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]

Abstract

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.

Keywords:

• persistent postsurgical pain
• neuropathic pain
• postoperative pain

Abbreviations

AUC, area under the curve; CTC, Clinical Trial Centre; DN4, Douleur neuropathic; GCP, good clinical practice; HADS, Hospital Anxiety and Depression Scale; MPI, Multidimensional Pain Inventory; NRS, Numeric Rating Scale; NSAIDs, Nonsteroidal anti-inflammatory drugs; PPSP, Persistent postsurgical pain; REDCap^®, Research Electronic Data Capture; STAI, State Trait Anxiety Inventory; SNRI, Serotonin-norepinephrine reuptake inhibitor; TCA, Tricyclic antidepressants.

Data Sharing Statement

The PI, statistical analyst, and data manager will have access to the final trial dataset. Data of participants will be collected in Redcap in the context of this study only and will be owned by the current researchers.

Ethics Approval and Consent

This study was approved by the UZA Ethics Committee, Edegem, Belgium, with reference B3002022000112. Written, informed consent to participate will be obtained from all participants.

Consent for Publication

We are willing to provide a model informed consent form upon request.

Acknowledgments

We would like to thank the team members of the multidisciplinary pain centre, clinical trial centre, and the preoperative consultation for their dedicated work.

Author Contributions

DW is the principal investigator (PI). She participated in study conception, design, execution and interpretation. She wrote, revised and reviewed the article. IM contributed to the study’s design and will contribute to the study result interpretation. She critically reviewed the manuscript. IV, EW and LVL contributed to the conception and study design and data collection. They drafted and substantially revised the manuscript. ER is involved as a statistician in the study design and analysis and interpretation of the study results. She critically reviewed and revised the manuscript. LVDV contributed to data collection and reviewed the article. RD, VS, and GH contributed to the design, organization, and draft preparations and will also contribute to the study results interpretation. Moreover, they are involved in revising the manuscript. All authors have read and approved the final draft of the study protocol. Furthermore, they have agreed on the journal to which the article will be submitted, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.

Disclosure

The authors declare that they have no competing interests.

Additional information

Funding

There is no funding to report.