PURPOSE: To assess the safety and efficacy of intraosseous lidocaine (IL), in comparison with iv nalbuphine and propacetamol (NP) for analgesia during percutaneous vertebroplasty (PV) in order to avoid general anesthesia in elderly patients. METHODS:Patients (age 68 +/- 13 yr, weight 66 +/- 6 kg) undergoing PV for osteoporotic fractures were randomized prospectively into two groups: NP (n=50) and IL (n=50). All patients were premedicated (oral hydroxyzine 1 mg.kg(-1)) and had skin infiltration with 5 mL of 1% lidocaine prior to vertebral puncture. Thirty minutes before the procedure, Group NP received, in a blinded manner, 50 mL of iv nalbuphine (0.3 mg.kg(-1)) and propacetamol (30 mg.kg(-1)) while Group IL received 50 mL of iv saline. During vertebral puncture, Groups NP and IL received, in a blinded manner, 1 mL.10 kg(-1) of intraosseous saline and 1% lidocaine respectively. Pain was assessed during vertebral puncture and cement injection with a four-point verbal rating scale. Additionally, lidocaine plasma kinetics were obtained in 11 IL patients. RESULTS:Analgesic efficacy was similar in the IL and NP groups (85 vs 84%). Group NP had more side effects. Lidocaine peak recorded concentration was 2.6 +/- 0.1 microg.mL(-1) i.e., about three times less than the reported toxic limits. CONCLUSION: IL is as effective as the association of iv NP for analgesia in PV. However, considering that both protocols were insufficient in about 15% of cases, other modalities are needed to further improve analgesia and avoid general anesthesia during vertebroplasty.
RCT Entities:
PURPOSE: To assess the safety and efficacy of intraosseous lidocaine (IL), in comparison with iv nalbuphine and propacetamol (NP) for analgesia during percutaneous vertebroplasty (PV) in order to avoid general anesthesia in elderly patients. METHODS:Patients (age 68 +/- 13 yr, weight 66 +/- 6 kg) undergoing PV for osteoporotic fractures were randomized prospectively into two groups: NP (n=50) and IL (n=50). All patients were premedicated (oral hydroxyzine 1 mg.kg(-1)) and had skin infiltration with 5 mL of 1% lidocaine prior to vertebral puncture. Thirty minutes before the procedure, Group NP received, in a blinded manner, 50 mL of iv nalbuphine (0.3 mg.kg(-1)) and propacetamol (30 mg.kg(-1)) while Group IL received 50 mL of iv saline. During vertebral puncture, Groups NP and IL received, in a blinded manner, 1 mL.10 kg(-1) of intraosseous saline and 1% lidocaine respectively. Pain was assessed during vertebral puncture and cement injection with a four-point verbal rating scale. Additionally, lidocaine plasma kinetics were obtained in 11 IL patients. RESULTS: Analgesic efficacy was similar in the IL and NP groups (85 vs 84%). Group NP had more side effects. Lidocaine peak recorded concentration was 2.6 +/- 0.1 microg.mL(-1) i.e., about three times less than the reported toxic limits. CONCLUSION: IL is as effective as the association of iv NP for analgesia in PV. However, considering that both protocols were insufficient in about 15% of cases, other modalities are needed to further improve analgesia and avoid general anesthesia during vertebroplasty.