A total of 102 patients who met the inclusion criteria and signed the informed consent for participation in the study from November 2018 to November 2019 were recruited. Finally, 86 patients (44 patients in the TEA/PCIA group,42 patients in the TEA group) were included in the final statistical analysis, details of dropout reasons are given in Fig. 2. Baseline characteristics of the two groups are presented in Table 1(at the end of the manuscript). There was no significant difference in demographic characteristics, comorbidities, surgical type, and incision type between the two groups (P > 0.05). No significant differences were seen between the two groups in terms of operation time, intraoperative fluid intake, intraoperative blood loss, intraoperative sufentanil consumption, cumulative opioid consumption, as well as length of stay and complications in the post anaesthesia care unit (Table 2, at the end of the manuscript).
Table 1
Baseline characteristics of the included patients in the final statistical analysis.
|
TEA/PCIA Group
|
TEA Group
|
P
|
Age (y)
|
56.1±11.1
|
54.6±13.0
|
0.569
|
Sex (Male: Female)
|
36:8
|
33:7
|
0.705
|
BMI (kg m-2)
|
21.7±2.8
|
22.2±3.0
|
0.491
|
ASA I-II, n (%)
|
44
|
42
|
0.924
|
ASA I, n (%)
|
7 (16)
|
7 (17)
|
—
|
ASA II, n (%)
|
37 (84)
|
35 (83)
|
—
|
Comorbidities, n (%)
|
13 (29.5)
|
13 (31.0)
|
0.887
|
Diabetes, n (%)
|
7
|
4
|
—
|
Hypertension, n (%)
|
4
|
8
|
—
|
Respiratory, n (%)
|
2
|
4
|
—
|
Surgical type, n (%)
|
44
|
42
|
0.833
|
Liver surgery, n (%)
|
21 (47)
|
21 (50)
|
—
|
Pancreaticoduodenectomy, n (%)
|
10 (23)
|
12 (28)
|
—
|
Gastrointestinal surgery, n (%)
|
7(16)
|
5(12)
|
—
|
Colorectal surgery, n (%)
|
6 (14)
|
4 (10)
|
—
|
Incision type, n (%)
|
44
|
42
|
0.657
|
Reversed L-shaped incision, n (%)
|
1 (2.3)
|
1 (2.4)
|
—
|
Roof incision, n (%)
|
19 (43.2)
|
20 (47.6)
|
—
|
Subcostal incision, n (%)
|
2 (4.5)
|
2 (4.8)
|
—
|
Midline incision, n (%)
|
15 (34.1)
|
17 (40.4)
|
—
|
Para-midline incision, n (%)
|
7 (15.9)
|
2 (4.8)
|
—
|
Data are expressed as Mean ± SD, number (%). TEA, thoracic epidural analgesia; PCIA, patient-controlled intravenous analgesia; BMI, body mass index; ASA, American Society of Anaesthesiologists.
Table 2
Operative characteristics, PACU variables and cumulative opioid consumption.
|
TEA/PCIA Group
|
TEA Group
|
P
|
Operation time (min)
|
267 [211 to 334]
|
247 [195 to 348]
|
0.694
|
Intraoperative sufentanil consumption (ug)
|
28.5 ± 6.2
|
29.1 ± 8.4
|
0.716
|
Intraoperative fluid intake (mL)
|
3250
[2700 to 3700]
|
3250
[2475 to 5025]
|
0.955
|
Intraoperative blood loss (mL)
|
300 [112.5 to 475]
|
225 [100 to5 25]
|
0.705
|
Blood transfusion, n (%)
|
12 (27.3)
|
12 (28.6)
|
0.893
|
PACU length of stay (min)
|
97.9 ± 40.4
|
104.0 ± 34.8
|
0.513
|
PACU complications, n (%)
|
6 (13.6)
|
8 (19)
|
0.952
|
Pain, n (%)
|
2 (4.5)
|
2 (4.8)
|
—
|
Dysphoria, n (%)
|
1 (2.3)
|
1 (2.4)
|
—
|
Shiver, n (%)
|
3 (6.8)
|
3 (7.1)
|
—
|
Hypertension, n (%)
|
0 (0)
|
1 (2.4)
|
—
|
Pain and dysphoria, n (%)
|
0 (0)
|
1 (2.4)
|
—
|
Cumulative opioid
Consumption (mg)
|
41.48
[26.34 to 66.85]
|
38.64
[29.19 to 42.00]
|
0.109
|
Data are expressed as Mean ± SD, median [IQR], number (%). TEA, thoracic epidural analgesia; PCIA, patient-controlled intravenous analgesia; PACU, post anaesthesia care unit.
The mean VAS pain scores during postoperative days 0–3 in TEA/PCIA group were lower both at rest (1.18 ± 0.46 vs 1.35 ± 0.50; P > 0.05) and on movement (2.45 ± 0.55 vs 2.68 ± 0.52; P < 0.05) as compared with TEA group (Table 3). The analgesic effects were excellent in both groups. TEA/PCIA group had lower VAS pain scores at rest and on movement at each time point as compared with TEA group, with a significant difference at 48 h postoperatively (P < 0.05).
