Transversus abdominis plane block with liposomal bupivacaine versus continuous epidural analgesia for major abdominal surgery: The EXPLANE randomized trial - 17/01/22
, Barak Cohen, M.D. a, c, Hesham Elsharkawy, M.D., MBA a, d, Kamal Maheshwari, M.D. a, b, Loran Mounir Soliman, M.D. b, Rovnat Babazade, M.D. e, Sabry Ayad, M.D. a, b, Manal Hassan, M.D. b, Nabil Elkassabany, M.D. f, Hani A. Essber, M.D. a, Hermann Kessler, M.D. g, Guangmei Mao, PhD a, h, Wael Ali Sakr Esa, M.D.,PhD a, b, Daniel I. Sessler, M.D. afor the EXPLANE Study Group
Abstract |
Objective |
Compare transversus abdominis plane (TAP) blocks with liposomal bupivacaine were to epidural analgesia for pain at rest and opioid consumption in patients recovering from abdominal surgery.
Background |
ERAS pathways suggest TAP blocks in preference to epidural analgesia for abdominal surgery. However, the relative efficacies of TAP blocks and epidural analgesia remains unknown.
Methods |
Patients having major abdominal surgery were enrolled at six sites and randomly assigned 1:1 to thoracic epidural analgesia or bilateral/4-quadrant TAP blocks with liposomal bupivacaine. Intravenous opioids were used as needed. Non-inferiority margins were a priori set at 1 point on an 11-point pain numeric rating scale for pain at rest and at a 25% increase in postoperative opioid consumption.
Results |
Enrollment was stopped per protocol at 3rd interim analysis after crossing an a priori futility boundary. 498 patients were analyzed (255 had TAP blocks and 243 had epidurals). Pain scores at rest in patients assigned to TAP blocks were significantly non-inferior to those given epidurals, with an estimated difference of 0.09 points (CI: −0.12, 0.30; noninferiority P < 0.001). Opioid consumption during the initial 3 postoperative days in TAP patients was not non-inferior to epidurals, with an estimated ratio of geometric means of 1.37 (CI: 1.05, 1.79; non-inferiority P = 0.754). However, the absolute difference was only 21 mg morphine equivalents over the 3 days. Patients with epidurals were more likely to experience mean arterial pressures <65 mmHg than those given TAP blocks: 48% versus 31%, P = 0.006.
Conclusion |
Pain scores at rest during the initial three days after major abdominal surgery were similar. Patients assigned to TAP blocks required more opioid then epidural patients but had less hypotension. Clinicians should reconsider epidural analgesia in patients at risk from hypotension.
Trial Registration: ClinicalTrials.gov Identifier: NCT02996227.
Le texte complet de cet article est disponible en PDF.Highlights |
• | Pain management included two separate outcomes: pain scores at rest, and total opioid consumption during the initial 72 postoperative hours. |
• | Opioid consumption was defined as the total amount used from the end of surgery until the third postoperative day, converted to morphine sulphate equivalents. |
• | Pain was assessed with a verbal response scale which ranges from 0 to 10 points, with 10 being worst. |
• | Pain scores at rest were recorded every 30 min for the first 2 postoperative hours, and then every 4 h while awake for 72 h. |
• | Pain scores and opioid consumption were recorded in patients' medical records by care-givers, and collected by investigators who also verified documentation in medical records. |
• | There were six secondary outcomes. |
• | (1) Opioid-related side effects, per the Opioid–Related Symptom Distress Scale (ORSDS)16 which was evaluated the first three postoperative mornings while patients remained hospitalized. |
• | (2) Recovery after anesthesia which was evaluated on the first and third morning with the Quality of Recovery scale (QoR).17 (3) Postoperative hospital length of stay, defined as time from the end of surgery to discharge from hospital. |
• | (4) Cost effectiveness of liposomal bupivacaine. |
• | (5) Activity, defined as the total duration of time patients spent sitting or standing, as determined by the mobile monitoring system during the initial 72 postoperative hours. |
• | (6) Hemodynamic instability, defined as mean arterial pressure (MAP) <55 mmHg or systolic blood pressure < 80 mmHg. |
• | Analyses of activity and hypotension were restricted to patients with continuous postoperative monitoring. |
• | There were also two a priori exploratory outcomes: 1) hypoxemic events, defined as area-under-the-curve for saturation < 90% among patients with continuous monitoring; and, 2) persistent postoperative incisional pain, defined by presence of pain at three months and its characteristics as determined by the DN4 Test18 and Modified Brief Pain Inventory (MBPI)19 questionnaires. |
Keywords : Transversus abdominis plane block, Liposomal bupivacaine, Epidural analgesia, Exparel, Abdominal surgery, TAP blocks
Plan
Vol 77
Article 110640- mai 2022 Retour au numéro
Article précédent
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