Pregabalin and Persistent Postoperative Pain Following Posterior Spinal Fusion in Children and Adolescents: A Randomized Clinical Trial.

Abstract

Surgical correction of spinal deformity requires major surgical intervention with extensive manipulation of the spine and neural elements. Persistent postoperative pain affects patient quality of life and can also cause financial burden for patient families and for society. We aimed to investigate the effect of perioperative pregabalin on the incidence of persistent pain following instrumented spinal fusion. We conducted a randomized, double-blinded, and placebo-controlled single-center clinical trial. Adolescents and children 10 to 21 years old with a spinal deformity who were scheduled for pedicle screw instrumentation and fusion were randomized into either the pregabalin or placebo group. Patients received 2 mg/kg of pregabalin or a placebo twice daily preoperatively and for 5 days postoperatively. The duration of follow-up was 2 years. The primary outcomes were cumulative opioid consumption during the first 48 hours postoperatively and the incidence of persistent postoperative pain over the course of the 2-year follow-up. Sixty-four of 77 eligible patients were enrolled in the study, with all patients completing the 2-year follow-up. Thirty-three patients were randomized into the pregabalin group and 31 into the placebo group. There was no significant difference in cumulative 48-hour opioid consumption between the study groups. The Scoliosis Research Society 24-Item Questionnaire pain domain score improved significantly, from a mean value of 3.8 in both groups to 4.3 in the pregabalin and 4.0 in the placebo group at 2 years postoperatively, with no differences between the study groups at any time point (p = 0.317). The Scoliosis Research Society total scores of the study groups were similar (p = 0.678). Back pain, as measured with use of a visual analogue scale, improved significantly (p = 0.001) with no significant differences at any time point (preoperatively and 6 months, 1 year, and 2 years postoperatively). Perioperative pregabalin does not reduce postoperative opioid consumption or the incidence of persistent postoperative pain following instrumented posterior spinal fusion for spinal deformities in an adolescent population. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.