A Dose-Response Relationship Study of Prophylactic Nalbuphine to Reduce Pain During the Awakening Period in Patients Undergoing Laparoscopic Total Hysterectomy: A Randomized, Controlled, Double-Blind Clinical Study

Figures & data

Table 1 Demographic Data of Patients and Intraoperative General Conditions

	Group C (n = 20)	Group P1 (n = 20)	Group P2 (n = 20)	Group P3 (n = 20)	Group P4 (n = 20)	Group P5 (n = 20)	P
Age (years)	50.50 (48.75, 53.50)	48.50 (46.75, 51.50)	51.00 (47.75, 51.25)	49.50 (47.75, 52.00)	48.50 (47.00, 50.50)	50.00 (47.00, 52.50)	0.288
Height (cm)	159.85 ± 5.22	158.90 ± 4.56	159.75 ± 4.64	160.55 ± 4.10	157.40 ± 3.59	159.85 ± 3.44	0.262
Weight (kg)	61.25 ± 6.97	59.65 ± 6.86	60.17 ± 5.89	59.17 ± 5.57	61.58 ± 6.71	60.77 ± 5.06	0.813
ASA Grade (I/II)	15/5	16/4	15/5	17/3	17/3	14/6	0.875
Non-menopausal (%)	50	70	45	60	75	55	0.352
Anesthesia time (min)	121.50 (107.75, 128.50)	122.00 (103.00, 131.00)	122.00 (115.50, 125.00)	117.50 (102.50, 130.25)	120.50 (115.00, 132.00)	117.00 (108.00, 125.75)	0.842
Operation time (min)	95.00 (83.25, 109.75)	97.50 (82.00, 107.25)	100.50 (94.50, 108.00)	101.50 (86.75, 108.00)	102.00 (97.25, 110.00)	100.00 (84.75, 108.50)	0.796
Remifentanil (mg)	2.28 ± 0.54^a	1.63 ± 0.41	1.92 ± 0.28	1.88 ± 0.52	2.10 ± 0.43^a	2.02 ± 0.52	0.001
1% Propofol (mL)	44.49 ± 11.70	38.17 ± 5.66	42.67 ± 10.40	41.48 ± 7.77	42.76 ± 8.32	40.08 ± 10.35	0.330
Prophylactic analgesic effect (%)	0	90*	80*	55*	35^a	15^ab	< 0.001

Notes: NRS score ≤ 3 indicates that there is no pain in the recovery period and is classified as effective analgesia; NRS pain score ≥ 4 indicates postoperative acute pain; Patients with NRS score ≥ 4 were moderate and severe pain; Data are presented as a number or mean ± SD or median (IQR). Statistical significance was defined as P < 0.05; *P < 0.05 versus group C; ^aP < 0.05 versus group P1; ^bP < 0.05 versus group P2.

Abbreviations: ASA, American Society of Anesthesiologists; NRS, numeric rating scale; SD, standard; IQR, interquartile range.

Figure 1 Flow diagram of the study.

Table 2 NRS Scores at Different Time Points Within 24 Hours After the Operation

	Group C (n=20)	Group P1 (n=20)	Group P2 (n=20)	Group P3 (n=20)	Group P4 (n=20)	Group P5 (n=20)	Wald χ^2	P
30 min after extraction	5.00 (4.00, 6.00)^abe	2.00 (1.00, 3.00)	2.50 (2.00, 3.00)	3.00 (2.75, 4.50)	4.00 (3.00, 6.00)^a	5.00 (4.00, 5.00)^abe	73.877	< 0.001
1 h post-operative	5.00 (4.00, 5.00)^e	3.00 (2.00, 5.00)^c	3.50 (3.00, 4.00)	4.00 (3.00, 5.00)	5.00 (4.00, 6.00)^abe	4.00 (3.00, 5.00)^e	22.842	< 0.001
4 h post-operative	4.00 (4.00, 6.00)^e	3.00 (3.00, 5.00)^cd	3.50 (3.00, 4.00)	4.00 (3.00, 5.00)	4.50 (3.00, 5.25)^e	4.50 (3.00, 5.00)^e	10.788	0.056
8 h post-operative	4.00 (3.00, 5.00)	3.00 (3.00, 5.00)^c	4.00 (3.00, 5.00)	4.00 (3.00, 4.00)	3.50 (3.00, 5.00)	4.00 (3.00, 5.00)^e	2.330	0.802
24 h post-operative	3.00 (2.00, 3.25)	2.00 (2.00, 4.00)	3.00 (2.00, 3.25)	3.00 (2.00, 4.00)^d	3.00 (2.00, 4.00)	3.00 (2.00, 3.00)	3.663	0.599
Wald χ^2	42.127	54.466	10.332	35.911	35.596	45.245
P	< 0.001	< 0.001	0.035	< 0.001	< 0.001	< 0.001
Overall comparisons
Group (Wald χ^2, P)	23.984, < 0.001
Time (Wald χ^2, P)	97.083, < 0.001
Interaction between group and time (Wald χ^2, P)	73.630, < 0.001

Notes: Data are presented as median (IQR); ^aP < 0.05 versus group P1; ^bP < 0.05 versus group P2; ^cP < 0.05 versus 30 min after extraction; ^dP < 0.05 versus 1 h post-operative; ^eP < 0.05 versus 24 h post-operative.

Abbreviations: NRS, numeric rating scale; IQR, interquartile range.

Table 3 Comparison of Cough Score During Extubation and Sedation Score 10 Minutes After Extubation

	Group C (n=20)	Group P1 (n=20)	Group P2 (n=20)	Group P3 (n=20)	Group P4 (n=20)	Group P5 (n=20)	P
Minogue Score	2.00 (1.00, 3.00)	1.00 (1.00, 1.00)*	1.00 (1.00, 2.00)	1.00 (1.00, 2.00)	1.00 (1.00, 2.00)	1.50 (1.00, 2.00)	0.018
Ramsay Score	2.00 (1.00, 2.00)	2.00 (1.00, 2.25)	2.00 (1.00, 2.25)	2.00 (1.00, 2.00)	2.00 (1.00, 3.00)	2.00 (1.00, 2.25)	0.961

Notes: Data are presented as median (IQR); *P < 0.05 versus group C.

Abbreviation: IQR, interquartile range.

Table 4 Comparison of the Number of Postoperative Salvage Analgesia

	Group C (n=20)	Group P1 (n=20)	Group P2 (n=20)	Group P3 (n=20)	Group P4 (n=20)	Group P5 (n=20)	P
Total number (n)	5	1	1	2	3	2	—
Flurbiprofen axetil	5	1	1	2	3	2	—
Nalbuphine	0	0	0	0	0	0	—
Fentanyl	0	0	0	0	0	0	—
Incidence of salvage analgesia (%)	25	5	5	10	15	10	0.498

Table 5 Comparison of the Incidence of Adverse Reactions After Surgery

	Group C (n=20)	Group P1 (n=20)	Group P2 (n=20)	Group P3 (n=20)	Group P4 (n=20)	Group P5 (n=20)	P
Total number (n)	4	6	3	4	2	4	—
Dizziness	0	1	0	0	0	1	—
Drowsiness	0	1	0	0	0	0	—
Chills	0	0	0	1	0	0	—
Hypotension	0	0	0	0	0	0	—
Respiratory depression	0	0	0	0	0	0	—
PONV	4	4	3	3	2	3	0.955
Incidence of adverse reactions (%)	20	30	15	20	10	20	0.762

Abbreviation: PONV, postoperative nausea and vomiting.