Author, date and country | Patient group | Study type (level of evidence) | Outcomes | Key results | Study Weaknesses |
---|---|---|---|---|---|
Zink et al, 2011 USA | 58 patients presenting to the hospital’s trauma system, emergency room, or clinics with rib fractures receiving lignocaine patches (29) identified through pharmacy records, or matched control subjects not recieving lidocaine patches (29). | Observational study. Prospective cohort of patients were retrospectively analysed for use of lignocaine patches. They were matched to control subjects treated without patches. | Primary end point: change in subjective pain scores in first 24 hours after patch placement. Relevant secondary end points: change in opiate use in first 24 hours. | Primary: In the 24 hours after patch placement, lignocaine patch (LP) patients had a greater decrease in pain scores (LP 1.2 vs controls 0.0, p=0.01). Secondary: No significant change in opiate use (LP -8.4mg vs controls 0.5mg change in morphine dose, p=0.25). | Observational study, partly retrospective with unblinded and subjective primary outcome assessment. Potential confounders: 1) Large difference in pain scores and opiate use between the 2 groups before patch placement therefore not truly matched controls. 2) Injury severity scores were high in both groups (21) suggesting the presence of other significant injuries. Low numbers in subgroup analysis with isolated chest injury (9 lignocaine patch vs 8 controls) therefore no significant difference found in primary outcome. 3) In lignocaine patch group a greater proportion of patients had more fractures, flail chest, chest drain placement and epidurals (although not significant due to overall low study numbers). 4) Epidurals – some treated with lignocaine patches after epidurals whilst some had both treatments synchronously Potential bias: 1) Unblinded outcome assessment 2) Assessment of pain scores - subjective scores used in patients who were aware they had patches applied |
Ingalls et al 2010 USA | 58 patients with rib fractures admitted to a Level 1 trauma centre receiving either lignocaine patch 5% (33) or placebo patch (25) | Randomized, double-blind, placebo-controlled trial | Primary – total (IV and oral) opiate use. Relevant secondary outcomes – non-opiate pain medication and average visual analogue pain score | Primary: No significant difference in total IV opiate used; median 0.23 units (IQR 0.07-1.02) in lignocaine group vs median 0.26 units (IQR 0.08-0.59) in placebo group (p=0.56). No significant difference in total oral opiate use; median 4 units (IQR 2-10) in lignocaine group vs 7 units (IQR 2.5-14) in placebo group (p=0.11). Secondary: Mean pain scores (+/-SEM) 5.6+/- 0.4 in lignocaine group vs. 6.0+/- 0.3 in placebo group (p=0.39). | Study powered to detect a reduction of 33% in pain scores which is quite ambitious. Study too small and underpowered to show statistically significant difference between the 2 groups. But, there was a trend towards improved pain scores in the lignocaine patch group. Pain scores were collected by nursing staff over 72hours and averaged to a single pain score for the study period. Patients were only followed up for 72 hours. Theses were all trauma patients with other injuries. However, the other injuries were not listed. Patients were given an Injury severity score (17.3 in lignocaine group and 17.9 in placebo group) which may suggest significant other/distracting injury. Conflict of interest: study sponsored by the drug company |