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| Name | Class |
|---|---|
| University of Kentucky | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Change in Pain Ratings (NRS) at the surgical site and at the mirror-site in the contralateral groin six to eight weeks after unilateral herniotomy following administration of placebo. |
|
| Target-controlled naloxone-infusion (total dose: 3.25 mg/kg) | Experimental | Change in Pain Ratings (NRS) at the surgical site and at the mirror-site in the contralateral groin six to eight weeks after unilateral herniotomy following administration of naloxone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Target-controlled naloxone-infusion | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Summated pain intensity | Change in pain ratings ([NRS,0-10] pain at rest + pain during transition from supine to standing position + pain during pressure (100 kPa) at injury site), assessed 6-8 weeks after unilateral, primary, open groin hernia repair following administration of naloxone/placebo. | 1st session: 6-8 weeks after surgery; 2nd session: one week later |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary hyperalgesia/allodynia | Change in secondary hyperalgesia area/allodynia at surgical site and at the mirror-site in the contralateral groin assessed 6-8 weeks after unilateral, primary, open groin hernia repair following administration of naloxone/placebo. | 1st session: 6-8 weeks after surgery; 2nd session: one week later |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Catastrophizing Scale | Patients fill out Pain Catastrophizing Scale before assessments on the first study day | in the 1st session: 6-8 weeks after surgery |
| Hospital Anxiety and Depression Scale | Patients fill out Hospital Anxiety and Depression Scale before assessments on the first study day |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mads U Werner, M.D., D.M.Sc. | Rigshospitalet, Denmark | Principal Investigator |
| Mads U Werner, M.D., D.M.Sc. | Rigshospitalet, Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multidisciplinary Pain Center, 7612, HOC, Rigshospitalet | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30915992 | Derived | Papathanasiou T, Springborg AD, Kongstad KT, Staerk D, Moller K, Taylor BK, Lund TM, Werner MU. High-dose naloxone, an experimental tool uncovering latent sensitisation: pharmacokinetics in humans. Br J Anaesth. 2019 Aug;123(2):e204-e214. doi: 10.1016/j.bja.2018.12.007. Epub 2019 Jan 18. | |
| 26554360 | Derived |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020886 | Somatosensory Disorders |
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| Drug |
|
| Pressure pain thresholds |
Change in pressure pain thresholds at surgical site and at the mirror-site in the contralateral groin assessed 6-8 weeks after unilateral, primary, open groin hernia repair following administration of naloxone/placebo. |
| 1st session: 6-8 weeks; 2nd session: one week later |
| in the 1st session: 6-8 weeks after surgery |
| Clinical Opiate Withdrawal Scale | Clinical Opiate Withdrawal Scale is filled out before and during naloxone/placebo administration in each experimental session | 1st session: 6-8 weeks after surgery; 2nd session: one week later |
| Pereira MP, Werner MU, Dahl JB. 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. Trials. 2015 Nov 10;16:511. doi: 10.1186/s13063-015-1021-6. |
| D012678 | Sensation Disorders |
| D009422 | Nervous System Diseases |