Evaluating the Predictive Value of a Short Preoperative Holistic Risk Factor Screening Questionnaire in Preventing Persistent Pain in Elective Adult Surgery: Study Protocol for a Prospective Observational Pragmatic Trial [PERISCOPE].

BACKGROUND

The global incidence of persistent pain after surgery is approximately 10%, with considerable clinical and socioeconomic impacts. Despite identifying many risk factors in its development and the challenging management of the often neuropathic pain complaints, preoperative recognition of high-risk patients in various surgical populations using a standardized risk factor assessment questionnaire is lacking. This study evaluates the predictive value of a short holistic risk factor screening questionnaire as a first step in preventing and treating persistent pain in adults undergoing elective surgery.

METHODS

This prospective observational pragmatic trial will include 560 adults undergoing elective surgery. The primary endpoint is the evaluation of the predictive value of the screening questionnaire, including the optimal cut-off determination in terms of sensitivity and specificity for inclusion in a perioperative high-vigilance program. Secondary endpoints are postoperative pain (intensity and characterization using the NRS and DN4), postoperative analgesic usage, and well-being using the EQ-5D-5 L. To assess the performance of the designed screening questionnaire in the identification of psychosocial pain aspects, HADs, and STAI-trait are being surveyed. Additionally, the multidimensional pain inventory (MPI, part 1) is being used to assess the impact of pain on daily life in patients.

DISCUSSION

This pragmatic clinical trial will evaluate a short preoperative screening questionnaire to predict persistent postoperative pain after elective surgery in adults. Suppose high-risk patients could be identified earlier using this short preoperative holistic screening questionnaire. In that case, it might contribute to a more widespread implementation of standardized preoperative assessment and awareness for preventing persistent postoperative pain.

TRIAL REGISTRATION

Local ethics committee: B3002022000112. ClinicalTrials.gov identifier: NCT05526976. Registered on: 02 September 2022. Start of recruitment: 22 December 2022.

TRIAL STATUS

This paper is based on protocol version 4.0. The first patient was assigned to the research project on the 22 of December 2022. We anticipate including the last patient in October 2023 and plan to finalize the study by January 2024.