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

Caputo 2011.

Methods Parallel RCT
Ethics committee: approved by the Central and South Bristol Research Ethics Committee (registration number E5471)
Informed consents: written informed consents were obtained
Site: Yale School of Medicine, New Haven, CT, USA; and University of Bristol, Bristol, UK; and Clinica Montevergine, Mercogliano, Italy
Setting: university hospital
Dates of data collection: August 2003 to November 2007
Funding: funded by the British Heart Foundation
Registration: unspecified
Participants 226 participants; mean age 65.7 years; sex distribution: 22 females and 204 males
Inclusion criteria
  1. Adult (≥ 16 years) participants

  2. Undergoing non‐emergent off‐pump CABG


Exclusion criteria
  1. Intravenous heparin, warfarin, or clopidogrel at the time of surgery

  2. Suffered from bleeding diathesis

Interventions Intervention
  1. Epidural analgesia (N = 109)


Comparator
  1. Systemic analgesia (N = 117)


Premedication: benzodiazepines
Induction: fentanyl, propofol, and pancuronium or vecuronium
Maintenance: isoflurane or propofol
Surgery: off‐pump CABG
Outcomes Relevant to this review
  1. Risk of mortality

  2. Risk of myocardial infarction

  3. Risk of pulmonary complications

  4. Risk of atrial fibrillation or atrial flutter

  5. Risk of neurological complications

  6. Pain scores

  7. Haemodynamic variables


Others
  1. Length of hospital stay

Notes Correspondence: information received from study authors
Conflict of interest: none declared
DOI: 10.1093/icvts/ivt001
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomized treatment allocations were generated using Stata version 8. Participants were stratified by the consultant team via 1:1 allocation using blocks of varying sizes
Allocation concealment (selection bias) Low risk Allocation details were concealed in sequentially numbered, opaque sealed envelopes. These were prepared by the clinical trials and evaluation unit
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "open"
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "open"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All randomized participants were included in the analysis
No participants withdrew from the trial
Selective reporting (reporting bias) Low risk All results were reported
Other bias Unclear risk Intention‐to‐treat
Epidural anaesthesia: 18 not performed and 9 failed epidural
Systemic analgesia: 3 participants received epidural analgesia
Groups had similar demographic characteristics, except that lung disease/chronic obstructive airways disease was more common in the epidural group (23% vs 12%)