Author, date and country | Patient group | Study type (level of evidence) | Outcomes | Key results | Study Weaknesses |
---|---|---|---|---|---|
Liu et al, 2004, USA | Meta-analysis of 15 trials enrolling 1178 patients over period 1996 to 1st Jan 2004 obtained from searching Medline, American College of Physicians Journal Club, Cochrane database of Systematic reviews, and Database of Abstracts of Reviews of Effects | Meta-analysis (level 1a) | Odds of death | TEA 0.7% vs. GA 0.3% OR 1.56 (0.35–6.91) P=0.56. 1178 pts | Almost all the RCT's were small including 3 studies with <20 participants Pooled numbers still too few to determine effects on myocardial ischaemia and mortality 7 studies reported in the table below not part of the meta-analysis |
Odds of MI | TEA 2.3% vs. GA 3.4% OR 0.74 (0.34–1.59); P=0.44. 1026 pts | ||||
Odds of suffering dysrhythmias (AF or tachycardia) | TEA 17.8% vs. GA 30% OR 0.52 (0.29–0.93) P=0.03. 913 pts | ||||
Odds of pulmonary complications | TEA 17.2% vs. GA 30.3% OR 0.41 (0.27–0.60) P<0.00001. 644 pts | ||||
Odds of time to tracheal extubation (hours) | TEA 6.9 h vs. GA 10.4 h Mean Difference –4.5 (–7 to –2) P=0.0005. 905 pts | ||||
Odds of postoperative pain (Visual analogue scale) | TEA 12.4 mm vs. GA 19.6 mm Mean Difference –7.8 mm; (–15 to –0.6); P=0.03. 392 pts | ||||
Incidence of neurological injury | No cases of spinal/epidural haematoma | ||||
Scott et al, 2001, UK | 420 patients undergoing elective CABG surgery Standard GA with 72hrs narcotic analgesia v standard GA with 96hrs TEA Elective CABG pts with normal preoperative coagulation status Epidurals inserted at T2/3 or T3/4 in OR immediately preoperatively – operation postponed if "bloody tap" obtained Bilateral T1-T10 block instituted with Bupivacaine 0.5% and maintained with Bupivacaine / Clonidine infusion perioperatively +/- additional Bupivacaine top-ups postop. | PRCT (level 1b) | Time to extubation (to achieve standard unit extubation criteria) | 51/206 (25%) TEA vs.11/202 (5.5%) GA extubated within 4 h (P<0.0001) | Avoidance of Beta-blockade during study period unless clinically indicated might be confounding factor in development of dysrhythmias 73/202 (36%) GA v 100/202 (49%) TEA had no preoperative complications p=0.012 |
Incidence of new supraventricular arrhythmias | 21/206 (10.2 %) TEA vs. 45/202 (22.3%) GA P=0.001 | ||||
Incidence of proven respiratory tract infection | 31/206 (15.3%) TEA vs. 59/202 (29.2%) GA group developed LRTIs P=0.0007 | ||||
Maximal inspiratory lung volume (ILV)-subset analysis of 47 TEA & 46 GA pts | Maximal ILV better in TEA vs. GA group – 985± 326 ml vs. 733±208 ml; P<0.0001 | ||||
Overall any complication rate in 1st 5 days postoperatively | 84/206 (40.8%) TEA vs. 108/202 (53.5%) GA P=0.011 | ||||
Neurological sequelae | No permanent neurological complications associated with use of TEA | ||||
Turfey et al, 1997, UK | 218 consecutive patients undergoing CABG surgery 118/218 Standard GA+target-controlled Alfentanil for 1st 24hrs post-op, then IV PCA Morphine for 48hrs 100/218 Standard GA + TEA. TEA instituted with 0.5% Bupivacaine and maintained with a Bupivacaine / Clonidine infusion Epidurals inserted immediately before induction of anaesthesia and run for 5 days postoperatively TEA not used in presence of abnormal coagulation (Aspirin only not a contraindication) | Retrospective Cohort (level 2b) | Time to tracheal extubation | 21% TEA vs. 2% GA extubated within 1 h of surgery (P<0.002) | Not a randomised study Decision to use TEA based on Anaesthetist's preference Study from same unit as that of Scott et al |
Incidence of postoperative arrhythmias | 18/100 (18%) TEA vs. 38/118 (32%) GA (P=0.02) | ||||
Incidence of respiratory complication | 16% TEA vs. 21% GA pts P=NS | ||||
Other complications | No significant differences in incidence of other renal, GI or haematological complication. No significant difference in cardiac complications, difference in IABP use/ no VAD use. No difference in inotrope use | ||||
