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临床试验/CTRI/2024/10/075023
CTRI/2024/10/075023尚未招募不适用

Analgesic efficacy of wound infiltration with fentanyl or bupivacaine or bupivacaine with fentanyl in arthroscopic anterior cruciate ligament reconstructive surgery: A double blind randomized control trial

Sir Ganga Ram Hospital,New Delhi1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年10月20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
120
试验地点
1
主要终点
Postoperative pain evaluation during first 24 hours as assessed by VAS

研究概览

简要总结

Patients undergoing anterior cruciate ligament reconstructivesurgery commonly complain of high-intensity pain in the postoperative period due to tear of muscles and ligaments etc. Postoperative pain is the leading cause of prolonged hospital stay and delayed rehabilitation. Conventionally, postoperative pain relief in anterior cruciate ligament reconstructive surgery is achieved by using systemic analgesics, preferably opioids, which have their own set of deleterious effects like nausea, vomiting, pruritus, respiratory depression, and sedation etc. Epidural morphine has also been shown to be effective for pain relief but it needs technical expertise and its use is associated with side effects like sedation and respiratory depression. Local infiltrative analgesia is advantageous in terms of fewer side effects and ease of application, but its analgesic effect is short-lasting. Many local anaesthetic agentslike bupivacaine are being used as local infiltrative analgesiabut has limited duration of action (4-6 hours). The peripheral analgesic effect of fentanyl was reported long back and recent scientific evidence has finally unravelled the presence of activated opioid receptors at the incision site. Initial few studies have shown a promising analgesic effect and therefore, it has rekindled interest in local infiltration of fentanyl for its potent peripheral analgesic effect. Interestingly, the localinfiltration of fentanyl is devoid of the distressing side effects of systemic opioids as mentioned above.

We aim to conduct a double blind randomized controlled trial comprising of three groups with 35 patients in each group. Group â€˜B’ will be infiltrated with 10 ml of 0.25% bupivacainehydrochloride.  Group â€˜F’ will be infiltrated with 50 micrograms of Fentanyl citrate diluted in 10 ml of normal saline and Group â€˜BF’ will be infiltrated with 10 ml of solution containing 9ml of 0.25% bupivacaine hydrochlorideand 50 micrograms (1 ml) of fentanyl citrate at the surgical wound site in patients undergoing anterior cruciate ligamentreconstructive surgery under general anaesthesia. Post-surgery, we plan to assess pain relief with the help of visual analogue scale (VAS) and the total analgesic requirement of supplemental analgesic drugs will be recorded for 24 hours from infiltration of drug. Side effects of opioids namelynausea, vomiting and sedation will be assessed in all the threegroups. We anticipate that analgesic efficacy of fentanyl will be better than bupivacaine for wound infiltration in patients undergoing anterior cruciate ligament reconstructive surgeryunder general anaesthesia.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Physical Status: ASA grade I and II.

排除标准

  • Patients not giving consent.
  • Patient with neuropathy.
  • ASA III and more -History of hypersensitivity to the drugs under study -History of substance abuse.

结局指标

主要结局

Postoperative pain evaluation during first 24 hours as assessed by VAS

时间窗: At 2,4,12,24 hours

次要结局

  • Time of requirement of first rescue analgesia, Supplemental analgesic requirement & side effects like sedation, nausea, & vomiting(from time 0 to the onset of pain in 24 hours)

研究者

发起方
Sir Ganga Ram Hospital,New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Bhuwan Chand Panday

Sir Ganga Ram Hospital

研究点 (1)

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