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临床试验/CTRI/2024/04/065963
CTRI/2024/04/065963尚未招募4 期

A randomized double blinded comparative interventional study to assess the post operative analgesic effect of Magnesium sulphate versus Dexamethasone as adjuvants to Bupivacaine in ultrasound guided Transversus Abdominis Plane Block in open unilateral hernia surgeries

SMS Medical College and attached hospitalls1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2024年4月29日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
105
试验地点
1
主要终点
1 To assess and compare the mean dose of rescue analgesic requirement in first 24 hours conferred by bupivacaine with magnesium sulphate versus bupivacaine with dexamethasone in USG guided TAP block in open unilateral hernia surgeries

研究概览

简要总结

Inguinal hernia is one of the most commonly performed surgical procedures which is associated with moderate to severe intensity of pain that is at its most extreme in the first 24 hours post surgery. Inadequate pain relief in these patients can lead to delayed recovery extended duration of hospital stays and also lead to persistent pain after surgery

Abdominal field blocks and costo iliac block have been used in anaesthesia for surgery involving the anterior abdominal wall for severe decades through innervation of the anterior abdominal wall arises from the spinal nerves T7 to L1. The aim of TAP block is to deposit  local anaesthetic in the plane between  internal oblique and Transversus abdominis muscle. By blocking  these nerves, the innervation to abdominal skin, muscles and parietal peritoneum can be interrupted. The somatic component is blocked and aids in decreased consumption of opioid in 24 hours after surgery as opioid causes nausea, constipation and urinary retention as well as negative consequences such as respiratory depression, hormonal , sedation and post operative ileus. Various adjuvants have been used with local anaesthetics to improve the quality and duration like Dexamethasone, magnesium sulphate, adenosine and buprenorphine ,dexmedetomidine in TAP block to prolong the analgesic action in lower abdomen

Bupivacaine is a long acting aminoamide local anaesthetic agent. Chemically Bupivacaine is a racemic  mixture  of levo  and dextro  isomers. It blocks impulse conduction in nerve fibres via reversible of sodium influx and it has more action on A and C fibres which are meant for pain transmission

Magnesium sulphate is a N methyl D aspartate  antagonist. It  acts by non competitive antagonism blocks the voltage dependent ion channel . It blocks calcium influx which inhibits central sensitisation and decrease pre existing pain hypersensitivity and provides better post operative analgesia

Dexamethasone is a long acting glucocorticoid . It inhibits potassium conductance by binding to receptors which decrease the activity of nociceptive Cfibres and prolong the duration of  analgesia through anti inflammatory effects and local vasoconstrictive action

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients consenting to participate between age 18-60 years undergoing elective open unilateral hernia surgeries under spinal anaesthesia.
  • Patients belonging to ASA grade I and II.
  • Weight between 40-80 kgs.

排除标准

  • Patients not consenting to participate Patients having history of chronic use of analgesia for pain Patients allergic to drugs used in the study Patients with psychosis or gross neurological disorders Patients with body mass index more than 35.

结局指标

主要结局

1 To assess and compare the mean dose of rescue analgesic requirement in first 24 hours conferred by bupivacaine with magnesium sulphate versus bupivacaine with dexamethasone in USG guided TAP block in open unilateral hernia surgeries

时间窗: 1 To assess and compare the mean dose of rescue analgesic requirement in first 24 hours conferred by bupivacaine with magnesium sulphate versus bupivacaine with dexamethasone in USG guided TAP block in open unilateral hernia surgeries | 2 To assess and compare NRS scores between two groups | 3 To assess and compare the level of patient satisfaction betweeen two groups using patient satisfaction index

2 To compare and assess NRS scores between two groups

时间窗: 1 To assess and compare the mean dose of rescue analgesic requirement in first 24 hours conferred by bupivacaine with magnesium sulphate versus bupivacaine with dexamethasone in USG guided TAP block in open unilateral hernia surgeries | 2 To assess and compare NRS scores between two groups | 3 To assess and compare the level of patient satisfaction betweeen two groups using patient satisfaction index

3 To assess and compare the level of patient satisfaction betweeen two groups using patient satisfaction index

时间窗: 1 To assess and compare the mean dose of rescue analgesic requirement in first 24 hours conferred by bupivacaine with magnesium sulphate versus bupivacaine with dexamethasone in USG guided TAP block in open unilateral hernia surgeries | 2 To assess and compare NRS scores between two groups | 3 To assess and compare the level of patient satisfaction betweeen two groups using patient satisfaction index

次要结局

  • 1.To determine and compare the difference in hemodynamic(( heart rate, systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, spo2) differences in both groups.)

研究者

发起方
SMS Medical College and attached hospitalls
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Anupama Gupta

SMS Medical College

研究点 (1)

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