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临床试验/CTRI/2018/08/015463
CTRI/2018/08/015463已完成4 期

Post-Operative Analgesic Effect of Bupivacaine alone and with Dexmedetomidine in Wound Instillation for Lumbar Laminectomy: A Randomised Control Trial

Department of Anaesthesia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年1月9日最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
. post operative pain score.

研究概览

简要总结

Background: Dexmedetomidine has been used as an effective adjuvant to local anaesthetics in peripheral nerve blocks and at incision site. We studied the effect of addition of dexmedetomidine as an adjuvant to bupivacaine in wound instillation for postoperative analgesia. Aims To compare the postoperative analgesic effect of bupivacaine alone and in addition of dexmedetomidine to bupivacaine in wound instillation for lumbar laminectomy.

Study Design: Prospective, randomised, double blind study.

Methodology: Sixty adults of ASA grade I-II scheduled for elective lumbar laminectomy under general anaesthesia were randomly allocated into two groups. Group B(control group) patients received wound instillation with 20ml of 0.25% bupivacaine at the end of surgery and Group D patients received 2μgm.kg-1dexmedetomidine diluted in 20 ml 0.25% bupivacaine as instillation over incision site. If the NRS exceeded ‘4’ at any point of time, rescue analgesia with inj. Diclofenac 75 mg deep intramuscular was administered. Post- operative pain score, duration of analgesia, total rescue analgesic required in 24 h, incidence of side effects such as bradycardia, hypotension, sedation, nausea and vomiting were compared between the groups.

Results: Dexmedetomidine group has better pain score, longer duration of effective analgesia, lower percentage of patients requiring rescue analgesic and less no of doses of rescue analgesic required in first 24 h.

Conclusion: We conclude that dexmedetomidine 2µg.kg-1 is an effective adjuvant to bupivacaine for wound instillation in terms of quality and duration of postoperative analgesia following lumbar laminectomy.

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status I and II.
  • Age 18 to 60yrs of either sex,
  • Scheduled for lumbar laminectomy under general anaesthesia.

排除标准

  • 1.Patients with spinal stenosis, 2.Planned to have multiple level or double site laminectomy, 3.Patients who underwent prior lumbar disc surgery, 4.Have ASA III-IV status, 5.Prior neurological deficits, 6.Preoperative opioid use or any history of substance abuse or on steroids, 7.Have known local anaesthetics allergy, 8.Bleeding, cerebrospinal fluid leak, or requiring placement of a drain.

结局指标

主要结局

. post operative pain score.

时间窗: 0 hr ,every 1 h till 8 hrs and then every 6 hrs till 24 hrs

Duration of analgesia, total analgesic requirement and pain score in 24 hours will be recorded.

时间窗: 0 hr ,every 1 h till 8 hrs and then every 6 hrs till 24 hrs

次要结局

  • vital parameters of patients.(side effects if any)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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