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Acupuncture for Pain Control After Elective Caesarean Section (ACUSEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02364167
Recruitment Status : Completed
First Posted : February 16, 2015
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
University Medicine Greifswald

Brief 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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Standard therapy Device: Verum acupuncture Other: Placebo acupuncture Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture vs. Placebo Acupuncture and vs. Standard Therapy for Pain Control After Elective Caesarean Section - a Randomized Controlled Trial
Actual Study Start Date : January 13, 2015
Actual Primary Completion Date : June 27, 2018
Actual Study Completion Date : June 27, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Verum acupuncture
Each patient will receive 16 permanent indwelling acupuncture needles, embedded in adhesive tape, bilaterally in addition to standard postoperative analgesia
Drug: Standard therapy
Standard therapy includes pharmacologic treatment of postoperative pain according to the standards of our University hospital
Other Name: Pharmacologic therapy of postoperative pain

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

Placebo Comparator: Placebo acupuncture
Each patient will receive 16 adhesive tapes mimicking the indwelling acupuncture needles bilaterally in addition to standard postoperative analgesia
Drug: Standard therapy
Standard therapy includes pharmacologic treatment of postoperative pain according to the standards of our University hospital
Other Name: Pharmacologic therapy of postoperative pain

Other: Placebo acupuncture
Placebo acupuncture will be performed using the placebo "New Pyonex" adhesive tapes, mimicking the needles, manufactured by Seirin Corp. Japan
Other Name: Placebo

Active Comparator: Standard therapy
Each patient will receive just standard postoperative analgesia
Drug: Standard therapy
Standard therapy includes pharmacologic treatment of postoperative pain according to the standards of our University hospital
Other Name: Pharmacologic therapy of postoperative pain




Primary Outcome Measures :
  1. Pain intensity as measured by Numeric Rating Scale 1-10 [ Time Frame: 4:00 P.M. on the 1st postoperative day ]

Secondary Outcome Measures :
  1. Total requirement of postoperative analgesics [ Time Frame: 4:00 P.M. on the 2nd postoperative day ]
  2. Incidence of complications and adverse effects [ Time Frame: 4:00 P.M. on the 2nd postoperative day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02364167


Locations
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Germany
Ernst Moritz Arndt University
Greifswald, Germany, 17475
Sponsors and Collaborators
University Medicine Greifswald
Investigators
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Study Director: Taras I Usichenko, MD, PhD University Medicine of Greifswald
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT02364167    
Other Study ID Numbers: AC SC BB 04/15
First Posted: February 16, 2015    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations