BACKGROUND: The study was designed to compare local anaesthesia and conscious sedation for outpatient bipolar operative hysteroscopy in terms of pain control and patients' satisfaction. METHODS: A prospective multicentre randomized study was carried out in university hospitals and in a private endoscopy unit. A total of 166 women with surgically treatable lesions associated with infertility or abnormal uterine bleeding was considered eligible for the study. Patients were randomized, using a computer-generated randomization list, into two groups. Group A (82 patients) underwent operative hysteroscopy with local anaesthesia. Group B (84 patients) received conscious sedation. Operative hysteroscopy was performed with a bipolar electrosurgical device to cut, vaporize and coagulate. Main outcome measures were pain control during the procedure, the post-operative pain score at 15 and 60 min, and at 24 h after the procedure, and patients' satisfaction rate. RESULTS: All procedures were completed within 35 min, the amount of saline used varied from 400-1200 ml. There were no significant differences between local anaesthesia and conscious sedation in terms of pain control during the procedure and in postoperative pain at different intervals. Satisfaction rate was similar in the two groups. CONCLUSIONS: Both local anaesthesia and conscious sedation can be used for operative hysteroscopy using a bipolar electrosurgical system without significant differences in terms of pain control and patients' satisfaction.
RCT Entities:
BACKGROUND: The study was designed to compare local anaesthesia and conscious sedation for outpatient bipolar operative hysteroscopy in terms of pain control and patients' satisfaction. METHODS: A prospective multicentre randomized study was carried out in university hospitals and in a private endoscopy unit. A total of 166 women with surgically treatable lesions associated with infertility or abnormal uterine bleeding was considered eligible for the study. Patients were randomized, using a computer-generated randomization list, into two groups. Group A (82 patients) underwent operative hysteroscopy with local anaesthesia. Group B (84 patients) received conscious sedation. Operative hysteroscopy was performed with a bipolar electrosurgical device to cut, vaporize and coagulate. Main outcome measures were pain control during the procedure, the post-operative pain score at 15 and 60 min, and at 24 h after the procedure, and patients' satisfaction rate. RESULTS: All procedures were completed within 35 min, the amount of saline used varied from 400-1200 ml. There were no significant differences between local anaesthesia and conscious sedation in terms of pain control during the procedure and in postoperative pain at different intervals. Satisfaction rate was similar in the two groups. CONCLUSIONS: Both local anaesthesia and conscious sedation can be used for operative hysteroscopy using a bipolar electrosurgical system without significant differences in terms of pain control and patients' satisfaction.