Effect of Nerve Block Versus General Anaesthesia for Distal Radial Fracture Surgery
Condition: Acute Pain
MeSH terms: Acute Pain; Radius Fractures
Study type: Interventional

Summary: 
      This study aims to investigate whether infraclavicular nerve block improves acute
      postoperative pain after distal radial fracture surgery.
    

Detailed description: 
      A single blinded randomized control trial will be performed to compare regional anaesthesia
      with single shot infraclavicular nerve block versus general anaesthesia.

      The primary outcome was postoperative NRS pain score (0-10) with movement at 24 hours after
      surgery. No suitable references for postoperative NRS pain scores at 24 hours that could be
      used for sample size calculation was found. Based on a previous study on RA versus GA for
      hand surgery, the standard deviation estimate of the treatments for sample size calculation
      was 2.86. To detect a difference in NRS pain score of 2.4/10 at a significance level of 0.05
      and a power of 0.80, the minimum number of patients required per group was 23. A difference
      of 2.4 in NRS pain score was chosen because this has been shown to correspond to 'much
      improvement' in pain relief, which is clinically significant. To take into account for
      possible dropouts, 26 patients were recruited into each group.

      Patients will be approached in the general ward before operation. The aims of the study and
      need for follow up assessment would be explained and patient will be recruited only if s/he
      agrees. After agreeing to join the study, patients will be randomly allocated to one of two
      groups: 1) General anaesthesia (GA) 2) Regional Anaesthesia with infraclavicular block (RA).
      Outcomes of patients in receiving general anaesthesia (GA) will be compared with patients
      receiving infraclavicular nerve block (RA).

      Data Analysis Intention-to-treat will be used. Patients will remain in their initial
      designated groups for data analysis even if there is a change in surgical or
      anaesthetic/analgesic management, as long as they are undergoing distal radial fracture
      surgery not involving another operative site (eg bone graft). Patients in the RA group who
      required conversion to general anaesthesia due to inadequate infraclavicular block would
      remain in the RA group for data analysis.

      Statistical methods used:

        -  Incidence of chronic post surgical pain: Chi-Square test

        -  NRS pain scores at 3 and 6 months after surgery: Mann-Whitney test to look at difference
           in mean pain scores between two groups

        -  duration of anaesthetic, analgesic and surgical procedures, time to extubation,
           cumulative opioid consumption, dose and frequency of rescue analgesic used, time to food
           intake and ambulation, time to discharge, patient satisfaction: Kruskal-Wallis test

        -  Acute NRS pain scores over 48 hours: Postoperative NRS pain scores were expressed in
           median (interquartile range) and analyzed using Mann-Whitney U test with post-hoc
           multiple comparisons using Bonferroni procedure

        -  Patient demographic data: One way ANOVA and chi-square test.

        -  Intraoperative vital signs, HRQOL, HADS, DASH-HKPWH: Repeated measures ANOVA (with
           Bonferroni correction when appropriate)

        -  Side effects and postoperative complications: Chi Square test

        -  When a significant result is obtained, t-test or Mann-Whitney test for numerical values
           and Chi-square test for categorical data will be applied for post hoc pairwise
           comparisons.
    

Intervention name(s): Infraclavicular nerve block; General anaesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): Infraclavicular nerve block is a relatively safe and straightforward brachial plexus nerve block that can be used to provide intraoperative regional anaesthesia for upper limb surgeries from the elbow to fingers.; Usual practice for upper limb surgeries.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Nerve block; Infraclavicular; Acute pain