OBJECTIVE: An alternative to general anesthesia was tested against conventional sedation by a double-blind, randomized clinical trial in reduction of Colles fracture. SETTINGS: A large teaching hospital where cases of Colles fracture are not different from those seen in district hospitals. PATIENTS: Sixty-six out of 80 consecutive cases with this fracture were selected from March to August 1990 on the basis of: 1) informed consent; 2) no contraindication to any method of analgesia; 3) no analgesic during the past 8 hours; 4) injury duration less than 96 hours; 5) no mental, auditory, or visual impairment; and 6) no associated injury. INTERVENTIONS: Patients were randomized into 2 equal groups. After tests for Xylocaine (Astra brand of lidocaine hydrochloride) sensitivity in both groups, the A group received 30 mg of pentazocine with 5 mg of diazepam intravenously on the dorsum of the affected wrist (sedation group), whereas the B group received 20 cc of 1.5% Xylocaine into the fracture hematoma. Five minutes later the fracture was reduced and immobilized by Lakhtakia or A. Singh. MAIN OUTCOME MEASURES: Thirteen to 15 hours later Manglik, blinded to the analgesia status of the patient, recorded pain before, during, and after reduction using Visual Analogue Scale (VAS). MAIN RESULTS: Statistically, randomization and blinding were found to be effective. The pain scores during reduction in the local anesthetic group (median = 1.8) were significantly less than those in the sedation group (median = 8.7), P < 0.001 using the Wilcoxon rank sum test. The difference persisted in regression analysis. The 2 methods proved comparable in safety and other measures of effectiveness. CONCLUSIONS: Hematoma block by local anesthetic is a safe and effective alternative to sedation in reduction of Colles fracture.
RCT Entities:
OBJECTIVE: An alternative to general anesthesia was tested against conventional sedation by a double-blind, randomized clinical trial in reduction of Colles fracture. SETTINGS: A large teaching hospital where cases of Colles fracture are not different from those seen in district hospitals. PATIENTS: Sixty-six out of 80 consecutive cases with this fracture were selected from March to August 1990 on the basis of: 1) informed consent; 2) no contraindication to any method of analgesia; 3) no analgesic during the past 8 hours; 4) injury duration less than 96 hours; 5) no mental, auditory, or visual impairment; and 6) no associated injury. INTERVENTIONS:Patients were randomized into 2 equal groups. After tests for Xylocaine (Astra brand of lidocaine hydrochloride) sensitivity in both groups, the A group received 30 mg of pentazocine with 5 mg of diazepam intravenously on the dorsum of the affected wrist (sedation group), whereas the B group received 20 cc of 1.5% Xylocaine into the fracture hematoma. Five minutes later the fracture was reduced and immobilized by Lakhtakia or A. Singh. MAIN OUTCOME MEASURES: Thirteen to 15 hours later Manglik, blinded to the analgesia status of the patient, recorded pain before, during, and after reduction using Visual Analogue Scale (VAS). MAIN RESULTS: Statistically, randomization and blinding were found to be effective. The pain scores during reduction in the local anesthetic group (median = 1.8) were significantly less than those in the sedation group (median = 8.7), P < 0.001 using the Wilcoxon rank sum test. The difference persisted in regression analysis. The 2 methods proved comparable in safety and other measures of effectiveness. CONCLUSIONS:Hematoma block by local anesthetic is a safe and effective alternative to sedation in reduction of Colles fracture.