Postoperative analgesic effect of hydromorphone in patients undergoing single-port video-assisted thoracoscopic surgery: a randomized controlled trial

Figures & data

Table 1 Inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
Willing participants and signed informed consent Age ≤70 years and age ≥18 ASA I–III Selective operation with single port VATS (unilateral pulmonary wedge resection, segmentectomy, lobectomy, or pneumonectomy)	History of mental illness, or chronic pain, or alcohol drug abuse, or long-term use of analgesics, sedative drugs, antidepressant drugs, antianxiety drugs, NSAIDs drugs
	Remarkably abnormal liver and/or kidney function (more than two times of the normal index)
	History of abnormal anesthesia progress. Sedatives, analgesics, antiemetic drugs and anti-pruritic drugs used within 24 h prior to the operation
	Allergy to related opioid drugs
	Monoamine oxidase inhibitors, antidepressants, or antiepileptic drugs administered within 15 days prior to surgery
	Communication disorder
	Women during pregnancy or lactation Unsuitable for clinical study for other reasons

Table 2 PCIA protocol for groups

Analgesic	Group Mb	Group Hb + i	Group Hb
	Morphine	Hydromorphone	Hydromorphone
Background infusion	0	0.002 mg*kg^−1h^−1	0
Bolus	0.015 mg*kg^−1	0.002 mg*kg^−1	0.002 mg*kg^−1
Lockout interval	8 min	10 min	8 min

Figure 1 Study flow diagram.

Table 3 Distribution of sociodemographic characteristics between groups

Variables	Group			P-value
	Group Mb (n=53)	Group Hb + i (n=51)	Group Hb (n=53)
Age (y) (mean ± SD)	58.28±8.28	58.08±7.89	58.11±8.30	0.99
Sex				1.00
Female	27 (50.9%)	26 (51.0%)	27 (50.9%)
Male	26 (49.1%)	25 (49.0%)	26 (49.1%)
Weight (mean ± SD)	61.15±10.28	61.94±8.97	61.08±11.85	0.90
BMI (mean ± SD)	22.59±3.03	23.02±2.64	22.67±3.00	0.73
History of cigarette smoking				0.22
Yes	10 (18.9%)	17 (33.3%)	12 (22.6%)
No	43 (81.1%)	34 (66.7%)	41 (77.4%)
History of alcohol consumption				0.45
Yes	10 (18.9%)	10 (19.6%)	15 (28.3%)
No	43 (81.1%)	41 (80.4%)	38 (71.7%)
Educational level				0.50
Low	22 (41.5%)	19 (37.3%)	22 (41.5%)
Medium	19 (35.8%)	26 (51.0%)	22 (41.5%)
High	12 (22.6%)	6 (11.8%)	9 (17.0%)
Work type				0.40
Manual labor	21 (39.6%)	24 (47.1%)	18 (34.0%)
Knowledge work	32 (60.4%)	27 (52.9%)	35 (66.0%)
Sleep quality				0.66
Poor	6 (11.3%)	11 (21.6%)	7 (13.2%)
Fair	20 (37.7%)	18 (35.3%)	21 (39.6%)
Good	27 (50.9%)	22 (43.1%)	25 (47.2%)

Note: P<0.05 indicated a significant difference.

Table 4 Distribution of clinical characteristics between groups

Variables	Group			P-value
	Group Mb (n=53)	Group Hb + i (n=51)	Group Hb (n=53)
Surgery time (median [IQR])	90 (62.5–105)	80 (65–95)	85 (60–115)	0.63
Anesthesia time (median [IQR])	115 (92.5–135)	100 (85–15)	115 (82.5–140)	0.53
Surgery type				0.77
Wedge resection	12 (22.6%)	8 (15.7%)	8 (15.1%)
Segmentectomy	8 (15.1%)	6 (11.8%)	6 (11.3%)
Lobectomy	33 (62.3%)	37 (72.5%)	38 (71.7%)
Pneumonectomy	0	0	1 (1.9%)
Lymph node dissection				0.11
Yes	41 (77.4%)	47 (92.2%)	46 (86.8%)
No	12 (22.6%)	4 (7.8%)	7 (13.2%)
Adhesion loosening				0.86
Yes	26 (49.1%)	25 (49.0%)	29 (54.7%)
No	27 (50.9%)	26 (51.0%)	24 (45.3%)
Pathologic diagnosis				0.29
Malignant	45 (84.9%)	48 (94.1%)	49 (92.5%)
Benign	8 (15.1%)	3 (5.9%)	4 (7.5%)
VAS at rest (0.5 h after extubation)	0 (0–23.5)	0 (0–17.0)	0 (0–20.0)	0.98

Note: P<0.05 indicated a significant difference.

Table 5 Postoperative patient pain between groups

Variables	Group			P-value
	Group Mb (n=53)	Group Hb + i (n=51)	Group Hb (n=53)	Group effect	Time effect	Interaction effect
VAS at rest				<0.001	<0.001	0.140
8 a.m. 1st day postsurgery	26.0±15.6	17.1±12.1^*#	29.5±16.1
8 p.m. 1st day postsurgery	15.2±12.5	7.7±9.3^*#	19.0±14.4
8 a.m. 2nd day postsurgery	7.7±9.3	3.9±7.0^*#	10.3±10.5
VAS on cough				<0.001	<0.001	0.854
8 a.m. 1st day postsurgery	52.2±14.9	42.8±15.2^*#	55.1±15.0
8 p.m. 1st day postsurgery	42.3±13.7	33.8±10.9^*#	45.5±14.0
8 a.m. 2nd day postsurgery	36.0±13.9	25.4±10.3^*#	36.5±14.1

Notes: *P<0.05 in comparison with Group Mb; ^#P<0.05 in comparison with Group Hb. P<0.05 indicated a significant difference.

