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NCT Number: NCT02364167

Acupuncture for Pain Control After Elective Caesarean Section

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

19 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ernst Moritz Arndt University

Greifswald, 17475, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard therapy

Drug

Standard therapy includes pharmacologic treatment of postoperative pain according to the standards of our University hospital

Other names: Pharmacologic therapy of postoperative pain

Verum acupuncture

Device

Verum acupuncture will be performed using indwelling permanent acupuncture needles "New Pyonex" with 1,5 mm length, manufactured by Seirin Corp. Japan

Placebo Acupuncture

Other

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

Other names: Placebo

Primary outcomes

  1. Pain intensity as measured by Numeric Rating Scale 1-10

    Time frame: 4:00 P.M. on the 1st postoperative day

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Registry information

Official study title

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

Acronym: ACUSEC

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 16, 2015
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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