Regional Scalp Block Versus IV Parecoxib for Post-operative Cranioplasty Surgery Pain: A Comparison of Pain Score.
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1

Summary: 
      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
    

Detailed description: 
      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 The patient withdrawn from the study if he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.

      After 12 hours, the total requirement of morphine and time for request rescue analgesia were
      recorded. The side effects of both methods were documented. Local anesthesia side effects
      such as allergic reactions, local tissue, cardiovascular, central nervous system, and
      systemic toxicity, infection, changes in wound healing, or increased wound drainage.
      Parecoxib side effects such as bleeding, renal failure, and myocardial infarction.

      The sample size was calculated using the G*Power Software (Version 3.1.9.7 by Franz Faul,
      Universitat Keil, Germany. Based on the objective to compare effectiveness in pain control
      between both groups using effect size f 0.30, power of 0.8, ɑ error probability 0.05, number
      of groups 2 and number of measurements 5. It required 21 peoples in one group and a total
      sample size of 42. These included a 10% dropout.

      Data were analysed using IBM SPSS statistics version 26 software. All measurement data were
      analysed for normal distribution and homogeneity variance. All demographic data between
      groups were analysed using descriptive analysis and independent sample t-test for numerical
      data and Chi-square analysis for categorical data. Differences in pain score using VAS
      between two groups were analysed using one-way and two-way repeated ANOVA. Model assumptions
      of normality and homogeneity of covariance were checked. Total morphine requirement and the
      first time PCA were analysed using an independent sample t-test. The side effects of both
      groups were analysed using the Chi-Square test. A P -the value of < 0.05 was regarded as
      statistically significant.
    

Intervention name(s): Ropivacaine 0.75% Injectable Solution
Intervention type(s): Drug
Intervention description(s): comparison of scalp block vs conventional post operative parecoxib
Other intervention name(s): parecoxib 40mg
Intervention MeSH terms: Parecoxib; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomised contrrolled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment