Postoperative pain management with transdermal fentanyl after forefoot surgery: a randomized, placebo-controlled study

Abstract

Background: Quality of life is decreased in patients with hallux valgus deformity, mainly because of pain. Significant improvement is usually achieved by surgery. However, postoperative pain can be moderate to severe for 2-3 days. The aim of the present study was to evaluate the use of transdermal fentanyl for postoperative pain management after forefoot surgery.

Methods: Sixty patients undergoing hallux valgus or hallux rigidus surgery were allocated to receive a patch delivering either fentanyl 12 μg/hour or placebo for postoperative pain. The consumption of rescue opioid oxycodone, the primary outcome measure, was evaluated daily until the fourth postoperative day. Total consumption of oxycodone during the study period was also assessed. Pain scores and possible adverse effects were evaluated every 6 hours during the first 24 hours and on the fourth postoperative day.

Results: The use of rescue opioid was low in both groups, the median (range) consumption of oxycodone being 10 (0-50) mg on the day of surgery (no difference between the groups, P=0.31) and 0 (0-35) mg thereafter. The total combined consumption was 10 (0-105) mg in the fentanyl group and 20 (0-70) mg in the placebo group (P=0.23). There were no statistically significant differences in pain scores or adverse effects between the groups.

Conclusion: As a part of multimodal analgesia with ibuprofen and acetaminophen, a patch delivering fentanyl 12 μg/hour did not significantly decrease the consumption of rescue opioid or pain scores after forefoot surgery.

Keywords: forefoot surgery; hallux rigidus; hallux valgus; multimodal analgesia; pain management; transdermal fentanyl.

Figure 1

Patient enrollment. Abbreviations: h, hours; 4.POD, fourth postoperative day.

Figure 2

Box plot of NRS pain scores in the fentanyl and placebo groups over time. Notes: The top and bottom of the boxes indicate the upper and lower quartiles, and the horizontal line in the box shows the median. Whiskers from the box indicate the most extreme value less than or equal to1.5 interquartile ranges. Outliers (individual values more than 1.5 interquartile ranges) are shown with dots. Abbreviations: NRS, numerical rating scale; Preop, preoperative; Postop, postoperative; 1.POD, first postoperative day; 4.POD, fourth postoperative day; Group F, transdermal fentanyl; Group P, placebo; h, hours.

Figure 3

Box plot of (A) respiratory rate (per minute) and (B) somnolence in the fentanyl and placebo groups over time. Notes: The top and bottom of the boxes indicate the upper and lower quartiles, and the horizontal line in the box shows the median. Whiskers from the box indicate the most extreme point less than or equal to 1.5 interquartile ranges. Outliers (individual values more than 1.5 interquartile ranges) are shown with dots. Abbreviations: NRS, numerical rating scale; Preop, preoperative; Postop, postoperative; 1.POD, first postoperative day; 4.POD, fourth postoperative day; Group F, transdermal fentanyl; Group P, placebo; h, hours.