Acupuncture for Pain Control After Elective Caesarean Section (ACUSEC)

January 8, 2021 updated by: University Medicine Greifswald

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Greifswald, Germany, 17475
        • Ernst Moritz Arndt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Pharmacologic therapy of postoperative pain

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Investigators

  • Study Director: Taras I Usichenko, MD, PhD, University Medicine of Greifswald

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2015

Primary Completion (Actual)

June 27, 2018

Study Completion (Actual)

June 27, 2018

Study Registration Dates

First Submitted

February 9, 2015

First Submitted That Met QC Criteria

February 13, 2015

First Posted (Estimate)

February 16, 2015

Study Record Updates

Last Update Posted (Actual)

January 11, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC SC BB 04/15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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