SLR - January 2018 - Jessica Brodie
Pain Relief After Operative Treatment of an Extremity Fracture: A Noninferiority Randomized Controlled Trial
Reference: Helmerhorst, GTT, Zwiers R, Ring D, Kloen P. Pain Relief After Operative Treatment of an Extremity Fracture: A Noninferiority Randomized Controlled Trial. The Journal of Bone and Joint Surgery. 2017 Nov 15;99(22):1908–1915.
Scientific Literature Review
Reviewed By: Jessica Brodie, DPM
Residency Program: NYU Langone Hospital Systems, Brooklyn, NY
Podiatric Relevance: The use of opioids for postoperative pain management has become commonplace in the United States and Canada, whereas worldwide, the use of opioids is significantly less with reported similar pain and satisfaction with pain relief. This study assessed satisfaction with pain management in patients with isolated extremity fractures, which required surgery, with the objective of demonstrating that opioid pain management is unnecessary in these injuries.
Methods: This single blind randomized study utilized 52 patients with equal characteristics. Group 1 consisted of 27 subjects, and Group 2 consisted of 25 subjects. Inclusion criteria included patients 18 or older with isolated extremity fractures. Patients with multiple fractures, stress fractures, pathologic fractures, liver/renal dysfunction, diagnosed constipation, allergies or pregnant/breastfeeding women were excluded. Upon postoperative discharge, Group 1 received oral acetaminophen with a maximum dose of 1,000 mg every six hours. Group 2 received the same dose of acetaminophen with a prescription for 50 mg of tramadol every eight hours as needed. Patients were allowed rescue medication for a maximum of five days. At the time of suture removal, each participant completed three questionnaires; measuring self-efficacy in response to nociception, anxiety in response to nociception and, lastly, mood. Each patient reported rate of pain on an 11-point scale. The study documented injury characteristics, age, sex, work status and education level.
Results: One hundred ninety-eight patients were assessed with 52 meeting the inclusion criteria, which became two groups. Four of the patients, two from each group, did not attend their two-week follow-up and were excluded. Nine patients from Group 2 only used acetaminophen, despite tramadol being available, and were excluded. The end mean satisfaction of pain management was 8.3 for Group 1 and 8.5 for Group 2, determining there to be no significant difference in pain. It was noted that Group 1 medication was not inferior to Group 2 medications on all measures of pain intensity, except for worse pain, which did not exceed a 2.0-point margin. Independent factors associated with higher pain intensity were younger age and lower education. Factors associated with greater mean pain intensity were younger age and lower mood. Group 2 reported significantly more adverse effects, most commonly nausea.
Conclusions: There were no statistically significant differences found between patients with isolated extremity fractures treated with only acetaminophen versus those treated with acetaminophen and tramadol. Both groups reported pain was well controlled overall. In addition to satisfaction with pain relief, there was no significant difference in pain intensity scores in those in Group 2. When comparing independent factors to pain levels, the only significant correlations found were those between lower education and worse pain intensity levels and between lower mood and mean pain intensity. This introduced a psychological component that authors imply may improve with proper education of expectations and breaking the cultural stereotype that opioids are required to properly controlled pain. In conclusion, this paper determined that Step 2 medications (hydromorphone/oxycodone), the current standards in the United States and Canada, may be unnecessary in patients with isolated extremity fractures.