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临床试验/NCT05442411
NCT05442411已完成1 期

Regional Scalp Block Versus IV Parecoxib for Post-operative Cranioplasty Surgery Pain: A Comparison of Pain Score.

Universiti Sains Malaysia1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2021年3月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
58
试验地点
1
主要终点
pain score

研究概览

简要总结

To compare the post cranioplasty pain score using scalp block versus conventional analgesia using IV Parecoxib and requirement of morphine between two groups as rescue analgesia

详细描述

This study involved a prospective, double-blinded randomized controlled trial which has been approved by the Medical Research and Ethics Committee (JEPEM) of Universiti Sains Malaysia (JEPeM Code: USM/ JEPeM/19100637).

Fifty-eight patients with written informed consent and American Society of Anaesthesiologist (ASA) physical status I and II, aged 18 to 60 years old, pre-operative GCS of 15 and underwent elective cranioplasty surgery under general anaesthesia (GA) between September 2019 until March 2022 were selected for the study and randomized by computer generated randomization into two groups; Regional Scalp Block (n = 29) and IV Parecoxib (n = 29). The patients were excluded from this study if they were a known allergy to local anesthesia or NSAIDS, had risk for bleeding tendency or coagulopathy, low preoperative platelets count (< 100 x103/mL) or with underlying bronchial asthma. The patient withdrawn from the study if he or she was not able to score post pain using Visual analog Scale (VAS) or had redo surgery for postoperative bleeding.

During surgery, all of them were induced by standard anaesthesia protocol. They were given IV fentanyl 1-2mcg/kg, IV propofol 2 mg/kg and IV rocuronium 0.6mg /kg. The anaesthesia was maintained with sevoflurane with minimum alveolar concentration (MAC) of 1.0 to 1.2 with mixture of air and oxygen. The intraoperative analgesia were IV Fentanyl 1-2mcg/kg and IV paracetamol 1g. The total intraoperative analgesia dose was recorded in GA form and the top-up muscle relaxant was given as needed upon evidence of rebreathing in the capnograph waveform. At the end of the surgery, all subjects were reversed with IV neostigmine 0.05 mg/kg and atropine 0.02mg/kg.

The injection solution for both groups were prepared by the single anaesthesiologist who are experience and familiar with scalp block procedure and IV Parecoxib. For the Group A, they were given regional scalp block by using solution 0.375% ropivacaine and lidocaine 1% up to 20 ml. The same person was performed the Scalp Block by injecting the solution into Supra-orbital & Supratrochlear (V1), Auriculo-temporal (V2), Post-auricular branches of the Greater Auricular Nerves and Occipital nerves after the surgeon completed skin closure of the scalp at the end of surgery (at the side that will be operated). Group B was injected IV parecoxib 40mg during the closure of the scalp. All subjects will be reversed using standard reversal and fulfil criteria for extubation before extubation Post cranioplasty operation, both groups were given PCA Morphine as rescue analgesia if pain score ≥ 4. Both groups received IV paracetamol 1g 6 hourly as additional analgesia.

Pain score was assessed by staff nurses in the ward (unrelated to study to avoid bias) by using visual analogue scale (VAS) at interval hours of first, second, forth, sixth and twelfth-hour post cranioplasty. The patient was withdrawn from the study if they had massive bleeding or hemodynamically unstable or require intensive care and ventilatory support post cranioplasty. The patients and post-operative assessors (the staff nurse in the ward) were blind to avoid bias.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

participant is blineded to the treatment as they was givemn intraopeartively the pain score assessor is blinded since the assessment was done postoperatively

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

post operative pain score

Experimental

post operative pain score at 1hour, 2 hour, 4 hour, 6 hour, and 12 hour

干预措施: Ropivacaine 0.75% Injectable Solution (Drug)

morphine requirement

Experimental

post operative PCA morphine requirement

干预措施: Ropivacaine 0.75% Injectable Solution (Drug)

结局指标

主要结局

pain score

时间窗: 12 hours

visual analog score

次要结局

  • total morpine requirement(12 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamad Hasyizan Hassan

Senior Lecturer and Neuroanaesthesiologist

Universiti Sains Malaysia

研究点 (1)

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