Twenty-four-hour postoperative orphenadrine and ketorolac infusion efficiently precedes orphenadrine-diclofenac infusion as an opioid-sparing analgesic modality after mastectomy

Figures & data

Figure 1. Study flow chart.

Table 1. Demographic and clinical data of the enrolled patients of the studied groups.

Data			Group I (Placebo)	Group II (O/D)	Group III (O/KT)	P-value
Age (years)	Average (±SD)		56±8.6	55±6.7	56±7.4	0.781
BMI (kg/m^2)	Strata	<25	1 (2.3%)	1 (2.3%)	0	0.504
		25–30	24 (55.8%)	17 (39.5%)	21 (78.8%)
		>30–35	18 (41.9)	25 (58.2%)	22 (51.2%)
	Average (±SD)		29.7±2.3	3.2±1.9	3.4±2.1	.283
Menopause	Pre-menopause		6 (14%)	4 (9.3%)	3 (7%)	0.549
	Post-menopause		37 (86%)	39 (9.7%)	40 (93%)
Smoking	Smoker		2 (4.7%)	3 (7%)	1 (2.3%)	0.817
	Ex-smoker		3 (7%)	4 (9.3%)	5 (11.6%)
	Un-smoker		38 (88.3%)	36 (83.7%)	37 (86.1%)
Presence of other morbidities	Yes		4 (9.3%)	3 (7%)	5 (11.6%)	0.759
	No		39 (9.7%)	40 (93%)	38 (88.4%)
ASA grade	I		36 (83.7%)	33 (76.7%)	34 (79%)	0.714
	II		7 (16.3%)	10 (23.3%)	9 (21%)
Hemodynamic variate	Heart rate (beats/min)		8.3±2.7	81±4.8	81.3±3.5	0.414
	Mean arterial pressure (mmHg)		88±4.3	88.7±4	87.6±4.6	.510

BMI: Body mass index; P-value indicates the significance of the inter-group difference as judged by the one-way ANOVA test with Tukey HSD; P value at a cutoff point of ≥0.05 indicates the non-significant difference.

Table 2. Operative data of the enrolled patients of the studied groups.

Data			Group I (Placebo)	Group II (O/D)	Group III (O/KT)	P-value
Operative time (min)	Average (±SD)		120±12.4	122 ±12.6	124 ±12.8	0.343
Anesthesia time (min)	Average (±SD)		131±14.2	134±13.7	135±14.3	0.393
Intraoperative hemodynamics	Heart rate (beats/min)	T0	8.3±2.7	81±4.8	81.3±3.5	0.414
		T1	86±2.5*	86.7±4*	85±3.4*	.515
		T2	77±2.4*	77.6±3.9*	78±3*	.342
		T3	82.3±2*	82.9±3.5*	83.2±3.1*	.373
	Mean arterial pressure (mmHg)	T0	88±4.3	88.7±4	87.6±4.6	0.510
		T1	93.5±4.3*	94.1±3.6	93.4±4.5*	.679
		T2	79.8±5*	78.4±4.7	77.2±6.9*	.104
		T3	9.2±4.5*	9.1±4.1	89.5±4*	.709
Intraoperative blood loss (ml)			245.9±36.3	254±60	250±8.6	.830

T0: Preoperative, T1: at induction of anesthesia; T2: 1-h intraoperative; T3: at time of extubation; *: indicated significant difference versus T0 measures as determined by the paired t-test for two dependent means; P-value indicates the significance of the inter-group difference as judged by the one-way ANOVA test with Tukey HSD; P value at a cutoff point of ≥0.05 indicates the non-significant difference

Figure 2. Patients’ distribution according to the received doses of PO opioids.

Table 3. PO pain data of patients of the studied groups.

