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临床试验/CTRI/2021/06/034221
CTRI/2021/06/034221尚未招募不适用

Comparison of ultrasound guided transversalis fascia and transversus abdominis plane blocks for post-operative analgesia following lower segment cesarean section- A double blinded randomized control trial

Mahatma Gandhi Medical college and Research Institute1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年6月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
Assess the static and dynamic pain scores post-operatively

研究概览

简要总结

Cesarean section is one of the most commonly performed lower abdominal surgeries. Cesarean section pain has both somatic and dynamic components. Blocking both the components helps in reducing maternal morbidity, early mobilization and increased patient satisfaction.

The infra-umbilical of the anterior abdominal is supplied by T7- L1 nerves which travel in the Transversus abdominis plane (TAP). These nerves give lateral cutaneous branches which are blocked by posterior TAP (P-TAP) block. The lateral cutaneous branch of T 12 is spared in P-TAP but blocked in Transversalis fascia plane (TFP) block. Both the blocks have been studied and found useful in decreasing the opioid requirement.

This study will be started after obtaining institutional ethics committee approval and CTRI registration. Patients undergoing cesarean section under spinal anaesthesia in MGMCRI will form the study population. 90 patients will be sampled by continuous sampling and will be allocated into groups by permuted block randomisation.

Group 1: P-TAP block will receive 20 ml of 0.25% bupivacaine on either side in TAP

Group 2: TFP block will receive 20 ml of 0.25% bupivacaine on either side in TFP

Group 3: No intervention - will not receive any block

All patients will be given Inj. Paracetamol 1gm IV at the end of surgery and T. Paracetamol 650mg will be given at 6 hourly intervals for baseline analgesia

Static and dynamic pain scores will be assessed post-operatively for 24 hours and analgesic will be given when the dynamic score is more than 3. The time to first analgesic requirement, loss of sensation to touch and cold from T 10 to L4 dermatomes, the total 24 hour analgesic consumption will be noted.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Age 18 to 45 years, ASA II and III patients, BMI- 18-35 kg/m2.

排除标准

  • Allergy to local anaesthetic drugs, seizure disorder, if any intra-operative surgical complications, Prolonged duration of labour, if cesarean section is done under general anaesthesia.

结局指标

主要结局

Assess the static and dynamic pain scores post-operatively

时间窗: Static and dynamic pain scores will be assessed post-operatively for 24 hours at regular time intervals by asking the patient to flex their legs and by turning to one side

次要结局

  • Assessment of block dynamics(Loss of sensation to touch and cold will be assessed from T10 to L4 dermatomal levels)
  • Time to first analgesic requirement(Patients will be given analgesic when they give a pain score of more than 3)
  • Measurement of 24 hour cumulative rescue analgesic consumption(After administering the first analgesic, even after 30 minutes if the pain continues to persist then the second rescue analgesic will be administered and the 24 hour cumulative analgesic consumption will be noted)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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