A feasibility study to investigate the use of a bupivacaine-collagen implant (XaraColl) for postoperative analgesia following laparoscopic surgery

Figures & data

Figure 1 XaraColl (Innocoll Technologies, Athlone, Ireland).

Table 1 Pain intensity over time

Hours post-time 0	Visual analog scale score (mm)*
	Mean	SD	Median	Range
1 hour	48.1	19.0	48	17–80
2 hours	45.6	23.3	42	11–87
4 hours	34.0	25.6	29	4–94
6 hours	31.2	21.7	29	0–83
8 hours	26.9	18.5	27	0–59
10 hours	36.7	14.2	40.5	10–63
12 hours	40.7	13.3	40	24–71
24 hours	28.6	14.8	28	6–59
48 hours	20.2	11.3	18	7–43
72 hours	14.4	14.5	9	0–48

Note: *Pain intensity assessed using a 0–100 mm visual analog scale after aggravated movement (defined as cough).

Abbreviation: SD, standard deviation.

Table 2 Results for SPI and TOpA through 24, 48, and 72 hours

Time period	Mean SPI (mm•hour)			Mean TOpA (mg IV morphine eq)
	Mean	SD	Range	Mean	SD	Range
24 hours post-time 0	805	261	354–1233	19.3	15.4	2.0–58.0
48 hours post-time 0	1390	503	519–2242	24.6	21.8	2.0–80.5
72 hours post-time 0	1749	764	615–3124	26.6	23.2	2.0–85.5

Abbreviations: IV, intravenous; eq, equivalents; SPI, summed pain intensity; TOpA, total use of opioid analgesia.

Table 3 All reported adverse events

Adverse events (mapped to MedDRA system organ class)	Incidence n (%)
All adverse events	8 (80)
Gastrointestinal disorders	4 (40)
Nausea	2 (20)
Constipation	1 (10)
Diarrhea	1 (10)
Vomiting	1 (10)
General disorders and administration-site conditions	1 (10)
Postoperative tremors	1 (10)
Effusion at hernia site	1 (10)
Nervous system disorders	3 (30)
Headache	2 (20)
Paresthesia	1 (10)
Psychiatric disorders	1 (10)
Anxiety	1 (10)
Reproductive system and breast disorders	1 (10)
Scrotal swelling	1 (10)
Respiratory, thoracic, and mediastinal disorders	3 (30)
Sleep apnea	1 (10)
Hypoxemia	2 (20)
Oropharyngeal pain	1 (20)
Skin and subcutaneous tissue disorders	2 (20)
Itching	2 (20)

Abbreviation: MedDRA, Medical Dictionary for Regulatory Activities.