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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01918475
Other study ID # 140/12
Secondary ID 2013DR1021
Status Completed
Phase N/A
First received August 6, 2013
Last updated February 11, 2015
Start date July 2013
Est. completion date December 2014

Study information

Verified date February 2015
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority Switzerland: EthikkommissionSwitzerland: Swissmedic
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
Carbetocin
Carbetocin 0.1 mg single dose is intravenously administered
Placebo
1ml of NaCl 0.9% is administered intravenously

Locations

Country Name City State
Switzerland University Department of Anesthesiology and Pain Therapy, Bern University Hospital Bern

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in intramuscular electrical pain threshold compared to baseline 10, 60 and 120 minutes after carbeoticin administration No
Secondary Capsaicin-induced area of hyperalgesia and allodynia 10, 60 and 120 minutes after carbeoticin administration No
Secondary Nociceptive withdrawal reflex thresholds of the foot 10, 60 and 120 minutes after carbeoticin administration No
Secondary Single cutaneous electrical pain thresholds 10, 60 and 120 minutes after carbeoticin administration No
Secondary Repeated cutaneous electrical pain thresholds 10, 60 and 120 minutes after carbeoticin administration No
Secondary Single intramuscular electrical pain threshold 10, 60 and 120 minutes after carbeoticin administration No
Secondary Heat pain detection threshold 10, 60 and 120 minutes after carbeoticin administration No
Secondary Heat pain tolerance threshold 10, 60 and 120 minutes after carbetocin administration No
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