Summary of findings for the main comparison. Epidural analgesia compared with systemic analgesia for cardiac surgery with or without cardiopulmonary bypass in adults.
| Epidural analgesia compared with systemic analgesia for cardiac surgery with or without cardiopulmonary bypass in adults | ||||||
| Patient or population: adults undergoing cardiac surgery with or without cardiopulmonary bypass Settings: trials were conducted in university hospitals (n = 60) or at a tertiary care centre (n = 3). Trials were conducted in Australia (n = 3); Bangladesh (n = 1); Canada (n = 1); China (n = 2); Cuba (n = 1); Czech Republic (n = 2); Denmark (n = 5); Egypt (n = 1); Germany (n = 5); India (n = 6); Italy and UK (n = 1); Japan (n = 2); Korea (n = 1); Lithuania (n = 1); Macedonia (n = 1); Norway (n = 3); Poland (n = 1); Russia (n = 1); Serbia (n = 1); Spain (n = 1); Sweden (n = 3); Taiwan (n = 1); Turkey (n = 8); The Netherlands (n = 4); UK (n = 5); and USA (n = 3) Intervention: epidural analgesia Comparison: systemic analgesia | ||||||
| Outcomes | Illustrative comparative risks (95% CI)* | Risk difference or relative effect (95% CI) | No. of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Systemic analgesia | Epidural analgesia | |||||
| Mortality (0 to 30 days) | Study population | RD 0.00 (‐0.01 to 0.01) | 3418 (38 studies) | ⊕⊕⊝⊝ lowa | ||
| 6 per 1000 | 7 per 1000 (4 to 13) | |||||
|
Myocardial infarction (0 to 30 days) |
Study population | RD ‐0.01 (‐0.02 to 0.00) | 2713 (26 studies) | ⊕⊕⊝⊝ lowa | ||
| 40 per 1000 |
28 per 1000 (21 to 39) |
|||||
|
Pulmonary complications (0 to 30 days) |
Respiratory depression | RD ‐0.03 (‐0.05 to ‐0.01) | 1736 (21 studies) | ⊕⊕⊝⊝ lowb | NNTB 32 (95% CI 22 to 102) |
|
| Study population | ||||||
| 70 per 1000 |
42 per 1000 (30 to 57) |
|||||
| Pneumonia | RD ‐0.03 (‐0.07 to 0.01) | 1107 (10 studies) | ⊕⊕⊕⊝ moderatec | |||
| Study population | ||||||
| 148 per 1000 |
79 per 1000 (59 to 105) |
|||||
|
Atrial fibrillation or atrial flutter (0 to 2 weeks) |
Study population | RD ‐0.06 (‐0.10 to ‐0.01) | 2431 (18 studies) | ⊕⊕⊕⊝ moderatec | NNTB 14 (95% CI 8 to 90) |
|
| 327 per 1000 |
258 per 1000 (234 to 283) |
|||||
|
Risk of neurological complications (0 to 30 days) |
Cerebrovascular accident | RD ‐0.00 (‐0.01 to 0.01) | 2232 (18 studies) | ⊕⊝⊝⊝ very lowd | ||
| Study population | ||||||
| 12 per 1000 |
11 per 1000 (6 to 18) |
|||||
| Epidural haematoma |
RD 0.00 (‐0.01 to 0.01) |
3982 (53 studies) |
⊕⊝⊝⊝ lowa | |||
| Study population | ||||||
| 0 per 1000 |
0 per 1000 (0 to 2) |
|||||
| Duration of tracheal intubation | Mean duration of tracheal intubation was 0.78 SMD lower (‐1.01 to ‐0.55) |
3353 (40 studies) | ⊕⊕⊕⊝ moderatec | The difference was equivalent to 2.4 hourse and was more evident in older trials (see text) | ||
| Pain at rest at 6 to 8 hours after surgery | Mean pain scores were 1.35 SMD lower (‐1.98 to ‐0.72) | 502 (10 studies) |
⊕⊕⊕⊝ moderatef | The difference was equivalent to 1 on a score from 0 to 10e | ||
|
Haemodynamic support (in hospital) |
Hypotension or need for vasopressor boluses |
RD 0.21 (0.09 to 0.33) |
870 (17 studies) |
⊕⊝⊝⊝ lowg | The number needed to harm is 4 (95% CI 3 to 12) | |
| Study population | ||||||
| 451 per 1000 |
284 per 1000 (243 to 330) |
|||||
| Inotropic or vasopressor infusions |
RD 0.00 (‐0.06 to 0.07) |
1821 (23 studies) |
⊕⊝⊝⊝ lowh | |||
| Study population | ||||||
| 344 per 1000 |
338 per 1000 (302 to 376) |
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| *The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Confidence intervals were calculated using VassarStats (http://www.vassarstats.net/). CI: confidence interval; NNTB: number needed to treat for an additional beneficial outcome; RD: risk difference; SMD: standardized mean difference. | ||||||
| GRADE Working Group grades of evidence. High quality: further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: we are very uncertain about the estimate. | ||||||
aDowngraded by one level for risk of bias and by one level for imprecision. bDowngraded by one level for risk of bias and by one level for possibility of publication bias.
cDowngraded by one level for risk of bias.
dDowngraded by one level for risk of bias, by one level for imprecision, and by one level for publication bias.
eThe equivalence was obtained by multiplying the SMD by a typical standard deviation of one of the included trials (Higgins 2011a).
fDowngraded by one level for heterogeneity.
gDowngraded by two levels for risk of bias.