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Double Blinded Randomized Placebo Controlled Study in Evaluating the Effectiveness of IV Acetaminophen for Acute Post Operative Pain in C-Section patients.
Abstract Number: T-23
Abstract Type: Original Research
With nearly a third of deliveries in the United States being via cesarean section (CS), pain management and other related post operative care are becoming an ever increasingly important topic. Post operative pain management after C-section is managed in the same multimodal manner as any other surgery. Any medication given to the mother should be very effective and at the same time free from side effects, not only for the mother but also for the newborn. We hypothesize that IV acetaminophen will reduce post operative opioid requirements and opioid associated complications.
The primary objective of the study was to evaluate the effectiveness of IV acetaminophen in reducing 24 hour opioid requirements in the CS patient population.
Secondary endpoints evaluated the effectiveness of IV acetaminophen in reducing the amount of rescue medications as well as reduce the Visual Analog Score (VAS pain score) in the two groups. Additionally, the sedation level in the two groups and the time till passing of first stool after the surgery were monitored. Lastly, the patient’s overall anesthesia satisfaction were compared.
This is a randomized, placebo-controlled study that assigned patients either to receive IV acetaminophen or a placebo. Full term CS patients aged 18 or above, who are classified as ASA I-III were consented during their pre-natal visits. On the day of C-section, hospital pharmacy, which was not part of the data collection, randomized the patients to one of the two groups.
As the routine standard of care, all the patients undergoing C-section received intrathecal 0.75% hyperbaric bupivicaine with morphine and fentanyl. Upon umbilical cord clamping in the OR or immediately after delivery; patients received the first dose of 1g IV acetaminophen (or placebo) followed by three more 1g doses every 6 hours. During the routine nursing evaluation, if the VAS pain score was greater than 5, rescue oxycodone per os was given every 2-4 hours until pain was controlled. If the pain was still uncontrolled, more opioid based pain medication was provided as per the discretion of the treating physician. Rescue pain medication was available for both groups. A research assistant who was blinded to the group assessed the pain score every 8 hours until 48 hours had passed since surgery. The amount of opioid required and patient level of sedation was recorded at the same interval. Additionally, patients were asked about other adverse events like nausea, vomiting, pruritus and breathing difficulties. On the day of discharge, the patients were asked for their overall pain management satisfaction level. All other adverse events recorded by the nurse were also collected.
This study was completed this week. Interim analysis was limited by the blinded nature of the study. At this time, unblinding and analysis will begin. We look forward to sharing all the findings when presented.