BACKGROUND: The objectives of this study were to compare the incidence, onset, duration and pain scores of transient neurologic symptoms (TNS) with 1% versus 5% hyperbaric lidocaine in spinal anesthesia for short urological procedures in a large prospective study. This study would also evaluate patient satisfaction, and impact of TNS on functional recovery to assess the clinical significance of TNS. METHODS: This was a multicenter, double-blind, randomized controlled trial. Four hundred fifty-three patients undergoing short transurethral procedures were randomized to receive 1% or 5% hyperbaric lidocaine. Eighty milligrams of 1% or 5% hyperbaric lidocaine was administered. During the first 3 days after surgery, the presence of TNS, its intensity and duration, and patient functional level were recorded. An intention-to-treat analysis was used. RESULTS: There was no difference in the incidence of TNS (21% vs. 18%) between 1% versus 5% lidocaine. Patients with TNS had significantly higher pain scores (5.3 +/- 3 vs. 2.3 +/- 3) than patients without TNS during the first 24 h. This difference in pain scores persisted until 72 h postoperatively. There was a significant difference in the daily activities functional scores (2.2 +/- 1 vs. 1.4 +/- 0.8) of TNS non-TNS patients during the first 24 h postoperatively. CONCLUSIONS: There was no difference in the incidence of TNS between the 1% versus 5% spinal lidocaine groups. Pain scores were higher in patients with TNS than those who did not have TNS. During the first 48 h postop, a small proportion of patients who had TNS experienced functional impairment of walking, sitting, and sleeping.
RCT Entities:
BACKGROUND: The objectives of this study were to compare the incidence, onset, duration and pain scores of transient neurologic symptoms (TNS) with 1% versus 5% hyperbaric lidocaine in spinal anesthesia for short urological procedures in a large prospective study. This study would also evaluate patient satisfaction, and impact of TNS on functional recovery to assess the clinical significance of TNS. METHODS: This was a multicenter, double-blind, randomized controlled trial. Four hundred fifty-three patients undergoing short transurethral procedures were randomized to receive 1% or 5% hyperbaric lidocaine. Eighty milligrams of 1% or 5% hyperbaric lidocaine was administered. During the first 3 days after surgery, the presence of TNS, its intensity and duration, and patient functional level were recorded. An intention-to-treat analysis was used. RESULTS: There was no difference in the incidence of TNS (21% vs. 18%) between 1% versus 5% lidocaine. Patients with TNS had significantly higher pain scores (5.3 +/- 3 vs. 2.3 +/- 3) than patients without TNS during the first 24 h. This difference in pain scores persisted until 72 h postoperatively. There was a significant difference in the daily activities functional scores (2.2 +/- 1 vs. 1.4 +/- 0.8) of TNS non-TNSpatients during the first 24 h postoperatively. CONCLUSIONS: There was no difference in the incidence of TNS between the 1% versus 5% spinal lidocaine groups. Pain scores were higher in patients with TNS than those who did not have TNS. During the first 48 h postop, a small proportion of patients who had TNS experienced functional impairment of walking, sitting, and sleeping.