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
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
Dr Anupama Gupta
SMS Medical College
