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临床试验/CTRI/2020/01/022813
CTRI/2020/01/022813已完成4 期

A randomized controlled study comparing the ultrasound-guided Transversalis fascia plane block and standard multimodal analgesia technique utilizing wound infiltration for post-caesarean pain management and mRNA expression of OXTR gene

University College Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月20日最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
To determine and compare the time to first request of analgesia between the two groups

研究概览

简要总结

The present randomized controlled study aims to compare the ultrasound-guided Transversalis fascia plane block and standard multimodal analgesia technique utilizing wound infiltration for post-caesarean pain management and comparison of mRNA expression of OXTR gene between the two groups. Standard anaesthetic technique for subarachnoid block will be adopted in all patients undergoing caesarean section. Patients will be randomized into two groups. A total of 60 patients with 30 patients in each group will be recruited, in Group C, patients will receive standard multimodal analgesia including wound infiltration (20 ml of 0.375% ropivacaine) at the end of the surgery and patients in group-T, will receive bilateral Ultrasound-guided Transversalis fascia plane block (20 ml of 0.375% ropivacaine) at the end of the surgery. In both the groups, exogenous oxytocin administration after the baby delivery and post operative analgesia will be done as per the standard protocol. Patient’s pain assessment will be done at various designated intervals till 14th week. Blood sample will be withdrawn at baseline and at the end of 14th week for gene expression study. The primary objective is to determine and compare the time to first request of analgesia between the two groups  The Secondary Objectives are to determine and compare the NRS pain score at rest and movement at 1st, 6th, 12th, 24th hours and at the end of 6th, 10th and 14th week, total consumption of rescue analgesic in the first 24 hours, Pain detect questionnaire (PDQ) score and Neuropathic pain symptom inventory (NPSI) score and the quality of life using short form (SF)-12 questionnaire at the end of 6th, 10th and 14th week and incidence of chronic persistent post-surgical pain (CPSP) at the end of 14th week. Comparison of mRNA expression of OXTR genes will be done between the two groups at baseline and then at the end of 14th week.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant 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

  • Patients of ASA grade I or II undergoing lower segment caesarean section with pfannenstiel incision under subarachnoid block.

排除标准

  • Patients having other causes of chronic pain,Patients having cognitive dysfunction or inability to comprehend various questionnaires, Patients having chronic neurological disorders/substance abuse,body mass index (BMI) > 40 kg/m2.

结局指标

主要结局

To determine and compare the time to first request of analgesia between the two groups

时间窗: The Time to first request of analgesia will be measured from completion of the intervention i.e. wound infiltration or abdominal plane block following the completion of surgery till the patients first demand for analgesia

次要结局

  • NRS pain score at rest and movement,(Total consumption of diclofenac in 24 hours, Pain detect questionnaire (PDQ), NPSI scores, SF-12 score,)

研究者

申办方类型
Government medical college

研究点 (1)

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