsible for the randomization process. Patients will be assigned to the groups through sequentially numbered, sealed, opaque envelopes containing the computer-generated random numbers, which will be accessible only to the anesthesiologist performing the block. The subjects will be randomly allocated to one of the two groups.
Group A: Patients will receive an Ultrasound guided sacral erector spinae plane block (SESPB)
Group B: Patients will receive Saddle block.
Preoperatively, history taking, clinical examination and routine laboratory investigation will be performed, patients will be instructed to fast for 6 hours for solids and 2 hours for clear fluids. Upon arrival in the operation room, intravenous access will be established, and an acetated ringer's solution will be infused at a rate of 10ml/kg. ECG, noninvasive blood pressure and arterial oxygen saturation will be routinely monitored. The Numerical Rating Scale (NRS) will be used to assess pain intensity, and all study participants will be trained preoperatively to use the NRS pain score system.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with American Society of anesthesiologists' physical status (ASA) I to II.
- •Aged 18 to 65 years.
- •Both sexes.
- •Patients scheduled for perianal surgeries (hemorrhoidectomy).
排除标准
- •1- Patients with spinal malformation. 2-Patients with liver impairment. 3- Patients with renal impairment. 4-Patients younger than 18 years or older than 65 years. 5- Patients with hypersensitivity to one of the used drugs. 6- Coagulopathy disorders. 7- Patients who underwent hemorrhoidectomy before.
研究组 & 干预措施
SESPB
干预措施: Ultrasound guided sacral erector spinae plane block (SESPB) (Procedure)
Saddle
干预措施: Saddle block. (Procedure)
结局指标
主要结局
The primary outcome will be assessment of pain intensity using the NRS ranging from 0 (no pain) to 10 (worst pain) at 12 hours after the procedure.
时间窗: Twenty Four hours after the procedure
The primary outcome will be assessment of pain intensity using the NRS ranging from 0 (no pain) to 10 (worst pain) at 12 hours after the procedure.
次要结局
未报告次要终点
研究者
riham fathy galal
Lecturer of anesthesia, intensive care and pain medicine
Ain Shams University