NCT01992146

Effect of High-dose Naloxone Infusion on Pain and Hyperalgesia in Patients Following Groin-Hernia Repair.

Completed Phase 2 Last updated 22 February 2024

What this trial tests

Phase 2 trial testing Target-controlled naloxone-infusion in Central Nervous System Sensitization in 9 participants. Completed in 11 May 2018.

Timeline

11 November 2015

Primary endpoint
14 December 2015

11 May 2018

Quick facts

Lead sponsor	Rigshospitalet, Denmark
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	basic science
Enrollment	9
Start date	11 November 2015
Primary completion	14 December 2015
Estimated completion	11 May 2018
Sites	1 location across Denmark

Drugs / interventions tested

• Target-controlled naloxone-infusion — full drug profile →
• Placebo

Conditions studied

• Central Nervous System Sensitization — all drugs for Central Nervous System Sensitization →
• Pain — all drugs for Pain →
• Hyperalgesia — all drugs for Hyperalgesia →

Sponsor

Rigshospitalet, Denmark

Who can join

Adults 18 to 65, male only, with Central Nervous System Sensitization or Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Recent studies have focused on the role of endogenous opioids on central sensitization. Central sensitization is known to be impaired or altered in chronic pain conditions, as fibromyalgia or chronic tension headache.

Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone administration after resolution of an injury. This suggests latent sensitization.

In the present study, investigators hypothesize that a high-dose target-controlled naloxone infusion (total dose: 3.25 mg/kg) can reinstate pain and hyperalgesia 6-8 weeks after a unilateral primary open groin hernia repair procedure. Investigators aim to show that latent sensitization is present in humans and is modulated by endogenous opioids.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. High-dose naloxone, an experimental tool uncovering latent sensitisation: pharmacokinetics in humans.
   Papathanasiou T, Springborg AD, Kongstad KT, Staerk D, et al · · 2019 · cited 9× · PMID 30915992 · DOI 10.1016/j.bja.2018.12.007
2. Effect of a high-dose target-controlled naloxone infusion on pain and hyperalgesia in patients following groin hernia repair: study protocol for a randomized controlled trial.
   Pereira MP, Werner MU, Dahl JB. · · 2015 · cited 8× · PMID 26554360 · DOI 10.1186/s13063-015-1021-6