COMPARISON OF TRANSVERSUS ABDOMINIS PLANE BLOCK ANDQUADRATUS LUMBORUM PLANE BLOCK FOR POST OPERATIVEANALGESIA FOLLOWING CAESAREAN DELIVERYA PROSPECTIVE RANDOMISED SINGLE BLINDED STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Total number of rescue analgesics used for 24 hours.
研究概览
简要总结
After obtaining Informed consent, patient who fit into inclusion criteria will be enrolled into the study.
All patient’s assessment will be done on previous day and nil per oral orders will be
given as per department protocol.
Baseline Blood Pressure and heart rate will be recorded before shifting to
operating room. After shifting to operating room electrocardiography, noninvasive
blood pressure, and oxygen saturation will be connected. An 18G iv
line would be secured, following which patients will receive Spinal anaesthesia
with 0.5% heavy bupivacaine using 27G Pencan Needle. Intraoperatively heart
rate, non-invasive blood pressure, Spo2 will be monitored every 10 to 15
minutes.
Patient will be randomized to one of the groups using computer generated
random number.
Group A - Patients undergoing Transversus Abdominis Plane Block
Group B – Patients undergoing Quadratus Lumborum Block
The allocated group to which the patient belongs would be informed to the anaesthesiologist performing
the block prior to shifting the patient inside the Operating room.
At the end of the conduct of Caesarean section the allocated block would be
performed by the anaesthesiologist
Both groups will receive
0.4ml/kg 0.125% Bupivacaine +0.5mcg/kg Dexmedetomidine on either side using
Linear probe of bedside USG machine (Sonosite R ultrasound system, Sonosite
INC,)
After administering the block, the patient would be shifted to Post Anaesthetic
Care Unit and later to the ward and observed by staff nurses for who are blinded
regarding the type of block given to the patient for 24 hours.
When VAS >4, the rescue analgesia (Tramadol 50mg IV) will be given and
time noted by the Staff nurses
PARAMETERS OBSERVED:
Pain levels assessed using Visual Analogue Scale (VAS), Heart rate, Blood
Pressure (SBP/DBP) and SpO2 are noted at 0 minute, 30 minutes, 1 hour, 2
hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours from the
time of administration of the block by the staff nurses in the PACU and ward.
Time to first rescue analgesic (Tramadol 50mg IV) from the time of
administration of block.
Patient will continue to be observed in PACU and WARD for total rescue
analgesia up to 24 hours from the time of administration of the block
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)(—)
- 性别
- Female
入选标准
- •1.Pregnant Patients ASA II
- •Normal Singleton Pregnancy – Gestational Age ≥ 37weeks
- •Elective Caesarean Section under Subarachnoid block.
排除标准
- •Patient Refusal
- •Emergency Lower segment Caesarean Section
- •Coagulation or Bleeding disorders
- •Anatomical abnormalities at block site
- •Allergy to study drug
- •Inability to comprehend or participate in the pain scoring.
结局指标
主要结局
Total number of rescue analgesics used for 24 hours.
时间窗: 0 minute, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours from the | time of administration of the block.
次要结局
- Intensity of postoperative pain recorded through Visual Analogue Score(0 minute, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours from the)
- Time to initial onset of pain (VAS 4) and time to first rescue analgesia.(0 minute, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours from the)
