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临床试验/CTRI/2024/10/074759
CTRI/2024/10/074759已完成不适用

Effect of oral versus intravenous dexamethasone on duration of analgesia after osseous upper limb surgery under supraclavicular brachial plexus block

Maulana Azad Medical College1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年10月18日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Duration of analgesia

研究概览

简要总结

This prospective, randomized, double-blind controlled trial evaluates methods to prolong postoperative analgesia following ultrasound-guided supraclavicular brachial plexus block (SBPB) for upper limb orthopedic surgery. Adult ASA I–III patients undergoing unilateral forearm or hand osseous surgery will be randomized to receive either oral dexamethasone 12 mg two hours before surgery with intravenous placebo, or intravenous dexamethasone 8 mg at the time of block with oral placebo. All patients will receive oral etoricoxib 90 mg preoperatively as part of a standardized multimodal analgesic regimen.

SBPB will be performed using ropivacaine in all patients. The primary outcome is the duration of analgesia, defined as time to first postoperative pain requiring rescue analgesia. Secondary outcomes include postoperative pain scores, quality of recovery, and adverse effects. The study aims to determine whether oral dexamethasone provides analgesia comparable to intravenous dexamethasone.

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

  • adult patients between the age of 18-60 years scheduled to undergo elective upper limb orthopaedic surgery under supraclavicular brachial plexus block patients belonging to Amercian Society of Anaesthesiologists(ASA) PHYSICAL STATUS I.

排除标准

  • Any contraindications to supraclavicular brachial plexus block (deformity of shoulder, coagulopathy, local skin infection, bleeding diathesis).
  • History of hypersensitivity to study drug.
  • History of alcohol abuse, chronic analgesic drug therapy, psychoactive drug use
  • Significant cognitive or psychiatric illness.
  • Known case of diabetes mellitus.
  • Pre-existing nerve disease or neuropathy in upper limb.
  • Pregnant or lactating women.

结局指标

主要结局

Duration of analgesia

时间窗: Pain score in the patient will be assessed in the post operative room immediately after the surgery and at 2,6,12,24 hours

次要结局

  • Duration of motor blockade(Time from completing administration of supraclavicular brachial plexus block to first report of restoration of finger movement in the individual)
  • Post op pain scores(Pain scores at 0, 6, 12 and 24 hours after surgery according to NRS method)
  • Average post op pain score(Taking the mean of NRS score at 0, 6,12 and 24 hours)
  • Recovery quality after the 24 hours(QOR-15 quality of recovery score to be done at 24 hours)
  • Analgesic consumption over first 24 hours(Total consumption of the patient in the first 24 hours post operatively will be noted)

研究者

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

Akshay Sharma

Maulana Azad Medical College

研究点 (1)

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