A Comparative Study Between Ultrasound-guided Transversus Abdominis Plane Block Versus Ultrasound-guided Ilioinguinal-Iliohypogastric Nerve Block for Postoperative Analgesia Following Open Total Abdominal Hysterectomy: A Randomised Comparative Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Time to first rescue analgesia request
研究概览
简要总结
The investigators hypothesised that ultrasound-guided transversus abdominis plane (TAP) block would prolong the time to first rescue nalbuphine within 24 hours compared with ultrasound-guided ilioinguinal-iliohypogastric (IIH) nerve block, by virtue of its broader dermatomal coverage (T10-L1 versus T12-L1) of the Pfannenstiel incision. This hypothesis direction was established before unblinding and data analysis.
详细描述
Aim of the work
the aim of the study is to compare between the analgesic effect of Transversus Abdominis Plane Block and Ilioinguinal-iliohypogastric block following open abdominal hysterectomy Objectives
- to compare between the analgesic effect of Transversus Abdominis Plane Block and Ilioinguinal-iliohypogastric block For Postoperative Analgesia following open abdominal hysterectomy
- to measure the incidence of complications following both blocks as hematoma, block failure, infection at injection site
Sample size:
Our primary outcome is the time to first rescue analgesia request. In a previous study, the meantime to first rescue analgesia was 10.58 ± 2.35 hours (6). The investigators calculated a sample size that could detect a mean difference of 20% between both study groups. MedCalc Software version 14 (MedCalc Software bvba, Ostend, Belgium) was used to calculate the sample size.38 patients( 19 patients per group) at least were estimated to have a study power of 80% and an alpha error of 0.05. This number will be increased to 42 patients (21 patients per group) to compensate for possible dropouts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, operating surgeons, ward nursing staff, and outcome assessors were all blinded to group allocation, achieved through sealed-envelope concealment and separation of the block performer from all postoperative care and assessment. This represents an enhancement of blinding beyond the originally registered single-blinding.
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be adult patients (35-65 years)
- •ASA I-III
- •Scheduled for elective open TAH
排除标准
- •Patient refusal
- •BMI > 40 kg·m-²
- •Pregnancy
- •Chronic pain requiring daily analgesics
- •Any known allergy to local anesthetic, nalbuphine, paracetamol, or diclofenac
- •Patients with neurological, psychological disorders or those lacking cooperation
- •Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion.
- •Patients with bleeding disorders defined as (INR >2) and/ or (platelet count <100,000/µL)
- •Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement
研究组 & 干预措施
TAP Block
Transversus abdominus plane (TAP) block will be used as postoperative analgesia
干预措施: Transverse Abdominis Plane Block (Procedure)
IIIH Block
Ilioinguinal-iliohypogastric (IIIH) block will be used as postoperative analgesia
干预措施: Ilioinguinal-iliohypogastric block (Procedure)
结局指标
主要结局
Time to first rescue analgesia request
时间窗: Immediatly post operative for 24 hours
Time to first rescue analgesia request
Time to first rescue nalbuphine within 24 hours
时间窗: From end of surgery to first rescue dose within 24 hours postoperatively
Time from end of surgery to first administration of rescue nalbuphine (0.15 mg.kg-¹ intravenously, given when numerical rating scale pain score ≥ 4 at rest after 30 minutes).
次要结局
- Total nalbuphine consumption in each block (mg)(Immediate 24 hours post-operative)
- Intraoperative hemodynamics(At baseline, 5 minutes after intubation, every 10 minutes till the end of the surgery, immediately after extubation, 5 minutes after extubation, and every 10 minutes in PACU for 30 minutes till the discharge of the patient)
- Incidence of postoperative nausea and vomiting(Immediate 24 hours post-operative)
- VAS score(Immediate post-operative period every 5 minutes for the first 30 minutes , 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours.)
- Total nalbuphine consumption within 24 hours(Immediate 24 hours post-operative)
- Numerical Rating Scale (NRS)(5 minutes, 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours, 18 hours, and 24 hours after arrival in the post-anaesthesia care unit)
- Intraoperative and postoperative haemodynamics (heart rate and mean arterial pressure)(Baseline, every 10 minutes intraoperatively, immediately after extubation, 5 minutes after extubation, every 10 minutes in PACU for 30 minutes, then at 2, 4, 8, 12, 18, and 24 hours postoperatively)