An upcoming pragmatic clinical trial will evaluate the efficacy of postoperative percutaneous peripheral nerve stimulation as a method of analgesia compared with standard opioid-based analgesia, according to a report published in Pain Medicine.
Researchers have initiated a randomized controlled pilot study examining percutaneous peripheral nerve stimulation for moderately to severely painful ambulatory orthopedic surgical procedures (ClinicalTrials.gov identifier NCT03481725). Investigators are seeking to determine the feasibility of percutaneous nerve stimulation to reduce postoperative opioid consumption within 7 days following surgery compared with usual analgesia techniques.
Secondary aims will include evaluating the effect of percutaneous peripheral nerve stimulation on physical and emotional functioning, chronic pain, and quality of life following surgery.
This study will be a multicenter, randomized, quadruple-masked, sham-controlled, parallel-arm, pragmatic clinical trial. Total enrollment includes 61 of an anticipated 64 participants and is hampered by the temporary suspension of elective surgeries due to coronavirus disease 2019 (COVID-19). Surgical procedures include rotator cuff repair, hallux valgus correction, and ankle arthrodesis or arthroplasty.
Within the 7 days prior to surgery, participants will have either a brachial plexus or subgluteal sciatic lead inserted via ultrasound guidance. After lead insertion, participants will be randomly assigned 1:1 to receive either an electric current or a sham treatment.
Postoperative treatment via stimulator will be initiated in the recovery room, and both verbal and written instructions will be provided to patients and caretakers, in addition to a prescription for immediate-release oxycodone 5 mg. Leads will be removed on postoperative day 14.
For this study, primary outcome measures include cumulative opioid use from the time of discharge through postoperative day 4 and mean value of “average” pain scores for postoperative days 0 through 7. A numeric rating scale will be used to assess current, worst, least, and average pain at the surgical site.
Secondary outcomes include physical and emotional functioning scores for percutaneous peripheral nerve stimulation vs usual care measured via the Brief Pain Inventory (Short Form) as well as the evaluation of chronic pain via the worst reported pain and quality of life via the World Health Organization Quality of Life-BREF.
“Current treatment for postsurgical pain overwhelmingly involves opioid analgesics,” the researchers wrote, adding that most ambulatory surgery patients are discharged with opioid prescriptions that exceed the required number of tablets due to the impossibility of predicting how many tablets an individual will require. Results of this practice include inadequate analgesia and undesired side effects like opioid abuse or addiction.
“We have attempted to balance the requirements [for pragmatic trials]…to produce a pragmatic effectiveness trial that will inform key stakeholders regarding this nonpharmacologic approach to the management of postoperative pain…that will concurrently provide evidence for the efficacy of this relatively new postoperative analgesic modality,” the researchers concluded.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Ilfeld BM, Gelfand H, Dhanjal S, et al. Ultrasound-guided percutaneous peripheral nerve stimulation: a pragmatic effectiveness trial of a nonpharmacologic alternative for the treatment of postoperative pain. Pain Med. 2020;21(Suppl 2):S53-S61. doi:10.1093/pm/pnaa332