NCT03493490.

Study name	Neodolpasse infusion solution versus diclofenac 75 mg infusion in the treatment of postoperative pain after elective knee surgery
Methods	Placebo‐ and active‐controlled, triple‐blind, parallel‐group, single‐center exploratory phase 4 study. Outcomes assessed over the first 48 h postsurgery. Participant randomization takes place postsurgery as soon as the participant is able to adequately co‐operate. Ability to co‐operate is defined as successful VAS assessment. The first infusion of the intervention is started immediately after randomization.
Participants	Type of surgery: cruciate ligament repair or knee replacement. Estimated enrollment: 72 participants
Interventions	Diclofenac: 75 mg/250 mL IV administered over 30 minutes as soon as participant is able to complete a VAS assessment postsurgery. Dose repeated 8 h later. Placebo: 250 mL 0.9% sodium chloride, as with diclofenac Diclofenac/orphenadrine: Diclofenac 75 mg + orphenadrine 30 mg/250 mL, as with diclofenac
Outcomes	Primary: Total dose of patient‐controlled analgesia hydromorphone required over the first 24 hours postsurgery. Measured in numbers of boli as well as milligrams. Secondary: Pain relief during the infusion periods and until 48 h after the intervention using a VAS
Starting date	1 March 2018
Contact information	Oliver Kimberger, MD; study@kimberger.at
Notes	No mention of minimum pain intensity requirement for inclusion. Unclear if data assessed over 4‐ to 6‐hour period postintervention.

IV: intravenous; VAS: visual analogue scale.