Analgesic Effect of Oxytocin Receptor Modulation

NCT01918475 | Completed DMC

• 2 other identifiers: 140/122013DR1021
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Carbetocin is a synthetic analogue of the hormone Oxytocin and is routinely used in obstetric anesthesiology to control uterine bleeding after cesarean section. As an incidental finding, women who received carbetocin had less pain after cesarean section than women who had received Oxytocin. Carbetocin may therefore have an analgesic effect. The present study examines this analgesic effect using different sensory tests, e.g. pressure, heat, cold and electrical pain before and after administration of carbetocin in healthy male volunteers. Any changes in these sensory tests might be indicative of an analgesic property of carbetocin.

Conditions

Pain; Hyperalgesia; Central Sensitization

Keywords

randomized controlled trial; placebo controlled trial; cross over trial

Outcome Measures

Primary Outcomes (1)

• Change in intramuscular electrical pain threshold compared to baseline

  10, 60 and 120 minutes after carbeoticin administration

Secondary Outcomes (7)

• Capsaicin-induced area of hyperalgesia and allodynia

  10, 60 and 120 minutes after carbeoticin administration

• Nociceptive withdrawal reflex thresholds of the foot

  10, 60 and 120 minutes after carbeoticin administration

• Single cutaneous electrical pain thresholds

  10, 60 and 120 minutes after carbeoticin administration

• Repeated cutaneous electrical pain thresholds

  10, 60 and 120 minutes after carbeoticin administration

• Single intramuscular electrical pain threshold

  10, 60 and 120 minutes after carbeoticin administration

Study Arms (2)

Carbetocin first

ACTIVE COMPARATOR

Subjects receive carbetocin 0.1 mg intravenously in the first session and placebo (NaCl 0.9%) in the second session

Drug: Carbetocin; Drug: Placebo

Placebo first

ACTIVE COMPARATOR

Subjects receive placebo (NaCl 0.9%) intravenously in the first session and carbetocin 0.1 mg in the second session

Drug: Carbetocin; Drug: Placebo

Interventions

Carbetocin DRUG

Carbetocin 0.1 mg single dose is intravenously administered

Carbetocin first; Placebo first

Placebo DRUG

1ml of NaCl 0.9% is administered intravenously

Carbetocin first; Placebo first

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male
• pain-free
• written informed consent

You may not qualify if:

• chronic pain
• acute pain at time of testing
• sign or suspicion of neurological dysfunction at the tested sites
• intake of opioids
• intake of benzodiazepines
• intake of antidepressants
• intake of anticonvulsants
• intake of any analgesic drug 48h prior to test
• known allergy to carbetocin
• allergy to capsaicin
• cardiovascular disease
• asthma bronchiale
• migraine
• epilepsy
• history of liver disease

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Department of Anesthesiology and Pain Therapy, Bern University Hospital

Bern, Canton of Bern, 3010 Bern, Switzerland

Location

Related Publications (3)

• De Bonis M, Torricelli M, Leoni L, Berti P, Ciani V, Puzzutiello R, Severi FM, Petraglia F. Carbetocin versus oxytocin after caesarean section: similar efficacy but reduced pain perception in women with high risk of postpartum haemorrhage. J Matern Fetal Neonatal Med. 2012 Jun;25(6):732-5. doi: 10.3109/14767058.2011.587920. Epub 2011 Jul 15.

  PMID: 21761999 BACKGROUND

• Rousselot P, Papadopoulos G, Merighi A, Poulain DA, Theodosis DT. Oxytocinergic innervation of the rat spinal cord. An electron microscopic study. Brain Res. 1990 Oct 8;529(1-2):178-84. doi: 10.1016/0006-8993(90)90825-v.

  PMID: 2282492 BACKGROUND

• Breton JD, Veinante P, Uhl-Bronner S, Vergnano AM, Freund-Mercier MJ, Schlichter R, Poisbeau P. Oxytocin-induced antinociception in the spinal cord is mediated by a subpopulation of glutamatergic neurons in lamina I-II which amplify GABAergic inhibition. Mol Pain. 2008 May 29;4:19. doi: 10.1186/1744-8069-4-19.

  PMID: 18510735 BACKGROUND

MeSH Terms

Conditions

Pain; Hyperalgesia

Interventions

carbetocin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases

Study Officials

• Michele Curatolo, M.D., Ph.D.

  University Department of Anesthesiology and Pain Therapy, Inselspital Bern, Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 7, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 12, 2015

Record last verified: 2015-02

Locations

CH (1)