NCT02364167

Acupuncture for Pain Control After Elective Caesarean Section

Acupuncture vs. Placebo Acupuncture and vs. Standard Therapy for Pain Control After Elective Caesarean Section - a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: University Medicine Greifswald · Academic / Other
• Sex: Female
• Age: 19 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The study entitled "Acupuncture vs. placebo acupuncture and vs. standard therapy for pain control after elective caesarian section - a randomized controlled trial" aims to investigate whether acupuncture with indwelling fixed needles reduces pain and analgesic requirement as compared to placebo and standard therapy in patients after after elective caesarian section (CS) in the period from January 2015 to May 2016. For that purpose 180 adult patients scheduled to elective elective CS in spinal anesthesia will be recruited according to eligibility criteria. 120 patients will be randomized either to verum or placebo acupuncture, 60 patients will be included in non-randomized "standard therapy" arm. The outcome measures are: postoperative analgesic requirement, pain intensity, incidence of side effects and physiological parameters.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Standard therapy	Standard therapy includes pharmacologic treatment of postoperative pain according to the standards of our University hospital
DEVICE	Verum acupuncture	Verum acupuncture will be performed using indwelling permanent acupuncture needles "New Pyonex" with 1,5 mm length, manufactured by Seirin Corp. Japan
OTHER	Placebo acupuncture	Placebo acupuncture will be performed using the placebo "New Pyonex" adhesive tapes, mimicking the needles, manufactured by Seirin Corp. Japan

Timeline

• Start date: 2015-01-13
• Primary completion: 2018-06-27
• Completion: 2018-06-27
• First posted: 2015-02-16
• Last updated: 2021-01-11

Locations

1 site across 1 country: Germany