Data		Group I (Placebo)	Group II (D/O)	Group III (KT/O)	P-value
Number of requests for rescue analgesia	No (OSR)	0	22 (51.2%)	31 (72.1%)	P1<0.001 P2<0.001 P3=0.017
	Once	7 (16.3%)	5 (11.6%)	8 (18.6%)
	Two	23 (53.5%)	12 (27.9%)	4 (9.3%)
	Three	13 (3.2%)	4 (9.3%)	0
	Average (±SD)	2.14±.7	1.95±.67	1.42±.51	.0047
Average of the total dose of opioid consumedby patients who requested it (mg)		1.7±3.38	9.76±3.35	7.08±2.57	P1=0.301P2=0.0012P3=.023 P2=0.0012 P3=0.023
Duration till 1^st request of rescue analgesia (h)	2-h	8 (18.6%)	3 (7%)	0	P1=0.211 P2=0.0001 P3=0.036
	4-h	14 (32.6%)	6 (14%)	0
	6-h	7 (16.3%)	4 (9.3%)	1 (2.3%)
	8-h	8 (18.6%)	4 (9.3%)	3 (7%)
	12-h	5 (11.6%)	0	0
	16-h	1 (2.3%)	2 (4.7%)	1 (2.3%)
	20-h	0	2 (4.7%)	4 (9.3%)
	24-h	0	0	3 (7%)
	Average (±SD)	5.9±3.4	8±5.6	16.5±8.3	P1=0.068P2<0.001P3=.0006 P2<0.001 P3=0.0006
Pain Numerical Rating scale score	0	1.33±1.15	.4±.88	0	<0.001
	2-h	2.14±1.45	.95±1.34	.14±.5	<.001
	4-h	2.26±1.53	1.2±1.57	.35±.8	<.001
	6-h	2.37±1.13	1.26±1.36	.7±1.1	<.001
	8-h	2.81±1.03	1.58±1.28	1.12±1.2	<.001
	12-h	2.7±1.2	1.95±1.05	1.28±.88	<.001
	16-h	2.35±1.46	2.3±.9	2.05±.87	.402
	20-h	2.37±1.46	2.5±1	2.56±.88	.735
	24-h	1.81±1.28	2.5±1.18	2.63±.85	.002
	Average (±SD)	2.26±.55	1.65±.7	1.2±.5	P1<0.001P2<0.001P3=.0011 P2<0.001 P3=0.0011

P1 indicates the significance of the difference between groups I & II; P2 indicates the significance of the difference between groups I & III; P3 indicates the significance between groups II and III; the significance of the difference in numerical data was estimated using the one-way ANOVA test with Tukey HSD; the significance between numbers and percentages was evaluated using Chi-square test; P value at a cutoff point of <0.05 indicates the significant difference.

Table 4. PO side effects and satisfaction scores by the use of PO infusions.

Data			Group I (Placebo)	Group II (D/O)	Group III (KT/O)	P-value
Ramsey Sedation score	Immediate PO	2	31 (72.1%)	28 (65.1%)	33 (76.7%)	0.487
		3	12 (27.9%)	15 (34.9%)	10 (23.3%)
	30-min PO	1	6 (14%)	2 (4.6%)	0	0.079
		2	29 (67.4%)	31 (72.1%)	36 (83.7%)
		3	8 (18.6%)	10 (23.3%)	7 (16.3%)
	60-min PO	1	10 (23.3%)	6 (14%)	3 (7%)	0.305
		2	28 (65.1%)	30 (69.7%)	34 (79%)
		3	5 (11.6%)	7 (16.3%)	6 (14%)
	8-h PO	2	17 (39.5%)	29 (67.4%)	23 (53.5%)	0.031
		3	19 (44.2%)	13 (3.3%)	18 (41.9%)
		4	7 (16.3%)	1 (2.3%)	2 (4.6%)
	16-h PO	2	9 (2.9%)	22 (51.1%)	16 (37.2%)	0.022
		3	23 (53.5%)	18 (41.9%)	22 (51.2%)
		4	11 (25.6%)	3 (7%)	5 (11.6%)
	24-h PO	2	8 (18.6%)	23 (53.5%)	25 (58.2%)	0.0004
		3	29 (67.4%)	20 (46.5%)	16 (37.2%)
		4	6 (14%)	0	2 (4.6%)
Postoperative nausea & vomiting	Nausea score	1	20 (46.5%)	32 (74.5%)	39 (90.7%)	0.0002
		2	13 (3.2%)	9 (2.9%)	4 (9.3%)
		3	6 (14%)	2 (4.6%)	0
		4	4 (9.3%)	0	0
	Vomiting score	0	30 (69.8%)	37 (86%)	41 (95.4%)	0.016
		1	11 (25.6%)	6 (14%)	2 (4.6%)
		2	2 (4.6%)	0	0
		3	0	0	0
Need for antiemetic injection		Yes	8 (18.6%)	2 (4.6%)	0	0.0036
		No	35 (81.4%)	41 (95.4%)	43 (100%)
24-h amount of wound drainage (ml)			195±54.4	215±82.7	234±88.2	.065
Satisfaction’ scorings (Average ±SD)	Patient’s satisfaction score		70±13	78±12.9	90±7.2	P1=0.005 P2<0.001 P3<0.001
	Surgeons’ satisfaction score		76±1.6	83±1.6	88±6.7	P1=0.003P2<0.001P3=.010 P2<0.001 P3=0.010

P1 indicates the significance of the difference between groups I & II; P2 indicates the significance of the difference between groups I & III; P3 indicates the significance between groups II and III; the significance of the difference in numerical data was estimated using the one-way ANOVA test with Tukey HSD; the significance between numbers and percentages was evaluated using Chi-square test; P value at a cutoff point of <0.05 indicates significant difference