Surgical correction of spinal deformities is major surgery with extensive manipulation of the spine and neural elements. Persistent postsurgical pain affects the patients` quality of life and can also cause financial burden for families and community. We aimed to investigate the effects of perioperative pregabalin on the incidence of persistent pain after instrumented spinal fusion.
Methods:The study design was a randomized, double-blind and placebo-controlled single center clinical trial. Adolescents and children aged 10 -21 years, with a spinal deformity scheduled for pedicle screw instrumentation and fusion were randomized in pregabalin or placebo group. The study subjects received preoperatively and five days after surgery pregabalin 2 mg/kg or placebo twice daily. Duration of follow-up was 2 years. The primary outcomes were cumulative oxycodone consumption during the first 48 postoperative hours and the incidence of persistent postsurgical pain during 2-year follow-up.
Results:Out of 77 eligible patients 64 were enrolled in the study with all patients completing 2-year follow-up. Thirty-three patients were randomized into pregabalin group and 31 patients into placebo group. There was no statistically significant difference in the cumulative 48-hour oxycodone consumption between the study groups. The SRS-24 pain domain score showed a significant improvement from a mean value of 3.8 in both groups to 4.3 in the pregabalin and 4.0 in the placebo group during the 2-year FU with no differences between the study groups at any time point (p=0.317). The SRS-24 total scores were similar in the study groups (p=0.678). Back pain on a visual analogue scale improved significantly from preoperative 3 value during the two-year follow-up (p=0.0011) with no significant differences at any time point (preoperative, 6-month, 1 year and 2 year).
Conclusions:Perioperative pregabalin does not reduce the postoperative opioid consumption nor the incidence of persistent postsurgical pain among adolescents after instrumented posterior spinal fusion for spinal deformities.