Clinical evaluation of XaraColl^®, a bupivacaine-collagen implant, for postoperative analgesia in two multicenter, randomized, double-blind, placebo-controlled pilot studies

Figures & data

Figure 1 CONSORT flow diagram for study 1 and study 2.

Note: ITT consists of all randomized patients who had at least two visual analog scale pain intensity scores.
Abbreviation: ITT, intent-to-treat population.

Table 1 Patient demographics

	Study 1 Treatment group			Study 2 Treatment group
	XaraColl (n = 24)	Placebo (n = 29)	Combined (n = 53)	XaraColl (n = 25)	Placebo (n = 25)	Combined (n = 50)
Age (years)
Mean	46.1	52.6	49.6	47.8	41.7	44.7
Median	44.0	55.0	52.0	51.0	41.0	47.0
Minimum–maximum	24–65	25–88	24–88	24–65	21–82	21–82
Race, n (%)
Asian	0 (0.0)	1 (3.4)	1 (1.9)	0 (0.0)	0 (0.0)	0 (0.0)
Black or African-American	1 (4.2)	1 (3.4)	2 (3.8)	0 (0.0)	2 (8.0)	2 (4.0)
Native Hawaiian or other	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (4.0)	1 (2.0)
Pacific islander
White	23 (95.8)	27 (93.1)	50 (94.3)	25 (100)	22 (88.0)	47 (94.0)
Ethnicity, n (%)
Hispanic or Latino	3 (12.5)	3 (10.3)	6 (11.3)	4 (16.0)	4 (16.0)	8 (16.0)
Not Hispanic or Latino	21 (87.5)	26 (89.7)	47 (88.7)	21 (84.0)	21 (84.0)	42 (84.0)
Weight (kg)
Mean	86.6	85.6	86.1	78.8	80.5	79.7
Median	84.2	83.6	83.9	79.4	79.8	79.4
Minimum–maximum	70.1–108.2	61.4–118.2	61.4–118.2	63.0–94.8	61.2–109.4	61.2–109.4
Height (cm)
Mean	180	177	178	176	177	177
Median	178	178	178	175	179	177
Minimum–maximum	160–196	160–193	160–196	161–193	154–193	154–193
Body mass index (kg/m^2)
Mean	26.8	27.1	27.0	25.5	25.7	25.6
Median	26.0	26.4	26.4	24.8	25.4	25.4
Minimum–maximum	22.0–32.8	20.5–37.2	20.5–37.2	21.0–34.1	20.2–37.0	20.2–37.0

Figure 2 SPI for study 1, study 2, and pooled dataset through 24, 48, and 72 hours.

Note: *Statistically significant (P ≤ 0.05).
Abbreviation: SPI, summed pain intensity.

Figure 3 TOpA for study 1, study 2, and pooled dataset through 24, 48, and 72 hours.

Note: *Statistically significant (P ≤ 0.05).
Abbreviation: TOpA, total opioid analgesia.

Figure 4 I-SPI-TOpA through 24, 48, and 72 hours, study 1, study 2, and pooled dataset.

Note: *Statistically significant (P ≤ 0.05).
Abbreviations: I-SPI-TOpA, integrated SPI and TOpA variable; SPI, summed pain intensity; TOpA, total use of opioid analgesia.

Table 2 Results for SPI, TOpA, and I-SPI-TOpA through 24, 48, and 72 hours for study 1, study 2, and pooled dataset

Time period by dataset	Mean SPI/mm • hour (standard deviation)			Mean TOpA/mg IV morphine eq. (standard deviation)			I-SPI-TOpA
	Treatment	Control	P value	Treatment	Control	P value	P value
24 hours post time 0
Study 1	670 (401)	1191 (602)	<0.001*	18.5a (12.6)	24.6 (15.3)	0.123a	0.013*
Study 2	996 (504)	1270 (567)	0.080	20.6 (19.9)	36.9 (17.6)	0.004*	0.005*
Pooledb	833	1231	<0.001*	19.5	30.8	0.001*	<0.0001*
48 hours post time 0
Study 1	1351 (857)	2130 (1228)	0.012*	30.6a (19.9)	36.5 (25.5)	0.359a	0.097
Study 2	2018 (1093)	2457 (1157)	0.178	36.3 (34.7)	56.4 (32.8)	0.042*	0.039*
Pooledb	1684	2293	0.006*	33.4	46.5	0.024*	0.008*
72 hours post time 0
Study 1	1864 (1239)	2838 (1807)	0.030*	37.2a (29.3)	44.9 (35.0)	0.396a	0.136
Study 2	2842 (1722)	3485 (1807)	0.184	48.7 (46.1)	70.8 (44.3)	0.0940.078
Pooledb	2337	3161	0.014*	42.9	57.8	0.058	0.021*

Notes:

a Includes patient in the treatment group that reported taking morphine rescue medication as maximally allowed and not according to need for pain relief;

b for the pooled data, least squared means are reported and are based on the analysis of variance model that included fixed effects for treatment, study/dose, and treatment-by-study interaction;

* statistically significant (P ≤ 0.05).

Abbreviations: IV, intravenous; eq, equivalents; SPI, summed pain intensity; TOpA, total opioid analgesia; I-SPI-TOpA, integrated endpoint of summed pain intensity and total opioid analgesia.