Incidence of neurolgical complication | 6/100 (6%) TEA vs. 9/118 (7.6%). GA pts had neurological complication– not significant. TEA group CNS complications – one leg weakness (no epidural haematoma on MRI) | ||||
Barrington et al, 2005, Australia | 120 pts undergoing elective CABG surgery Comparison of high thoracic epidural anesthesia / analgesia + general anaesthetic (HTEA) to general anaesthesia only (GA) Pts with abnormal coagulation, recent Aspirin ingestion or evidence of neurological dysfunction excluded from study HTEA group – epidural inserted at T1/2 or T2/3 the day before surgery and established with Ropivacaine / Fentanyl GA group – standard GA with postoperative morphine infusion | PRCT (level 1b) | Time to tracheal extubation | Mean time to extubation 15 min HTEA vs. 430 min GA (P<0.0001) 60% HTEA pts vs. 5% GA pts extubated within 30 min of completion of surgery (P<0.0001) Time to extubation beyond 30 min not significantly different HTEA vs. GA | Significant higher incidence of peripheral vascular & cerebrovasc disease in HTEA v GA group (p=0.016 & 0.002 respectively) Group allocations not masked – might bias towards early extubation |
VAS assessment of postoperative analgesia | HTEA pain scores significantly less than GA scores at all time points with/without coughing | ||||
Cardiac troponin (cTnI) & CK-MB levels preop and 12 and 24 h post-cross-clamp release | cTnI levels HTEA vs. GA – both raised at 12 & 24 h but no significant difference between groups | ||||
12 lead ECGs preop and on postop days 1 & 5 (2 blinded observers) | 3/60 (5%) HTEA vs. 5/60 (8.3%) GA pts developed new ECG changes 1/60 (1.6%) HTEA vs. 2/60 (3.3%) GA pts had evidence of transmural MI on basis of ECG but no difference in incidence of myocardial ischaemia on basis of ECG or biochemical criteria | ||||
Neurological sequelae | No neurological complications related to HTEA | ||||
Priestley et al, 2005, Australia | 100 pts randomised to either standard GA + postop IV Morphine PCA or standard GA + TEA for 48hrs postop, then epidural PCA Meperidine for further 24hrs TEA inserted on night before surgery at T1-T4 and induced with Ropivacaine / Fentanyl. Surgery NOT postponed in presence of "bloody tap" but attempt made to resite elsewhere Exclusions - pre-existing coagulopathy - anticoagulation - potent anti-platelet drugs - systemic / local infection - arthritis of spine with history of associated neurological deficit - cognitive impairment Aspirin & other NSAID's usually discontinued 1 week before surgery but not a contraindication to TEA | PRCT (level 1b) | Time to tracheal extubation | TEA vs GA medians 3.2 vs. 6.7 h (P<0.0001) | Study powered on basis of length of hospital stay Male preponderance in both groups (5-7:1) Decision to discharge made by unblended surgeons Whilst study did not demonstrate earlier discharge in TEA group it did demonstrate earlier discharge of both study TEA & control groups in comparison to non-study pts |
Time to achieve standard mobilisation goal of ability to climb 2 flights of stairs unaided | No significant difference TEA vs GA in time to achieve standard mobilisation goals, criteria for discharge, and actual time to discharge | ||||
Time to achieve standard unit discharge criteria | 24% of total cohort discharged on Day 4 & 33% on Day 5 compared to 2% & 18 of pts outwith study population | ||||
Actual time to discharge | No significant differences | ||||
Respiratory function | No significant differences | ||||
Atrial fibrillation | 10/50 (20%)GA vs. 11/50 (22%) TEA developed AF | ||||
Postoperative pain VAS scores | Analgesia better in TEA group at rest and during coughing but statistically significant during 1st postop 24 h only - 16/50 (32%) GA vs 6/50 (12%) TEA had VAS >40 mm (P=0.015) | ||||
TEA complications | No major complications related to epidural technique 4/50 (8%) epidurals 'failed' 3/50 (6%) TEA vs 2/50 (4%) GA pts developed postop urinary catheterisation | ||||
