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临床试验/CTRI/2024/12/078420
CTRI/2024/12/078420尚未招募不适用

Comparison of Dexamethasone and Magnesium sulphate as adjuvants to Ropivacaine in ultrasound guided transversus abdominis plane block for post operative analgesia in patients undergoing Total Abdominal Hysterectomy: A Randomized Controlled Trial.

N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月1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
60
试验地点
1
主要终点
To compare post operative analgesia of Dexamethasone and Magnesium sulphate as an adjuvant to Ropivacaine in ultrasound guided transversus abdominis plane block in Total Abdominal Hysterectomy in terms of

研究概览

简要总结

Postoperative analgesia aims to reduce the negative consequences of acute postsurgical pain and help the patient transition smoothly back to normal function. Acute postoperative pain without adequate management leads to persistent postsurgical pain or chronic pain.  Regional anaesthesia provides site specific, effective and long lasting anaesthesia.  Some of the abdominal nerve blocks are transversus abdominis plane, subcostal, rectus, ilioinguinal and iliohypogastric, transversalis fascia plane, and quadratus lumborum block. Transversus abdominis plane block is a peripheral nerve block that blocks sensation to anterior and lateral abdominal wall as well as the parietal peritoneum. The TAP anatomical compartment is located between the internal oblique and transversus abdominis muscles and contains the T6 to L1 thoracolumbar nerves.  The T9 to T11 Intercostal and T12 Subcostal (SC) nerves penetrate the transversus abdominis plane compartment posterior to the midaxillary line. It is one of the most common truncal block for post operative analgesia in lower abdominal surgeries because of its easy accessibility, safety and reliability. Ropivacaine, an enantiomer of Bupivacaine, is a long-acting amide and less likely to penetrate large myelinated motor fibers so it has relatively shown lesser motor blockade with safer cardiac profile used for peripheral nerve block. Addition of adjuvant improves the efficacy of local anaesthetics by reducing the duration of onset of action, prolonging the duration of action, decrease pain intensity and reduce consumption of systemic opioids and lesser systemic side effects. Dexamethasone is a highly potent, long acting glucocorticoid. It acts by inhibiting    potassium conductance by binding to glucocorticoid receptors which decreases  the activity of nociceptive C-fibres and may also prolong the analgesia duration through systemic anti-inflammatory effects and local vasoconstrictive action. Magnesium sulphate is an N-methyl D-aspartate (NMDA) receptor antagonist. It is a non-competitive antagonist which blocks the voltage- dependent ion channels. This receptor is found in many parts of the body, including the nerve endings and plays a role in modulating inflammatory responses and pain responses by preventing central sensitisation caused by peripheral nociceptive stimulation. Hence, the aim of this study is to compare the efficacy of Dexamethasone versus Magnesium sulphate with Ropivacaine in ultrasound guided transversus abdominis plane(TAP) block for patients undergoing Total Abdominal Hysterectomy.

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
35.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • Patients scheduled for elective Total Abdominal Hysterectomy surgery under subarachnoid block.
  • American Society of Anaesthesiologists (ASA) physical status 1 and
  • Patients giving consent for study.
  • BMI less than 30 kg/m3.

排除标准

  • Bleeding disorders.
  • History of cardiac, renal, respiratory or hepatic disease.
  • Allergy to study drugs.

结局指标

主要结局

To compare post operative analgesia of Dexamethasone and Magnesium sulphate as an adjuvant to Ropivacaine in ultrasound guided transversus abdominis plane block in Total Abdominal Hysterectomy in terms of

时间窗: 1)Post-operative pain assessment will be done by Numerical Rating score (NRS) at 0,1,2,4,6,12 and 24 hours after surgery. | 2) Time of requirement of first rescue analgesia. | 3) Total analgesic doses required in first 24 hours. | 4) Total number of rescue analgesia will be calculated in 24 hours. | 0 Hours will be taken as the time of block

1) Numerical rating scale (NRS) for pain assessment.

时间窗: 1)Post-operative pain assessment will be done by Numerical Rating score (NRS) at 0,1,2,4,6,12 and 24 hours after surgery. | 2) Time of requirement of first rescue analgesia. | 3) Total analgesic doses required in first 24 hours. | 4) Total number of rescue analgesia will be calculated in 24 hours. | 0 Hours will be taken as the time of block

2) Time of requirement of first rescue analgesia.

时间窗: 1)Post-operative pain assessment will be done by Numerical Rating score (NRS) at 0,1,2,4,6,12 and 24 hours after surgery. | 2) Time of requirement of first rescue analgesia. | 3) Total analgesic doses required in first 24 hours. | 4) Total number of rescue analgesia will be calculated in 24 hours. | 0 Hours will be taken as the time of block

3) Total analgesic doses required in first 24 hours

时间窗: 1)Post-operative pain assessment will be done by Numerical Rating score (NRS) at 0,1,2,4,6,12 and 24 hours after surgery. | 2) Time of requirement of first rescue analgesia. | 3) Total analgesic doses required in first 24 hours. | 4) Total number of rescue analgesia will be calculated in 24 hours. | 0 Hours will be taken as the time of block

次要结局

  • To compare side effects of Dexamethasone and Magnesium sulphate as an adjuvant to Ropivacaine in ultrasound guided transversus abdominis plane block in Total Abdominal Hysterectomy with respect to :

研究者

发起方
N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital.
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Mrunal Bharsakale

N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital.

研究点 (1)

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