Study 1 Can we eliminate opioids after ACL reconstruction? A prospective randomized controlled trial Background Multimodal pain protocols have been effective for post-surgical pain control; however, no published protocol has been effective in eliminating opioid use. Purpose: To compare a non-opioid multimodal pain protocol versus traditional opioid medication for postoperative pain control in patients undergoing anterior cruciate ligament reconstruction (ACCL). Study design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 90 patients undergoing primary ACLR were evaluated for participation. We conducted a prospective, randomized, controlled trial in accordance with the 2010 CONSORT (Consolidated Standards of Reporting Trials) statement. The study arms were a multimodal non-opioid analgesic protocol (acetaminophen, ketorolac, diazepam, gabapentin, and meloxicam) and a standard opioid regimen (hydrocodone-acetaminophen), and the primary outcome was visual analog scale (VAS) pain scores. postoperative for 10 days. Secondary outcomes included patient-reported outcomes, complications, and satisfaction. Observers were blinded and patients were not blinded to the intervention. Results: A total of 9 patients did not meet the inclusion criteria and 19 patients refused to participate. Therefore, 62 patients were analyzed, with 28 patients randomized to the opioid group and 34 to the non-opioid multimodal group. Patients receiving the non-opioid multimodal analgesic regimen demonstrated significantly lower VAS scores compared to patients receiving opioid analgesics (p < 0.05). Patients were administered the Patient-Reported Outcomes Measurement and Information System Pain Interference Brief Form, and no significant differences were found in the patients’ preoperative scores (opioid group, 58.6 ± 7. 9; non-opioid multimodal group, 57.5 ± 7.4; P = 0.385) and 1-week postoperative scores (opioid group, 66.3 ± 8.2; multimodal non-opioid group, 61.4 ± 8. 8; P = 0.147). When we adjusted for potential confounders (age, sex, body mass index, graft type), no significant differences in pain control were found between the 2 groups. The most common adverse effects for both groups were drowsiness and constipation, with no differences between the groups. All patients in the non-opioid multimodal group reported satisfactory pain management. Conclusions: A non-opioid multimodal pain protocol provided at least equivalent pain control compared to traditional opioid analgesics in patients undergoing ACLR. Minimal side effects were observed, which did not differ between groups, and all patients reported satisfaction with pain management. |
Study 2 Purpose To evaluate the effectiveness of a multimodal non-opioid analgesic protocol in controlling postoperative pain compared to opioids after primary arthroscopic rotator cuff repair. Methods Seventy consecutive patients undergoing primary rotator cuff repair were evaluated for eligibility. An observer-blinded prospective randomized controlled trial was designed according to the Consolidated Standards of Reporting Trials 2010 (CONSORT) statement. The two arms of the study included a multimodal non-opioid pain regimen for the experimental group and standard narcotic treatment for the control group. The primary outcome was visual analog scale (VAS) pain scores during the first 10 postoperative days. Secondary outcomes included the PROMIS-PI (Patient-Reported Outcomes Measurement Information System-Pain Interference) scale, patient satisfaction, and adverse drug events. Results Thirty patients refused to participate or were excluded, and 40 patients were included in the final analysis. A total of 23 patients were in the traditional group and 17 patients were in the non-opioid group. Control patients with opioid pain treatment reported a significantly higher VAS pain score on postoperative day 1 (opioid: 5.7 ± 2, non-opioid: 3.7 ± 2.2; P = 0.011) and the postoperative day 4 (opioids: 4.4 ± 2.7, non-opioids: 2.4 ± 2.2; p = 0.023). No significant differences were observed on any other postoperative day. When mixed measured models were used to control for confounders, the non-opioid group demonstrated significantly lower VAS and PROMIS-PI scores ( P < 0.01) at each time point. Patients in the traditional analgesia group reported significantly more days with constipation (P = 0.003) and days with upset stomach (P = 0.020) than those in the non-opioid group. Conclusion The present study found that a multimodal non-opioid pain protocol provided equivalent or better pain control compared to traditional opioid analgesics in patients undergoing primary arthroscopic rotator cuff repair. Minimal side effects with some improvement were observed in the non-opioid multimodal pain cohort. All patients reported satisfaction with pain management. |
Comments
A non-opioid pain management regimen offered the same pain relief as common prescription opioids, according to two recent studies of common sports surgeries.
Opioids can help people control pain, but they can be addictive. Nationally, opioid prescriptions increased from 76 million in 1990 to a peak of 255 million in 2012. Between 1990 and 2017, opioid-related deaths increased six-fold.
The challenge for surgeons is to minimize opioid use and optimize patients’ pain control after surgery, says Kelechi Okoroha, MD, an orthopedic surgeon and sports medicine specialist at Mayo Clinic. Dr. Okoroha is the lead author of both studies.
Orthopedic and spinal conditions account for about 3 in 10 opioid prescriptions, so surgeons can significantly reduce opioid-related deaths by limiting opioid prescriptions, says Dr. Okoroha.
Researchers created an approach to pain management that eliminated opioids after common sports surgeries.
In the first study, participants had undergone knee surgery to reconstruct their ACL. In the second study, participants had undergone surgery to repair their rotator cuff . All received a nerve block before surgery.
In each study, a group of participants received a standard opioid regimen to control pain. The other group participated in a non-opioid pain management approach. The non-opioid regimen included analgesics, nonsteroidal anti-inflammatory drugs, and muscle relaxants.
Both studies found that the non-opioid regimen provided at least the same pain control and patient satisfaction, if not more, compared to the standard opioid regimen.
In both studies, the most common side effects were drowsiness, dizziness, and gastrointestinal symptoms. In the rotator cuff study, participants who received the non-opioid regimen reported slightly fewer side effects than those who received the opioid regimen.
Dr. Okoroha says one way Mayo Clinic is working to limit opioids is to offer patients alternatives to traditional pain management.
"I think this is really game-changing research," says Dr. Okoroha. "We found it to be effective in common sports surgeries. So our plan is to implement it in other surgeries and hopefully decrease the burden of opioids worldwide."