Royse et al, 2003, Australia | 80 CABG pts randomised to GA+high TEA (HTEA) or GA+PCA Morphine HTEA inserted at T1/2 or T2/3 on night before surgery. Induced & maintained with Ropivacaine / Fentanyl until 3rd postop day | PRCT (level 1b) | Pain on 1st and 2nd postop days assessed by 10cm VAS at rest and with coughing | Significantly better pain scores with HTEA vs GA (mean cm scores): Day 1 Rest 0.02 vs. 0.8 P=0.032. Day 1 Cough 1.2 vs. 4.4 P<0.001 Day 2 Rest 0.1 vs. 1.2 P=0.044 Day 2 Cough 1.5 vs. 3.6 P=0.005 | |
Post operative ventilation/hospital stay | HTEA vs. GA 2.6± 2.5 h vs. 5.4±3.1 h (P<0.001) Length of ITU/hospital stay – no significant difference HTEA vs. GA Postop creatinine/atrial fibrillation – no significant difference HTEA vs. GA | ||||
Assessment of lung function - preop and daily spirometry and SpO2 on air - arterial blood gases on postop day 1 | Lung function lower both groups - – O2 higher in HTEA than GA group; P=0.041 (P=0.041 corrected)1 – PEFR higher in HTEA than GA group on all days incl Day 3 when epidural discontinued P=0.001 (0.003 corrected). 1. P values corrected using technique to test 6 hypotheses | ||||
Nygard et al, 2004, Denmark | 163 pts scheduled for CABG surgery 2x2 factorial study to compare high TEA, Amiodarone therapy or both against control in preventing postop AF Exclusions - recent use of Amiodarone - Amiodarone toxicity - Warfarin therapy or coagulopathy - use of antidysrhythmics (other than Beta blockers, digoxin & calcium-channel blockers) Group E - high TEA Group A - Amiodarone Group E+A - high TEA + Amiodarone Group C - Control Epidural groups - epidural inserted at T1-3 the day before surgery and maintained for 96hrs. Initiated with Bupivacaine & maintained with Bupivacaine / Morphine Amiodarone groups - 1800mg orally, then IV infusion commencing after induction of anaesthesia for 3 days - 900mg/24hrs All patients received standard GA and non-TEA pts IV morphine analgesia 5 days of continuous Holter monitoring - automated & blinded manual reporting | PRCT (level 1b) | Incidence of new onset AF - 5 min | Group E - 22/44 (50%). Group A - 10/36 (27.8%). Group E+A - 10/35 (28.6%). Group C - 20/48 (41.7%). No signif difference in AF incidence between TEA (E & E +A) groups and non-TEA (A & C) groups P=0.538 No significant difference in incidence of AF requiring treatment in TEA E & E+A) vs. non-TEA (A & C) groups - 28/79 (35%; 95% CI 25 - 47%) vs. 25/84 (30% 95% CI 20 - 41%) P=0.66 | |
Jideus et al, 2001, Sweden | 141 patients undergoing elective CABG 45/141 randomly selected for standardised GA with intraoperative & postoperative TEA; 96/141 control group TEA inserted at T2/3, T3/4 or T4/5 the day before surgery and established with Bupivacaine. TEA postoperatively maintained with Bupivacaine / Sufentanil for 96hrs or until onset of sustained AF 96/141 control patients ¡V standardised GA only with postop Ketobemidone analgesia. Both groups monitored with Holters for 24hrs preop & 96hrs postop | PRCT (level 1b) | Incidence of sustained AF >30 s on Holter | 13/41 (31.7%) TEA vs. 29/80 (36.3%) GA (P=0.77) Onset time of AF 1.9 days (TEA) vs. 2.2 days (GA) post-op P=0.23 | Lack of information about randomisation process Control group twice the size of treatment group Exclusions in control group may have affected AF outcomes Beta-blockers more likely to be withdrawn in TEA group ¡V might affect AF outcomes |
Pre and postop levels of Neuropeptide Y (NPY), Chromogranin A (CgA), Chromogranin B (CgB) Pancreatic polypeptide (PP) Epinephrine Norepinephrine | Postop NPY levels significantly lower in TEA vs. GA group(P=0.002 vs. P=0.60). CgA & CgB levels unchanged postop in both groups PP significantly lower in both TEA & GA groups postop (P=0.04 & P=0.0001). Raised Epinephrine in both groups in day 1 though less marked in TEA group (TEA P=0.002 vs. GA P<0.001). Pre & postop Norepinephrine levels unchanged in TEA group (P=0.73) but significant increase in GA group (P=0.002) | ||||
Salvi et al, 2004, Italy | 106 consecutive pts undergoing off-pump surgery under combined TEA & general anaesthesia TEA performed immediately prior to anaesthesia at T1/2 or T2/3 and induced and maintained with Ropivacaine / Sufentanil to block C7/T1 to T6/T7. Catheter removed on 3rd postop day Exclusion criteria - abnormal coag studies - abnormal platelet counts - recent anticoagulation / thrombolysis - coagulation disorders - neuroaxial pathology - recent acute infarct | Retrospective cohort (level 2b) | Time to extubation | Mean time to extubation 4.6± 2.9 h (median 4; range 0.5–12 h) | Uncontrolled cohort group – no comparison group TEA unsuccessful in 2/106 (1.8%) pts Bloody tap in 1/106 (0.9%) pts No dural taps |
