Comparison of cumulative opioid consumption between variable-rate feedback infusion and fixed-rate basal infusion modes of intravenous patient-controlled analgesia following mixed surgery: protocol for a prospective randomised controlled trial
Abstract
Introduction: Inadequately managed postoperative pain remains a significant clinical challenge, often leading to delayed mobilisation and increased complications. While intravenous patient-controlled analgesia (PCA) is a mainstay of treatment, conventional fixed-rate basal infusion modes may not align with the fluctuating biphasic nature of postoperative pain. This often results in either insufficient analgesia or unnecessary opioid overexposure. Advanced network-integrated PCA pumps now allow for 'variable-rate feedback infusion,' which dynamically adjusts the background rate based on real-time patient demand. This study aims to determine whether a variable-rate feedback infusion mode reduces total cumulative opioid consumption at 48 hours postoperatively while providing non-inferior analgesic efficacy compared with a fixed-rate basal infusion mode.
Methods and analysis: This is a multicentre, randomised, double-blind, controlled trial to be conducted at three hospitals in China. A total of 1170 patients (aged 18-65 years, American Society of Anaesthesiologists I-III) undergoing elective mixed surgery under general anaesthesia, including thoracic, abdominal, spinal, orthopaedic and cranial procedures performed using either minimally invasive or open approaches, will be recruited and randomised in a 1:1 ratio to either the fixed-rate basal infusion group or the variable-rate feedback infusion group. Both groups will receive a standardised PCA solution of sufentanil. In the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,170 participants or records.
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