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临床试验/CTRI/2024/07/070587
CTRI/2024/07/070587尚未招募不适用

Comparison between 0.25 percent of Bupivacaine and 0.25 percent of Ropivacaine with Dexamethasone in ultrasound guided femoral nerve block for post operative analgesia after total knee arthroplasty

Kasturba Medical College1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年7月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
1.Duration of action of block

研究概览

简要总结

Total knee replacement (TKR) is associated with significant postoperative pain. This postoperative pain is difficult to treat with oral analgesics, resulting in adverse endocrine, metabolic, and inflammatory responses . Single-injection femoral nerve block (FNB) significantly improves postoperative analgesia compared with systemic opioid therapy at least during the first 24 hours after TKR or ACL reconstruction  although some studies show a limited benefit of single-injection FNB as an analgesic technique during TKR or ACL reconstruction. The pain after TKA is severe and does not fade noticeably for 48–72 h after the surgery. Effective pain control allows for earlier ambulation and initiation of physiotherapy, which hastens recovery, A reduces the length of stay in the hospital, and lowers the risk of postoperative complications, such as thromboembolic dis- ease or nosocomial infections. Bupivacaine is the standard, long-acting local anaesthetic used in regional anaesthetic practice together with ropivacaine, a N-propyl homologue of bupivacaine and a pure S(-) enantiomer . Ropivacaine has shown a reduced potential for central nervous system toxicity and cardiotoxicity in laboratory experiments and in healthy volunteers . Total knee replacement (TKR) is associated with significant postoperative pain. This postoperative pain is difficult to treat with oral analgesics, resulting in adverse endocrine, metabolic, and inflammatory responses . Single-injection femoral nerve block (FNB) significantly improves postoperative analgesia compared with systemic opioid therapy at least during the first 24 hours after TKR or ACL reconstruction  although some studies show a limited benefit of single-injection FNB as an analgesic technique during TKR or ACL reconstruction.  The pain after TKA is severe and does not fade noticeably for 48–72 h after the surgery. Effective pain control allows for earlier ambulation and initiation of physiotherapy, which hastens recovery, A reduces the length of stay in the hospital, and lowers the risk of postoperative complications, such as thromboembolic disease or nosocomial infections. Bupivacaine is the standard, long-acting local anaesthetic used in regional anaesthetic practice together with ropivacaine, a N-propyl homologue of bupivacaine and a pure S(-) enantiomer . Ropivacaine has shown a reduced potential for central nervous system toxicity and cardiotoxicity in laboratory experiments and in healthy volunteers. Dexamethasone added to local anaesthetics (LAs) appears to prolong single-injection nerve block. The analgesic effects of spinal and systemic corticosteroids combined with LAs have proven to be effective in humans, whereas dexamethasone microspheres have increased block duration .

The purpose of the study is to compare difference in post operative analgesic duration, amount of sedation and systemic side effects in 0.25%bupivacaine and 4mg dexamethasone with 0.25% ropivacaine and adjuvant 4mg dexamethasone using femoral nerve block as a post operative analgesia in TKR

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • The patients undergoing total knee arthroplasty under regional anesthesia.
  • The patient falling in American society of anaesthesiology grade I ,II and III.
  • Age 30-80 yrs.

排除标准

  • Patients who are not willing to participate in the study.
  • Patient with a history of allergy to the drugs used in the study.Patients with infection at the site of subarachnoid block or femoral nerve block.
  • Patients with pre-existing peripheral neuropathy.
  • Patients with impaired renal and liver function, coagulopathy.
  • Patients with documented history of opioid sensitivity and/or allergy to NSAIDs.

结局指标

主要结局

1.Duration of action of block

时间窗: To assess motor blockade and VAS score after 30minutes, 1hour,2hours postoperatively

2.First time rescue analgesics consumed

时间窗: To assess motor blockade and VAS score after 30minutes, 1hour,2hours postoperatively

3.Total amount of rescue analgesia consumed

时间窗: To assess motor blockade and VAS score after 30minutes, 1hour,2hours postoperatively

4.Time taken for ambulation post surgery

时间窗: To assess motor blockade and VAS score after 30minutes, 1hour,2hours postoperatively

次要结局

  • To assess duration taken for ambulation of patient postoperatively.

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Angela Abraham

Kasturba Medical College, Mangalore

研究点 (1)

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