Acupuncture for Pain Control After Elective Caesarean Section

Postoperative Pain Clinical Trial

— ACUSEC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364167
• Other study ID #: AC SC BB 04/15
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 13, 2015
• Est. completion date: June 27, 2018

Study information

• Verified date: January 2021
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 27, 2018
• Est. primary completion date: June 27, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients with an American Society of Anaesthesiologists physical status of I to III scheduled for elective caesarean section in spinal anaesthesia

• Surgery time does not exceed 60 minutes

• Patients without previous opioid and psychotropic medication

• Patients ranged 19-45 years old

• Patients who have given written informed consent

Exclusion Criteria:

• Recidivist alcoholics

• Local skin infection at the sites of acupuncture

• Age < 19 and > 45 years

• Switching to general anaesthesia in cases where spinal anaesthesia fails

• Surgery time more than 60 minutes

• Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines except for short hypotension after induction of spinal anaesthesia )

• Patients who consumed opioid medication at least 6 months before surgery

• Patients who are unable to understand the consent form and fill in the study questionnaire

• History of psychiatric disease

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Germany	Ernst Moritz Arndt University	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Usichenko TI. Acupuncture as part of multimodal analgesia after caesarean section. Acupunct Med. 2014 Jun;32(3):297-8. doi: 10.1136/acupmed-2014-010584. Epub 2014 May 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity as measured by Numeric Rating Scale 1-10		4:00 P.M. on the 1st postoperative day
Secondary	Total requirement of postoperative analgesics		4:00 P.M. on the 2nd postoperative day
Secondary	Incidence of complications and adverse effects		4:00 P.M. on the 2nd postoperative day