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. 2019 Mar 1;2019(3):CD006715. doi: 10.1002/14651858.CD006715.pub3

El‐Shora 2018.

Methods Parallel RCT
Ethics committee: approved by the ethics committee
Informed consents: written informed consents obtained
Site: Egypt
Setting: 2 centres from university hospital
Dates of data collection: from March 2016 to March 2017
Funding: departmental/institutional
Registration: PACTR201603001502110 (www.pactr.org).
Participants 145 participants: mean age 43.5 years; sex distribution: 68 females and 77 males
Inclusion criteria
  1. Patients who underwent elective cardiac surgery for valvular or coronary artery disease through full median sternotomy as a primary procedure


Exclusion criteria
  1. Refused to participate in the research

  2. With preoperative coagulopathy

  3. Severe organ insufficiency (e.g. serum creatinine > 3 mg and/or liver dysfunction)

  4. Needed reoperation within 24 hours

Interventions Intervention
  1. Epidural analgesia (N = 75)


Comparator
  1. Bilateral paravertebral (N = 70)


Induction: midazolam, fentanyl, propofol, lidocaine, and pancuronium
Maintenance: isoflurane and pancuronium
Surgery: valve or CABG with CPB
Outcomes Relevant to this review
  1. Risk of mortality

  2. Risk of neurological complications

  3. Pain scores

  4. Tracheal extubation


Others
  1. Urinary retention

  2. Vomiting

  3. Acute kidney injury

  4. Re‐exploration for bleeding

  5. ICU length of stay

  6. Hospital length of stay

Notes Correspondence: email sent 18 November 2018; study authors asked us to extract the information from the trial
Conflict of interest: none
DOI: 10.1055/s‐0038‐1668496
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Blocked stratified randomization was used to assign participants to 2 groups via 1:1 allocation
Randomization sequence was generated randomly online using https://www.randomizer.org/; block size ranged from 4 to 6 participants. Randomization was stratified by participating centres
Allocation concealment (selection bias) Low risk On the day before surgery, participants were sorted to 1 of the 2 groups based on blocked single‐blinded randomization
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Single‐blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Single‐blinded
Cardiac anaesthesia specialist, not participating in data collection or patient follow‐up, performed the block designated for each participant (either bilateral thoracic paravertebral or thoracic epidural block)
A nurse collected the data without pre‐knowledge of participants' assigned groups
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 5 participants were excluded from the paravertebral group: 3 for in‐hospital mortality and 2 for reoperation within 24 hours
One participant in the epidural group died in hospital, but data for this participant were included in the analysis
Selective reporting (reporting bias) Low risk All results were reported
Other bias Low risk Groups well balanced
“intention‐to‐treat” principle