The use of a multimodal analgesia approach in a Randomized Clinical Trial including acetaminophen, ketorolac, gabapentin, and a neurogenic extremity block in patients undergoing major head and neck ablative and reconstructive surgery significantly reduced the need for opioids in the immediate postoperative period of a seven-day hospital stay. Coordination of care and reducing variability in pain medication administration were highly dependent on dissemination and implementation processes put in place for perioperative phases of care.
Objectives
To optimize the delivery of multimodal analgesia to patients undergoing major head and neck oncologic surgeries.
Methods
Pilot study included patients enrolled to receive either scheduled acetaminophen and as-needed opioids (control group) or scheduled acetaminophen, gabapentin, ketorolac, and as-needed opioids (experimental group). RCT, a hybrid type 1 effectiveness-implementation pragmatic trial, was designed to test the effectiveness of the intervention. Arm A received scheduled acetaminophen and as-needed opioids. Arm B received scheduled gabapentin, ketorolac, a regional nerve block at the free tissue donor site, scheduled acetaminophen and as-needed opioids.
Results
Pilot: Thirty-one patients undergoing major head and neck surgery were enrolled. Mean MMEs administered in control group (n = 15) was 251.60 mg (SD = 224.57 mg); mean MMEs in Experimental group (n = 16) was 195.78 mg (SD = 131.08 mg), p = 0.401. LOS was 8.0 days in control versus 7.0 days in experimental group (p = 0.054).
RCT: Interim analysis for safety and futility was planned during trial's design after 30 patients (n = 14 Arm A, and n = 16 Arm B). Mean MMEs administered were 135.1 mg in Arm A, (SD = 86.0 mg) versus mean MME of 51.3 mg in Arm B (SD = 43.3 mg, (p < 0.05)). Given clear superiority results, the trial was prematurely terminated. Functional pain scores, LOS, and complications were similar between the arms (p > 0.05). Variability of mean MME was compared before and after implementation of the management protocols: SD in RCT#1 was 181.46 mg versus 124.6 mg in RCT#2.
Conclusion
Multimodal analgesia significantly reduced the need for opioids in patients undergoing major head and neck surgery.
Level of Evidence
1, Randomized Clinical Trial Laryngoscope, 2022
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