BACKGROUND: Despite 30 years of clinical research, we still do not know the optimal dose of intrathecal morphine (ITM) when used alone. OBJECTIVES: A safety investigation and comparison of the analgesic efficacy of ITM 0.2 mg, 0.5 mg, and 1 mg in patients undergoing major abdominal cancer surgery. STUDY DESIGN: A randomized, double-blind trial. SETTING: Academic medical center. METHODS:Ninety patients were randomly assigned to receive morphine intrathecally either 0.2 mg (Group I, ITM 0.2 mg, n = 30), 0.5 mg (Group II, ITM 0.5 mg, n = 30), or 1 mg (Group III, ITM 1 mg, n = 30) dissolved in 5 mL physiological saline before general anesthesia. Assessment parameters included hemodynamics, respiratory rate, peripheral arterial oxygenation, sedation score, pain severity, time of first analgesic request, total analgesic consumption, and side effects in the first 72 hours. RESULTS: The mean time to first request for rescue analgesia was significantly prolonged in Group II (22.13 ± 5.21 hours, P < 0.001) and Group III (30.83 ± 4.89 h, P < 0.001), compared with Group I (0.50 ± 0.66 hours). The mean tramadol consumption dose was significantly reduced in Group II (383.33 ± 91.28 mg, P < 0.001) and Group III (300 ± 69.48 mg, P < 0.001) compared with Group I (770 ± 114.92 mg). Patients received 1 mg ITM showed lower VAS scores in the first 48 h postoperative (P < 0.04) compared with Group I and Group II. No significant differences were observed in the mean systolic and diastolic blood pressure values, respiratory rate, and peripheral arterial oxygen saturation between groups. Lower mean heart rate values were observed in Group III patients at 6 hours (P < 0.01) and 12 hours (P < 0.03) postoperative compared with Group I and Group II patients. Six patients (20%) in Group II and 8 (26.7%) in Group III exhibited pruritus compared with 2 patients (6.66%) in Group I (P < 0.01). No intergroup statistical differences were observed for other studied side effects. LIMITATIONS: This study is limited by its small sample size. CONCLUSION: One mg ITM provided superior analgesia for 48 hours postoperative compared with 0.2 mg and 0.5 mg ITM with a nonsignificant difference in the incidence of side effects. Further studies of larger sample size are recommended to confirm these findings.
RCT Entities:
BACKGROUND: Despite 30 years of clinical research, we still do not know the optimal dose of intrathecal morphine (ITM) when used alone. OBJECTIVES: A safety investigation and comparison of the analgesic efficacy of ITM 0.2 mg, 0.5 mg, and 1 mg in patients undergoing major abdominal cancer surgery. STUDY DESIGN: A randomized, double-blind trial. SETTING: Academic medical center. METHODS: Ninety patients were randomly assigned to receive morphine intrathecally either 0.2 mg (Group I, ITM 0.2 mg, n = 30), 0.5 mg (Group II, ITM 0.5 mg, n = 30), or 1 mg (Group III, ITM 1 mg, n = 30) dissolved in 5 mL physiological saline before general anesthesia. Assessment parameters included hemodynamics, respiratory rate, peripheral arterial oxygenation, sedation score, pain severity, time of first analgesic request, total analgesic consumption, and side effects in the first 72 hours. RESULTS: The mean time to first request for rescue analgesia was significantly prolonged in Group II (22.13 ± 5.21 hours, P < 0.001) and Group III (30.83 ± 4.89 h, P < 0.001), compared with Group I (0.50 ± 0.66 hours). The mean tramadol consumption dose was significantly reduced in Group II (383.33 ± 91.28 mg, P < 0.001) and Group III (300 ± 69.48 mg, P < 0.001) compared with Group I (770 ± 114.92 mg). Patients received 1 mg ITM showed lower VAS scores in the first 48 h postoperative (P < 0.04) compared with Group I and Group II. No significant differences were observed in the mean systolic and diastolic blood pressure values, respiratory rate, and peripheral arterial oxygen saturation between groups. Lower mean heart rate values were observed in Group III patients at 6 hours (P < 0.01) and 12 hours (P < 0.03) postoperative compared with Group I and Group II patients. Six patients (20%) in Group II and 8 (26.7%) in Group III exhibited pruritus compared with 2 patients (6.66%) in Group I (P < 0.01). No intergroup statistical differences were observed for other studied side effects. LIMITATIONS: This study is limited by its small sample size. CONCLUSION: One mg ITM provided superior analgesia for 48 hours postoperative compared with 0.2 mg and 0.5 mg ITM with a nonsignificant difference in the incidence of side effects. Further studies of larger sample size are recommended to confirm these findings.
Authors: David Cosgrave; Marie Galligan; Era Soukhin; Victoria McMullan; Siobhan McGuinness; Anand Puttappa; Niamh Conlon; John Boylan; Rabia Hussain; Peter Doran; Alistair Nichol Journal: Trials Date: 2017-12-29 Impact factor: 2.279
Authors: Seung-Rim Han; Chul Seung Lee; Jung Hoon Bae; Hyo Jin Lee; Mi Ran Yoon; Do Sang Lee; Yoon Suk Lee; Abdullah Al-Sawat; Jung-Woo Shim; Sang-Hyun Hong; In Kyu Lee Journal: Ann Surg Treat Res Date: 2021-10-01 Impact factor: 1.859