Table 6 Analgesic use between groups

Variables	Group			P-value
	Group Mb (n=53)	Group Hb + i (n=51)	Group Hb (n=53)
Bolus frequency
8 a.m. 1st day postsurgery	2 (1–4)	1 (0–3)	3 (1–4)	0.044
8 p.m. 1st day postsurgery	3 (2–5)	1 (0–3)*	3 (1–4.75)	0.008
8 a.m. 2nd day postsurgery	1 (0–3)	0 (0–2)*	1 (0–2.5)	0.036
Analgesic rescue
8 a.m. 1st day postsurgery				0.37
Yes	18 (34.0%)	11 (21.6%)	14 (26.4%)
No	35 (66.0%)	40 (78.4%)	39 (73.6%)
8 p.m. 1st day postsurgery				0.59
Yes	22 (42.3%)	26 (51.0%)	27 (51.9%)
No	30 (57.7%)	25 (49.0%)	25 (48.1%)
8 a.m. 2nd day postsurgery				0.09
Yes	10 (19.2%)	11 (21.6%)	19 (36.5%)
No	42 (80.8%)	40 (78.4%)	33 (63.5%)

Notes: *P<0.05 in comparison with Group Mb. P<0.05 indicated a significant difference.

Table 7 Adverse reaction and sleep quality between groups

Variables	Group			P-value
	Group Mb (n=53)	Group Hb + i (n=51)	Group Hb (n=53)
Nausea
8 a.m. 1st day postsurgery				0.20
Yes	18 (34.0%)	22 (43.1%)	14 (26.4%)
No	35 (66.0%)	29 (56.9%)	39 (73.6%)
8 p.m. 1st day postsurgery				0.74
Yes	10 (19.2%)	9 (17.6%)	7 (13.5%)
No	42 (80.8%)	42 (82.4%)	45 (86.5%)
8 a.m. 2nd day postsurgery				0.64
Yes	3 (5.8%)	4 (7.8%)	2 (3.8%)
No	49 (94.2%)	47 (92.2%)	50 (96.2%)
Vomiting
8 a.m. 1st day postsurgery				0.16
Yes	7 (13.2%)	14 (27.5%)	9 (17.0%)
No	46 (86.8%)	37 (72.5%)	44 (83.0%)
8 p.m. 1st day postsurgery				1.00
Yes	4 (7.7%)	4 (7.8%)	4 (7.7%)
No	48 (92.3%)	47 (92.2%)	48 (92.3%)
8 a.m. 2nd day postsurgery				0.13
Yes	1 (1.9%)	3 (5.9%)	0
No	51 (98.1%)	48 (94.1%)	52
Antiemetic rescue
8 a.m. 1st day postsurgery				0.72
Yes	4 (7.5%)	4 (7.8%)	2 (3.8%)
No	49 (92.5%)	47 (92.2%)	51 (96.2%)
8 p.m. 1st day postsurgery				0.20
Yes	7 (13.5%)	9 (17.6%)	3 (5.8%)
No	45 (86.5%)	42 (82.4%)	49 (94.2%)
8 a.m. 2nd day postsurgery				0.51
Yes	3 (5.8%)	6 (11.8%)	4 (7.7%)
No	49 (94.2%)	45 (88.2%)	48 (92.3%)
Sleep quality during 1st night				0.002
Poor	24 (45.3%)	12 (23.5%)^#	30 (56.6%)
Fair	24 (45.3%)	23 (45.1%)	17 (32.1%)
Good	5 (9.4%)	16 (31.4%)^*#	6 (11.3%)
Sleep quality during 2nd night				0.278
Poor	7 (13.5%)	3 (5.9%)	6 (11.5%)
Fair	20 (38.5%)	14 (27.5%)	21 (40.4%)
Good	25 (48.1%)	34 (66.7%)	25 (48.1%)

Notes: *P<0.05 in comparison with Group Mb; ^#P<0.05 in comparison with Group Hb. P<0.05 indicated a significant difference.

Table 8 Rehabilitation index between groups

Variables	Group			P-value
	Group Mb (n=53)	Group Hb + i (n=51)	Group Hb (n=53)
Cacation within 2 days				0.37
Yes	14 (26.4%)	11 (21.6%)	18 (34.0%)
No	39 (73.6%)	40 (78.4%)	35 (66.0%)
Out-of-bed activity				1.00
First day	50 (94.3%)	48 (94.1%)	50 (94.3%)
Second day	3 (5.7%)	3 (5.9%)	3 (5.7%)
Chest tube extubation time
First tube	1 (1–2)	2 (1–2)	2 (1–2)	0.90
Second tube	3 (2–5)	3 (2–4)	3 (2–4)	0.85
Patient satisfaction				0.006
Bad	5 (9.4%)	4 (7.8%)	9 (17.0%)
Fair	36 (67.9%)	21 (41.2%)*	34 (64.2%)
Good	11 (20.8%)	25 (49.0%)^*#	10 (18.9%)
Excellent	1 (1.9%)	1 (2.0%)	0
Hospital day after surgery	3 (2–5)	3 (2–4)	3 (3–4)	0.79

Notes: *P<0.05 in comparison with Group Mb; ^#P<0.05 in comparison with Group Hb. P<0.05 indicated a significant difference.