Footnotes

• Contributors HJ, FRvT, SB, JGS, BJO and JJV contributed to the design and planning of the study. SB coordinated the study. Spine surgeons LMB, RG and PdB performed the surgeries, with LMB and RG as principal investigators at the participating hospitals. FRvT contributed to the statistical analyses. HJ compiled the full manuscript, which was critically reviewed by all authors, including MR. JJV is the guarantor.

• Funding Despite author affiliations with the funder SentryX, the results of this study were not influenced by the funder.

• Competing interests This research article describes results from a first-in-human phase Ib clinical trial as part of a drug development program. The study was sponsored by SentryX, a biopharmaceutical startup company, which was founded in 2017 as a spin-out of the University Medical Center Utrecht with the express goal of developing a non-opioid local pain treatment for spine fixation surgery. Authors HJ, FRvT, SB, JGS, BJO and JJV are all employees and/or own stocks in the SentryX company.

• Provenance and peer review Not commissioned; externally peer reviewed.

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