Efficacy of intraoperative sedation combined with preemptive analgesia for single-level kyphoplasty under local anesthesia: A randomized clinical trial.

Background: Kyphoplasty is widely used for Osteoporotic Vertebral Compression Fracture (OVCF) under general or local anesthesia, more attention was paid to its post-operative efficacy. Patients' pain and discomfort control strategies during surgery have not been taken seriously.

Objective: This study aimed at assessing the efficacy of preoperative preemptive analgesia combined with intraoperative sedation for pain and tension relief in OVCF patients undergoing kyphoplasty under local anesthesia.

Methods: We enrolled 128 patients with single-level OVCF who underwent kyphoplasty in our hospital from July 2013 to July 2016. The patients were randomly allocated into three groups: conventional group (i.e., local anesthesia with 0.5% lidocaine (1); n = 42), preemptive group (i.e, (1) + oral 200 mg Celecoxib on the night before surgery with intravenous 40 mg parecoxib sodium an hour before surgery (2); n = 43), and combined group (i.e., (1) + (2) + continuous intravenous 0.5 μg/kg/h dexmedetomidine intraoperatively; n = 43). Hemodynamic variations (heart rate, blood pressure, pulse oxygen saturation (SpO)), Pain Visual Analogue Score (VAS), Ramsay score, and adverse events were recorded during perioperative period.

Results: Blood pressure and heart rate were more stable with significantly smaller values in the combined group than in the conventional and preemptive groups both intra- and postoperatively. In contrast, SpO showed no significant difference among the groups throughout the perioperative period. Intraoperative VAS scores revealed significant differences among the groups with the combined group having the smallest values followed by the preemptive group. Similarly, intraoperative Ramsay scores reflected significantly more favorable effects of sedation in the combined than in conventional group. Both VAS and Ramsay scores showed no significant differences among the groups postoperatively, and no differences in complication incidences were noted among the groups as well.

Conclusions: For kyphoplasty under local anesthesia for single-level OVCF, intraoperative sedation combined with preemptive analgesia worked better in mitigating pain and tension intraoperatively and in preventing hemodynamic changes intra- and post-operatively, as compared to local anesthesia alone or additional preemptive analgesia.