Marko Zdravkovic1, Mirt Kamenik2. 1. Department of Anaesthesiology, Intensive Care and Pain Management, University Medical Centre Maribor, Ljubljanska ulica 5, 2000 Maribor, Slovenia; Faculty of Medicine, University of Maribor, Taborska ulica 8, 2000 Maribor, Slovenia. Electronic address: markozdravkovic@gmail.com. 2. Department of Anaesthesiology, Intensive Care and Pain Management, University Medical Centre Maribor, Ljubljanska ulica 5, 2000 Maribor, Slovenia; Faculty of Medicine, University of Maribor, Taborska ulica 8, 2000 Maribor, Slovenia.
Abstract
STUDY OBJECTIVE: We aimed to determine the magnitude of peri-operative opioid sparing effect when general anesthesia is combined with spinal analgesia for laparoscopic gynecological surgery. DESIGN: A prospective randomized controlled study; a three-group trial with two comparisons (each intervention group to control). SETTING: Operating room and postoperative recovery area. PATIENTS: Patients aged between 18 and 65 years with American Society of Anesthesiologists physical status 1 or 2 who were scheduled for inpatient elective laparoscopic gynecological surgery with expected pneumoperitoneum duration of at least 20 min. Of 102 randomized patients, 99 completed the study. INTERVENTIONS: Patients were randomized to general anesthesia alone (control group) or combined with very-low-dose (levobupivacaine 3.75 mg; sufentanil 2.5 μg) or low-dose (levobupivacaine 7.5 mg; sufentanil 2.5 μg) spinal analgesia. MEASUREMENTS: Primary endpoints were perioperative opioid consumption and pain scores (11-point numeric rating scale) at 30 min, 1 h, 2 h, 4 h and 24 h post-surgery. Secondary endpoints were patient satisfaction with anesthetic care and participation in research, sevoflurane consumption and adverse effects. MAIN RESULTS:Intra-operative sufentanil (median [95% CI]) consumption was 16.1 (10.5-22.6) μg/h in the control group versus 4.7 (3.2-9.2) μg/h in the very-low-dose and versus 2.9 (0.0-4.0) μg/h in the low-dose spinal analgesia groups (p < 0.001, for both comparisons). Median (95% CI) piritramide consumption at 24 h post-surgery was 7.5 (3-8) mg in the control group versus 5 (0-7.5) mg in the very-low dose spinal analgesia group (p = 0.182) and versus 2 (0-2.5) mg in the low-dose spinal analgesia group (p = 0.001). Postoperative pain scores were consistently <3 only in the low dose spinal analgesia group. Patient satisfaction with anesthetic care and participation in research was very high in all groups. CONCLUSIONS: Low-dose spinal analgesia in combination with general anesthesia reduces peri-operative opioid consumption in laparoscopic gynecological surgery in immediate postoperative period.
RCT Entities:
STUDY OBJECTIVE: We aimed to determine the magnitude of peri-operative opioid sparing effect when general anesthesia is combined with spinal analgesia for laparoscopic gynecological surgery. DESIGN: A prospective randomized controlled study; a three-group trial with two comparisons (each intervention group to control). SETTING: Operating room and postoperative recovery area. PATIENTS: Patients aged between 18 and 65 years with American Society of Anesthesiologists physical status 1 or 2 who were scheduled for inpatient elective laparoscopic gynecological surgery with expected pneumoperitoneum duration of at least 20 min. Of 102 randomized patients, 99 completed the study. INTERVENTIONS:Patients were randomized to general anesthesia alone (control group) or combined with very-low-dose (levobupivacaine 3.75 mg; sufentanil 2.5 μg) or low-dose (levobupivacaine 7.5 mg; sufentanil 2.5 μg) spinal analgesia. MEASUREMENTS: Primary endpoints were perioperative opioid consumption and pain scores (11-point numeric rating scale) at 30 min, 1 h, 2 h, 4 h and 24 h post-surgery. Secondary endpoints were patient satisfaction with anesthetic care and participation in research, sevoflurane consumption and adverse effects. MAIN RESULTS: Intra-operative sufentanil (median [95% CI]) consumption was 16.1 (10.5-22.6) μg/h in the control group versus 4.7 (3.2-9.2) μg/h in the very-low-dose and versus 2.9 (0.0-4.0) μg/h in the low-dose spinal analgesia groups (p < 0.001, for both comparisons). Median (95% CI) piritramide consumption at 24 h post-surgery was 7.5 (3-8) mg in the control group versus 5 (0-7.5) mg in the very-low dose spinal analgesia group (p = 0.182) and versus 2 (0-2.5) mg in the low-dose spinal analgesia group (p = 0.001). Postoperative pain scores were consistently <3 only in the low dose spinal analgesia group. Patient satisfaction with anesthetic care and participation in research was very high in all groups. CONCLUSIONS: Low-dose spinal analgesia in combination with general anesthesia reduces peri-operative opioid consumption in laparoscopic gynecological surgery in immediate postoperative period.