Table 2.
Studies involving use of the 5% medicated plaster to treat post-surgical, post-surgical, post-traumatic, or scar pain
| Authors and study design | No. of patients | Mean baseline pain rating | No. of plasters (daily) |
Treatment duration | Main efficacy outcomes (end of observation) |
|---|---|---|---|---|---|
| Habib et al. [79]. Short-term, prospective, double-blind, placebo-controlled, add-on study, following radical, retropubic prostatectomy | 36 | N/A | 1 (1/2 on each side of the wound) | 1 day | Significant reduction in pain scores from baseline: 19–33% on coughing over 24 h (p < 0.0001 vs. placebo) and 17–32% at rest for up to 6 h (p = 0.0003 vs. placebo) |
| Saber et al. [80]. Randomized, add-on, controlled study, following laparoscopic ventral hernia repair | 15 | N/A | 1 | 3 days | Pain intensity (VRS) at discharge was lower than in control group: 3.13 with plaster vs. 4.80 without plaster (p = 0.0067) |
| Hans et al. [78]. Prospective, observational, non-randomized, add-on study, in patients with chronic PNCCP after surgical and non-surgical trauma | 40 | 7.2 (VAS) | ≤3 | 12 weeks | Reduction in mean pain intensity to 4.6 (reduction of 36.1%; p < 0.001). Pain reduction of ≥ 30% and ≥ 50% in 65% and 47.5% of patients, respectively |
| Correa-Illanes et al. [58]. Prospective, observational, case series in patients with painful scars resulting from burns, skin degloving or orthopedic surgery. 48% add-on | 29 | 6.7 (NRS) | 1/4 or 1/2 | 13.9 weeks | Mean pain intensity decreased to 2.72 (reduction of 58.2%). Mean size of painful area decreased from 23 to 6.5 cm2 (reduction of 72.4%) |
| Nicolaou et al. [83]. Case reports on monotherapy (17%) and add-on therapy (83%) in patients with PNCCP (17 patients also had chronic low back pain) | 58 | N/A | 1/8 to 3 | 0.25–27 months or continuing | ‘Much improvement’ or ‘very much improvement’ judged to have been made by 76% of patients, according to the CGIC |
| Correa-Illanes et al. [59]. Prospective, observational study in trauma patients with LNP of >3 months’ duration | 19 | 6.7 (NRS) | 1/2 plaster in one patient, 1/4 plaster in 18 patients | Mean duration 19.5 weeks | Mean pain intensity decreased to 2.8 (reduction of 58.2%). Mean painful area decreased from 17.8 to 2.1 cm2 (reduction of 87.6%) |
| Bischoff et al. [84]. Randomized, double-blind, placebo-controlled crossover trial | 21 | 6 at rest, 7 during movement, 8 during palpation (NRS) | 1 | 14 days with either lidocaine or placebo plaster/14-day washout period/14 days with alternative plaster | Changes in pain intensity following treatment with lidocaine or placebo (summed pain intensity differences—SPID) were not significantly different |
| Likar et al. [85]. Retrospective analysis, add-on to existing treatment regimens | 7 | 8.6 (Likert scale) | 1/2 to 2 plasters (12 h on) | 6 months | Pain intensity dropped by 6.7 points to 1.9 |
All data are expressed as the mean unless otherwise stated. For studies with a control group, only lidocaine data are shown
CGIC clinical global impression of change, N/A not available, NRS numerical rating scale, PNCCP postoperative/post-traumatic neuropathic chronic cutaneous pain, VAS visual analogue scale