Effect of individualized anesthesia and analgesia on postoperative pain in patients stratified for pain sensitivity: A study protocol for the PeriOPerative individualization trial randomized controlled trial

BACKGROUND: Despite advancements in surgical and anesthesia techniques, acute and persistent postoperative pain are still a common challenge. Postoperative pain has direct effects on individual patient care and outcome, as well as putting strain on limited health care resources. Several prediction methods for postoperative pain have been described. One such method is the assessment of pain during peripheral venous cannulation (VCP). It is not known if different approaches to anesthesia and analgesia, depending on the evaluation of risk for postoperative pain, can improve outcome. The aim of this study is to evaluate if individualized anesthesia and analgesia can affect postoperative pain and recovery after surgery, in patients stratified by VCP.

METHODS: Adult patients scheduled for laparoscopic surgery undergo pain-sensitivity stratification using VCP on the day of surgery. Patients scoring VCP ≥2.0 on the visual analogue scale (pain-sensitive) are randomized to multimodal anaesthesia and analgesia with opioids or standard of care. Patients scoring VCP ≤1.9 (pain-tolerant) are randomized to opioid-free anaesthesia or standard of care. The primary outcome is acute postoperative pain measured with numeric rating scale in the postoperative care unit. Secondary outcomes include analysis of pain after 24 h, persistent postoperative pain and quality of recovery.

DISCUSSION: Individualized perioperative pain management has the potential to improve patient care. This study will examine the impact of different anesthesia and analgesia regimes, in patients with differing pain sensitivity, on postoperative pain.

TRIAL REGISTRATION: Prospectively posted at ClinicalTrials.gov, identifier NCT04751812.