A randomized, multicenter, pilot study comparing the efficacy and safety of a bupivacaine-collagen implant (XaraColl^®) with the ON-Q PainBuster^® Post-op Pain Relief System following open gynecological surgery

Figures & data

Figure 1 ON-Q Pain Buster^® Post-op Pain Relief System (I-Flow Corporation, Lake Forest, CA).

Note: Scale in inches.

Figure 2 XaraColl^® (Innocoll Technologies, Athlone, Ireland).

Figure 3 CONSORT flow diagram.

Note: The ITT population consists of all randomized patients who underwent surgery and who received a study treatment.
Abbreviations: ITT, intent-to-treat; ON-Q, ON-Q Pain Buster^® Post-op Pain Relief System.

Table 1 Patient demographics

	Treatment group
	XaraColl^® (n = 14)	ON-Q (n = 13)	Combined (n = 27)
Age (years)
Mean (SD)	43.3 (11.5)	43.4 (6.2)	43.3 (9.2)
Median (minimum, maximum)	39.0 (28, 63)	41.0 (36, 59)	41.0 (28, 63)
Race, n (%)
Asian	1 (7.1)	0 (0.0)	1 (3.7)
Black or African American	2 (14.3)	5 (38.5)	7 (25.9)
White or Caucasian	11 (78.6)	8 (61.5)	19 (70.4)
Ethnicity, n (%)
Hispanic or Latino	3 (21.4)	0 (0.0)	3 (11.1)
Not Hispanic or Latino	11 (78.6)	13 (100.0)	24 (88.9)
Weight (kg)
Mean (SD)	71.7 (12.8)	73.3 (11.0)	72.5 (11.8)
Median (minimum, maximum)	77.0 (53.6, 90.5)	74.1 (56.4, 93.6)	76.6 (53.6, 93.6)
Height (cm)
Mean (SD)	162.1 (6.4)	160.2 (8.6)	161.2 (7.5)
Median (minimum, maximum)	161.3 (150.0, 171.0)	162.6 (139.7, 175.0)	162.6 (139.7, 175.0)
Body mass index (kg/m^2)
Mean (SD)	27.1 (3.8)	28.7 (4.6)	27.9 (4.2)
Median (minimum, maximum)	27.6 (21.4, 32.5)	29.0 (22.9, 37.0)	28.1 (21.4, 37.0)
Surgical procedure performed
Abdominal hysterectomy	10 (71.4)	11 (84.6)	21 (77.8)
Myomectomy	3 (21.4)	1 (7.7)	4 (14.8)
Abdominal hysterectomy with right salpingo-oophorectomy	1 (7.1)	0 (0.0)	1 (3.7)
Right salpingo-oophorectomy (adnexal only)	0 (0.0)	1 (7.7)	1 (3.7)

Abbreviations: ON-Q, ON-Q PainBuster^® Post-op Pain Relief System; SD, standard deviation.

Table 2 Total use of opioid rescue analgesia (mg intravenous morphine equivalent)

	Treatment group		Non-inferiority and superiority statistics
	XaraColl^®	ON-Q
Total opioid use from 0 to 24 hours
Mean (SD)	46.9 (21.6)	67.0 (32.4)
Mean difference			−20.2
Upper bound of one-sided 95% CI of the mean difference			−2.20
P-value*			0.067
Total opioid use from 0 to 48 hours
Mean (SD)	55.4 (22.8)	74.9 (35.4)
Mean difference			−19.4
Upper bound of one-sided 95% CI of the mean difference			−0.01
P-value*			0.100
Total opioid use from 0 to 72 hours
Mean (SD)	62.0 (25.3)	85.4 (41.9)
Mean difference			−23.4
Upper bound of one-sided 95% CI of the mean difference			−0.84
P-value*			0.089
Total opioid use from 0 to 96 hours
Mean (SD)	67.9 (28.2)	90.8 (46.1)
Mean difference			−22.9
Upper bound of one-sided 95% CI of the mean difference			2.01
P-value*			0.129

Note:

* P-value is from a two-sided test on the difference between treatment groups (test for superiority if XaraColl was better than ON-Q) using an analysis of variance model with treatment as the effect.

Abbreviations: CI, confidence interval; SD, standard deviation; ON-Q, ON-Q PainBuster^® Post-op Pain Relief System.

