跳至主要内容
临床试验/CTRI/2024/10/074709
CTRI/2024/10/074709尚未招募不适用

Comparison of transversalis fascia plane block versus ilioinguinal-iliohypogastric nerve block for postoperative analgesia in patients undergoing caesarean section

Dayanand Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年10月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Total rescue analgesic requirement

研究概览

简要总结

Caesarean section is associated with moderate-to-severe postoperative pain. Effective postoperative analgesia after LSCS is essential for early breast feeding and ambulation and has a role to play in decreasing postpartum depression. Transversalis fascia plane (TFP) block and ilioinguinal-iliohypogastric (ILIH) nerve block are regional anaesthesia techniques that have the potential to improve analgesia following caesarean section. This study will help us to determine which block has superior pain management properties.

A prospective, randomized, interventional study will be conducted in 80 American Society of Anaesthesiologists grade II parturients scheduled for elective caesarean section with Pfannenstiel incision under SAB, divided into two groups of 40 each. In group T, TFP block and in group I, ILIH block will be administered using 40 ml of 0.2% ropivacaine with 4mg dexamethasone (20 ml on each side) after completion of caesarean. The surgical site wound infiltration will be done with 10 ml of 0.2 % ropivacaine in both the groups. Postoperatively, monitoring of vitals and assessment of pain will be conducted using Numerical Rating Scale (NRS). Any patient complaining of NRS ≥ 4 will be administered rescue analgesic (Injection tramadol 50mg intravenously). The patient satisfaction score for pain management will be determined by five-point Likert scale. The total rescue analgesic consumption in 24 hours will be compared as a primary outcome and NRS scores, time to first rescue analgesic and patient satisfaction score will be compared for secondary outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Parturients under American Society of Anaesthesiologists (ASA) class II who are scheduled for elective caesarean section with Pfannenstiel incision under subarachnoid block.

排除标准

  • 1.Infection at injection site 2.Patient with known allergy to any of the study drug 3.Coagulation disorder with INR more than 1.5 4.ASA class III and IV patients.
  • 5.Twin pregnancy 6.Emergency caesarean section 7.Placenta previa and accreta 8.Chronic opioid abuse 9.Patient refusal.

结局指标

主要结局

Total rescue analgesic requirement

时间窗: In the first 24 hrs

次要结局

  • Assessment of NRS scores at predefined intervals(At 0, 2, 4, 6, 8, 12, 16, 20, 24 hours)
  • Time to first rescue analgesic(In the first 24 hrs)
  • Patient satisfaction score for pain management(At 24 hrs)

研究者

发起方
Dayanand Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Neeru Luthra

Dayanand Medical College and Hospital, Ludhiana

研究点 (1)

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