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临床试验/CTRI/2021/01/030289
CTRI/2021/01/030289已完成不适用

COMPARISON OF TRANSVERSUS ABDOMINIS PLANE BLOCK ANDQUADRATUS LUMBORUM PLANE BLOCK FOR POST OPERATIVEANALGESIA FOLLOWING CAESAREAN DELIVERYA PROSPECTIVE RANDOMISED SINGLE BLINDED STUDY

Kiran Muthu Rajah1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2021年1月15日最近更新:

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)

研究者

发起方
Kiran Muthu Rajah
申办方类型
Other [self]

研究点 (1)

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