Table 3 Responses to patient questions

Question	XaraColl^® (n = 14) n (%)	ON-Q (n = 13) n (%)	P-value
Evaluation of pain control
4. Excellent	9 (64.3)	8 (61.5)	0.847a
3. Very good	1 (7.1)	2 (15.4)
2. Good	2 (14.3)	2 (15.4)
1. Fair	1 (7.1)	1 (7.7)
0. Poor	0 (0.0)	0 (0.0)
Missing	1 (7.1)	0 (0.0)
Satisfaction with study treatment (not pain control)
5. Very satisfied	9 (64.3)	7 (53.9)	0.176a
4. Satisfied	3 (21.4)	3 (23.1)
3. Somewhat satisfied	1 (7.1)	1 (7.7)
2. Dissatisfied	0 (0.0)	0 (0.0)
1. Very dissatisfied	0 (0.0)	2 (15.4)
Missing	1 (7.1)	0 (0.0)
Any problems or difficulties with study treatment?
No	12 (85.7)	10 (76.9)	0.593b
Yes	1 (7.1)	3 (23.1)
Missing	1 (7.1)	0 (0.0)
Reported problems
“Felt dizzy, my cut burns”	1 (7.1)	0 (0.0)
“Place of catheter drained constantly causing gown, clothing and bedding to be soaked. Also, experienced numbness down left leg up to 24 hours after removal”	0 (0.0)	1 (7.7)
“Soreness of tongue not sure if related to study”	0 (0.0)	1 (7.7)
“Understanding how to fill out the assessments while being so ill”	0 (0.0)	1 (7.7)

Notes:

a P-value from Cochran–Mantel–Haenszel test;

b P-value from Fisher’s exact test.

Abbreviation: ON-Q, ON-Q PainBuster^® Post-op Pain Relief System.

Table 4 All reported adverse events

	Treatment group
	XaraColl^® (n = 14) n (%)	ON-Q (n = 13) n (%)	Combined (n = 27) n (%)
All adverse events	7 (50.0)	9 (69.2)	16 (59.3)
Blood and lymphatic system disorder	1 (7.1)	0 (0.0)	1 (3.7)
Anemia	1 (7.1)	0 (0.0)	1 (3.7)
Gastrointestinal	4 (28.6)	5 (38.5)	9 (33.3)
Constipation	2 (14.3)	0 (0.0)	2 (7.4)
Flatulence	2 (14.3)	0 (0.0)	2 (7.4)
Nausea	1 (7.1)	2 (15.4)	3 (11.1)
Abdominal distension	0 (0.0)	1 (7.7)	1 (3.7)
Glossodynia	0 (0.0)	1 (7.7)	1 (3.7)
Rectal bleeding	1 (7.1)	0 (0.0)	1 (3.7)
Vomiting	1 (7.1)	1 (7.7)	2 (7.4)
General disorders and administration site conditions	1 (7.1)	3 (23.1)	4 (14.8)
Pyrexia	1 (7.1)	2 (15.4)	3 (11.1)
Peripheral edema	0 (0.0)	1 (7.7)	1 (3.7)
Chills	0 (0.0)	1 (7.7)	1 (3.7)
Injury, poisoning, and procedural complications	1 (7.1)	0 (0.0)	1 (3.7)
Postoperative wound complication (reported as numbness at surgical site)	1 (7.1)	0 (0.0)	1 (3.7)
Metabolism and nutrition disorders	1 (7.1)	0 (0.0)	1 (3.7)
Dehydration	1 (7.1)	0 (0.0)	1 (3.7)
Musculoskeletal and connective tissue disorders	1 (7.1)	1 (7.1)	2 (7.4)
Back pain	0 (0.0)	1 (7.7)	1 (3.7)
Joint swelling	1 (7.1)	0 (0.0)	1 (3.7)
Nervous system disorders	2 (14.3)	2 (15.4)	4 (14.8)
Headache	2 (14.3)	1 (7.7)	3 (11.1)
Hypoesthesia	0 (0.0)	1 (7.7)	1 (3.7)
Renal and urinary disorders	0 (0.0)	1 (7.7)	1 (3.7)
Urinary retention	0 (0.0)	1 (7.7)	1 (3.7)
Skin and subcutaneous tissue disorders	2 (14.3)	0 (0.0)	2 (7.4)
Rash	2 (14.3)	0 (0.0)	2 (7.4)

Notes: Counts indicate the numbers of patients reporting one or more events that map to the MedDRA system organ class. At each level of summarization (system organ class or preferred term) patients were only counted once. Percentages of patients are given in parentheses. Each patient at each system organ class and preferred term level is counted only once.

Abbreviations: MedDRA, Medical Dictionary for Regulatory Activities; ON-Q, ON-Q PainBuster^® Post-op Pain Relief System.