Length of ITU stay | Mean ITU stay 1.5± 0.8 days (median 1.0; range 0.5–6 days) | ||||
Incidence of MI | 4/106 (3.8%) pts presented with signs of myocardial ischaemia – attenuated/abolished by institution of TEA | ||||
Incidence of AF | 11/206 (10.6%) developed AF during ITU stay | ||||
Assessment of pain using Visual analogue score | Good analgesia at rest and with coughing | ||||
Neurological complications | 1/106 (0.9%) pts developed postop paraplegia - emergency MRI excluded 2° to spinal/epidural haematoma | ||||
Chakravarthy et al, 2005, India | 2113 adults undergoing cardiac surgery (CABG, valve surgery, congenital surgery) under general + epidural anaesthesia over 13 year period Epidural catheter inserted at C7 to T3 level day evening before surgery in patients with normal coagulation studies and platelet number, no anti-platelet therapy for 1 week and heparin discontinuation for 6-12 hours pre-insertion. Epidural avoided in patients on anti-platelet therapy, with coagulation problems, with previous surgery to cervical or thoracic spine or local infection. Evolving epidural regime over time using combinations of Lidocaine+/-Epinephrine / Bupivacaine / Morphine / Buprenorphine / Fentanyl | Cohort (level 2b) | Dural puncture | 19/2224 (0.85%) – unable to ID epidural space/insert catheter –18/19 – dural puncture –10/18 resited successfully 22/2224 (0.98%) –haemorrhagic tap –12/22 resited successfully 2113 epidurals performed | No outcome parameters Audit designed to look at complications, not outcomes No standard Epidural or GA regime – regime evolved over study period |
Complications | 4/2113 – develpoed temporary neurological deficits (transient monoplegias) of up to 24 h which recovered on withdrawal/removal of epidural catheter No other neurological sequelae | ||||
Sanchez et al, 1998, Denmark | 571 consecutive pts scheduled for CABG over 2 year period Pts not given epidural if on Warfarin; with a prothrombin-proconvertin<50%; or on Aspirin within last 7 days Epidural inserted day before surgery at T1-T3 level. Induced with Bupivacaine & maintained with Bupivacaine / Fentanyl. Standard GA | Cohort (level 2b) | Extubation | Median time to extubation 345 min (range 75–1305 min) | 13/571 (2%) epidurals abandoned - 12 uncertain blocks + one unsuccessful catheter placement 558/571 (98%) epidurals successful 1/558 dural puncture – surgery postponed. After 1 day without complication, epidural resited and surgery proceeded 403/558 (72%) on antiplatelet medication |
ITU stay | Median duration of ITU stay 1 day (range 1–13 days) 445/558 (80%) epidurals left for 4–5 days | ||||
Complications | No documented spinal haematomas causing neurolgoical symptoms. No severe radiating back pains. No unexplained/progressive neurological deficits | ||||
Pastor et al, 2003, Spain | 714 pts undergoing CABG under combined TEA + standard GA over 7yr period TEA inserted between T1-T3 immediately preop & induced and maintained with Bupivacaine or Ropivacaine periop & Ropivacaine / Fentanyl postop. Inclusion criteria - APTT<45 secs - PT (INR) < 1.5 - Platelets > 80,000/ìl - adequate (7 days ) preop suspension of aspirin & clopidigrol Exclusion criteria - pre-existing neurological disorder - failed block - infection at puncture site Technical criteria - max 3 attempts at TEA - midline approach - TEA at least 60 mins before heparinisation - MRI / neurosurgery availability TEA usually terminated at 4 days - normal coagulation - before therapeutic anticoagulation - >12hrs after last but >4hrs before next dose of LMW heparin if used | Prospective cohort (level 2b) | Technical complications of TEA | 6/714 (0.84%) dural punctures, no complaints of pain/ paraesthesia; no 'bloody taps' 6/6 (100%) dural punctures successfully resited elsewhere. No postop complications in this group | Observational study designed to confirm that adherence to standard safety measures adverts risk of epidural haematoma No comparison of TEA group to control group |
