Effect of Dexmedetomidine on the Quality of Recovery in Parturients Undergoing Elective Caesarean Sections
Condition: The Quality of Recovery (ObsQOR-11)
Study type: Interventional
Phase: Phase 4

Summary: 
      The study hypothesizes that addition of dexmedetomidine to bupivacaine either in spinal
      anesthesia or TAP block is more effective and provide better ObsQor-11score than bupivacaine
      alone. Also, Dexmedetomidine in TAP block might provide a longer pain free time in comparison
      to intrathecal dexmedetomidine.
    

Detailed description: 
      Aim of the work To compare the quality of recovery (ObsQOR-11) in patients undergoing
      cesarean sections receiving dexmedetomedine either intrathecally or in the tap block in
      comparison to patients receiving conventional spinal anesthesia and tap block.

      Statistical Analysis I. Sample size In a pilot study on 5 parturient who had undergone
      elective cesarean section under spinal anesthesia followed by TAP block with bupivacaine
      alone, the mean ObsQoR-11 at 24 hours was 65±9. In a single factor ANOVA study, sample size
      of 126 from the 3 groups is needed to detect a difference of at least 10 using the
      Tukey-Kramer (Pairwise) multiple comparison with study power of 83% and alpha error of 0.05.
      The common standard deviation within a group is assumed to be 9. The number of envelopes will
      be increased to 141 (47 per group) to compensate of possible 10% dropout. The sample size was
      calculated using PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC.
      Kaysville, Utah, USA, ncss.com/software/pass.

      II. Statistical analysis Data will be coded and entered using the statistical package SPSS
      (statistical package for the social science) version 22. Data will be summarized using mean,
      standard deviation, median, minimum and maximum in quantitative data and using frequency
      (count) and relative frequency(percentage)for categorical data. Comparisons between
      quantitative variables will be done using the non parametric Mann-Whitney test. For comparing
      categorical data, Chi square (x2 ) test will be performed. Exact test will be used instead
      when the expected frequency is less than 5. P-value less than 0.05 will be considered as
      statistically significant.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): All patients will be assessed clinically and investigated for exclusion of any of the above-mentioned contraindications. The required laboratory work will be: complete blood count (CBC); prothrombin time and concentration (PT&PC); partial thromboplastin time (PTT); bleeding time (BT); clotting time (CT); liver function tests and kidney function tests.
Before arrival to the operation room (OR), women will be premedicated by metoclopramide 10mg and ranitidine 50 mg intravenous. Intra operatively, hemodynamics will be recorded baseline before spinal anaesthesia , after its performance, every 3 minutes until delivery and then every 10 minutes till the end of the CS. Any change within 20% of baseline will be accepted and any changes more than 20% will be managed according to guidelines. All groups will be anaesthetized to preform CS with conventional spinal anaesthesia. The TAP block group will receive a landmark orientated Ultrasound guided bilateral TAP block.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care