Liposome bupivacaine for improvement in economic outcomes and opioid burden in GI surgery: IMPROVE Study pooled analysis

Figures & data

Table 1 Summary of individual IMPROVE Study results

	Open colectomy (single center)			Laparoscopic colectomy (6 single-center studies)			Ileostomy reversal (single center)			Ileostomy reversal (multicenter)
	IV opioid PCA regimen (n=18)	Liposome bupivacaine-based multimodal regimen (n=21)	P-value	IV opioid PCA regimen (n=56)	Liposome bupivacaine-based multimodal regimen (n=26)	P-value	IV opioid PCA regimen (n=20)	Liposome bupivacaine-based multimodal regimen (n=23)	P-value	IV opioid PCA regimen (n=11)	Liposome bupivacaine-based multimodal regimen (n=16)	P-value
Mean total amount of postsurgical opioids used (mg)	115	57	0.025	96	32	<0.0001	68	38	0.004	112	20	0.0095
Mean total cost of hospitalization (US$)	11,850	8,766	0.027	13,018	11,234	0.2612	6,790	6,611	0.8	9,282	6,482	0.01
Median LOS (days)	4.9	2.0	0.004	4.0	3.0	0.0019	3.8	3.0	0.854	5.1	3.0	0.0008

Note: Data from Cohen,¹⁶ Vogel,¹⁷ Marcet et al,¹⁸ and Candiotti et al.¹⁹

Abbreviations: IMPROVE, Extended PaIn Relief Trial Utilizing the Infiltration of a Long-Acting Multivesicular LiPosome FoRmulation Of BupiVacaine, EXPAREL; IV, intravenous; LOS, length of stay; PCA, patient-controlled analgesia.

Table 2 Demographics and baseline characteristics (safety population)

Variable	IV opioid PCA regimen (n=122)	Liposome bupivacaine–based multimodal regimen (n=101)
Age, mean (SD), years	56 (16)	53 (15)
Sex, n (%)
Male	66 (54)	49 (49)
Female	56 (46)	52 (52)
Race, n (%)
White	94 (77)	81 (80)
Black	18 (15)	15 (15)
Asian	2 (2)	2 (2)
Other	8 (7)	3 (3)
Body mass index, mean (SD), kg/m^2	27.5 (6.1)	26.7 (5.6)
ASA physical status classification, n (%)
1	5 (4)	2 (2)
2	67 (55)	61 (60)
3	47 (39)	38 (38)
4	3 (3)	0

Abbreviations: ASA, American Society of Anesthesiologists; IV, intravenous; PCA, patient-controlled analgesia; SD, standard deviation.

Figure 1 Mean per-patient postsurgical opioid consumption; amounts are expressed in morphine mg equivalents.

Notes: Error bars represent SD; P<0.0001 for the between-group comparison.
Abbreviations: IV, intravenous; PCA, patient-controlled analgesia; SD, standard deviation.

Figure 2 Median postsurgical LOS in days.

Notes: Error bars represent 95% CIs for the median; P<0.0001 for the between-group comparison.
Abbreviations: CIs, confidence intervals; IV, intravenous; LOS, length of stay; PCA, patient-controlled analgesia.

Figure 3 Geometric mean per-patient total cost of hospitalization (US$).

Note: P=0.0109 for the between-group comparison.
Abbreviations: IV, intravenous; PCA, patient-controlled analgesia.

Table 3 Summary of opioid-related adverse events (efficacy population)

	IV opioid PCA regimen (n=105)	Liposome bupivacaine–based multimodal regimen (n=86)
Patients with any opioid-related adverse event, n (%)	28 (27)	8 (9)a
Nausea	20 (19)	4 (5)b
Vomiting	6 (6)	2 (2)
Urinary retention	5 (5)	1 (1)
Pruritus	5 (5)	0
Postoperative ileus	3 (3)	0
Constipation	0	1 (1)
Somnolence	1 (1)	0

Notes:

a P=0.0027 for the between-group comparison;

b P=0.0036 for the between-group comparison.

Abbreviations: IV, intravenous; PCA, patient-controlled analgesia.

Table 4 Results for other secondary efficacy outcome measures (efficacy population)

	IV opioid PCA regimen (n=105)	Liposome bupivacaine–based multimodal regimen (n=86)
Median (range) time to first opioid use, hours	0.6 (0–70)	1.2 (0.2–120)a
Proportion (%) of patients who reported being extremely satisfied with their postsurgical pain treatment	47	59
Proportion (%) of patients who required hospital readmission after surgery	7	6
Proportion (%) of patients who made unplanned visits with a health care provider after surgery	12	12
Proportion (%) of patients who made contact with a health care provider to discuss recovery after surgery	14	9
Proportion (%) of patients who experienced health problems or changes in health after surgery	15	8

Note:

a P<0.0001 for the between-group comparison.

Abbreviations: IV, intravenous; PCA, patient-controlled analgesia.

Table 5 Summary of adverse events reported in equal to or greater than 3% of patients in either study group (safety population)

Adverse events	IV opioid PCA regimen (n=122)	Liposome bupivacaine–based multimodal regimen (n=101)
Patients with any adverse event, n (%)	75 (62)	42 (42)
Nausea	27 (22)	6 (6)
Diarrhea	7 (6)	7 (7)
Abdominal pain	8 (7)	5 (5)
Abdominal distension	8 (7)	2 (2)
Vomiting	7 (6)	3 (3)
Headache	8 (7)	0
Urinary retention	6 (5)	2 (2)
Anemia	4 (3)	2 (2)
Hypokalemia	1 (<1)	4 (4)
Pruritus	5 (4)	0
Back pain	4 (3)	0
Leukocytosis	4 (3)	0
Urinary tract infection	4 (3)	0

Abbreviations: IV, intravenous; PCA, patient-controlled analgesia.

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