Time to extubation (standard unit criteria) | Median time to extubation 0 h (0–168) 496/714 (75.3%) extubated in the OR | ||||
Length of ITU stay | Median length of ITU stay 48 h (22–456 h) | ||||
Length of hospital stay | Median length of hospital stay 8 days (3–121) | ||||
General morbidity and mortality | 26/714 (3.6%) pts required, prolonged IPPV, reintubation or tracheostomy | ||||
Complications of TEA | 3/714 (0.42%) awoke with suspicious motor findings and underwent MRI scanning No evidence of epidural haematoma or sub-acute/chronic space occupying processes | ||||
Ho et al, 2000, Hong Kong | 4583 patients undergoing cardiac surgery utilising TEA in period up to 1999 reported in previously published trials Assessment of risk of epidural haematoma / spinal injury using Hanley & Lippman-Hand mathematical modelling technique | Cohort (level 2b) | Mathematical calculation of statistical risk of epidural haematoma / spinal injury | Risk of spinal injury from epidural haematoma during TEA between 1:150,000 and 1:1,500 (95% confidence) and up to 1:1,000 (99% confidence) | Remains a mathematical estimation |
Berendes et al, 2003, Germany | 73 pts scheduled for CABG surgery randomised to GA only (control) or GA+TEA TEA inserted day before surgery at C7/T1 level & initiated with Bupivacaine 0.5% & Sufentanil and maintained with Bupivacaine Exclusions - abnormal coagulation - renal insufficiency - ventricular dysfunction (EF<50%) - valvular surgery - heart failure | PRCT (level 1b) | Regional LV function by transoesophageal echo (TOE) | 37/73 GA only vs. 36/73 GA+ Postop LV function scores significantly better in TEA vs. GA pts: 0.78 vs. 0.38; P<0.05 | Pts with pre-existing ventricular dysfunction excluded Presentation of TOE, ANP & BNP graphical with little absolute numerical data Although 2 year mortality a 2° outcome study not powered to detect significant difference |
Pre & postop cardiac troponin I | Peak Cardiac Troponin I significantly less in TEA vs. GA pts 1.6 vs. 5.7 ng/ml; P<0.05 | ||||
Pre, intra & postop Atrial & Brain natriuretic peptide | ANP maximally raised during reperfusion after cross-clamping – TEA raised significantly less than GA increase (98 vs. 211 ng/ml; P=0.03) BNP increase 6 h post-ITU admission & peaked 24 h postop – TEA significantly attenuated BNP peak – mean BNP peak TEA vs. GA 108 vs. 189 ng/ml (P=0.01) | ||||
Extubation time | Mean time to extubation 3.4 vs. 9.2 h | ||||
Complications | No complications related to TEA; No other significant complications | ||||
Filinger et al, 2002, Lebanon | 60 pts undergoing cardiac surgery Excluded if any contraindication to TEA (heparin, warfarin, coagulopathy, local/systemic infection) 30/60 GA+TEA Epidural inserted immediately before induction of anaesthesia and induced with morphine/bupivacaine 30/60 GA+postop IVI Morphine | PRCT (level 1b) | Time to tracheal extubation | Time to tracheal extubation GA vs. TEA 9.5 vs. 10.7 h (P=0.49) | Study powered using total hospital costs as proxy for hospital outcome |
Duration of ITU stay | ITU stay GA vs. TEA 30 vs. 31.7 h (P=0.84) Hospital stay GA vs. TEA 160 vs. 156 h (P=0.84) | ||||
Duration of hospital stay | Hospital stay GA vs. TEA 160 vs. 156 h (P=0.84) | ||||
Pain control using 100mm VASs | Pain control on 1st postop day - no significant difference between GA and TEA groups | ||||
Urinary free cortisol | Urinary free cortisol GA vs. TEA 120 vs. 150 µg/dl (P=0.25) | ||||
Total hospital charges | Total charges GA vs. TEA $36,955 vs. $40,026 (P=0.20 | ||||
Cardiopulmonary complication rate | 20/30 (67%) GA vs. 30/30 (100%) TEA group required catecholamines post-CPB (P=0.0005) Incidence of AF 23% in both groups No difference in incidence of ischaemia between groups 9/30 (30%) GA developed 12 'complications'; 12/30 (40%) TEA developed 17 'complications' No neurological sequelae related to TEA |