Table 3
Mean VAS pain scores and VAS pain scores at various time points postoperatively.
|
TEA/PCIA Group
|
TEA Group
|
P
|
Mean R-VAS
|
1.18 ± 0.46
|
1.35 ± 0.50
|
0.093
|
Mean M-VAS
|
2.45 ± 0.55
|
2.68 ± 0.52
|
0.046
|
6-h R-VAS
|
1.64 ± 0.75
|
1.88 ± 0.80
|
0.15
|
6-h M-VAS
|
2.95 ± 0.86
|
3.12 ± 0.83
|
0.37
|
24-h R-VAS
|
1.36 ± 0.49
|
1.38 ± 0.70
|
0.89
|
24-h M-VAS
|
2.61 ± 0.62
|
2.79 ± 0.68
|
0.22
|
48-h R-VAS
|
0.95 ± 0.57
|
1.21 ± 0.52
|
0.03
|
48-h M-VAS
|
2.23 ± 0.64
|
2.64 ± 0.66
|
0.004
|
72-h R-VAS
|
0.75 ± 0.62
|
0.93 ± 0.75
|
0.23
|
72-h M-VAS
|
1.98 ± 0.59
|
2.19 ± 0.77
|
0.153
|
Data are expressed as Mean ± SD. TEA, thoracic epidural analgesia; PCIA, patient-controlled intravenous analgesia; VAS, visual analogue scale; R-VAS, VAS score at rest; M-VAS, VAS score on movement. |
No significant difference was found in the postoperative length of hospital stay, the time to urinary catheter removal, and the time of oral intake recovery between the two groups (Table 4). But TEA/PCIA group presented earlier mobilization and recovery of bowel function (shorter time to first pass flatus) (P < 0.05) (Table 4).
There was no significant difference in the incidence of opioid-related adverse events between the two groups (Table 5). Respiratory depression, local anaesthetic systemic toxicity, motor block, and catheter-related problems (dislodge, leakage, or blocking) were not found.
Table 4
Early postoperative recovery variables for the included patients.
|
TEA/PCIA Group
|
TEA Group
|
P
|
Time to first mobilization (d)
|
2 [2 to 3]
|
3 [2 to 4]
|
0.015
|
Time to first pass flatus (d)
|
2 [2 to 3]
|
3 [2 to 3]
|
0.048
|
Time of oral intake recovery (d)
|
4 [2 to 5]
|
3 [2 to 6]
|
0.513
|
Time of urinary catheter removal (d)
|
3 [2 to 4.75]
|
3 [2 to 4]
|
0.832
|
PLOS(d)
|
9 [7 to 11.75]
|
9.5 [8 to 13]
|
0.345
|
Data are expressed as median [IQR]. TEA, epidural analgesia; PCIA, patient-controlled intravenous analgesia; PLOS, postoperative length of hospital stays. |
Table 5
Incidences of inadequate analgesia and opioid-related adverse events.
|
TEA/PCIA Group
|
TEA Group
|
P
|
Inadequate analgesia
|
9 (20.5)
|
13 (31.0)
|
0.265
|
Nausea/vomiting, n (%)
|
9 (20.5)
|
8 (19.0)
|
0.269
|
Mild
|
3 (7.0)
|
3 (7.1)
|
0.269
|
Moderate
|
5 (11.4)
|
5 (11.9)
|
0.269
|
Severe
|
1 (2.1)
|
0 (0.0)
|
0.269
|
Hypotension, n (%)
|
11 (25.0)
|
8 (19.0)
|
0.506
|
Dizziness, n (%)
|
3 (6.8)
|
4 (9.5)
|
0.646
|
Pruritus, n (%)
|
0 (0.0)
|
2 (4.8)
|
0.143
|
Urinary retention, n (%)
|
1 (2.3)
|
2 (4.8)
|
0.529
|
Others*, n (%)
|
0 (0.0)
|
0 (0.0)
|
—
|
Data are expressed as number (%). TEA, thoracic epidural analgesia; PCIA, patient-controlled intravenous analgesia; *: No respiratory depression, local anaesthetic intoxication, motor block, catheter prolapse were observed during the study. Patients with mean arterial pressure less than 65 mmHg were diagnosed with hypotension. |
There was no significant difference between the two groups in the overall cost of hospitalization and the cost of anaesthesia (Table 6).
Table 6
Overall cost and cost of anaesthesia*.
|
TEA/PCIA Group
|
TEA Group
|
P
|
Total cost
(RMB)
|
75 011
[53 172 to 93 036]
|
75 773
[55 569 to 102 799]
|
0.777
|
Cost of anaesthesia
(RMB)
|
5226
[4933 to 5740]
|
5171
[4658 to 5872]
|
0.412
|
Data are expressed as median [IQR]. *: A total of 82 patients were included in the statistical analysis, and four patients were excluded due to the special billing payment method in our hospital (three in TEA/PCIA group and one in TEA group). TEA, thoracic epidural analgesia; PCIA, patient-controlled intravenous analgesia. |