Acupuncture for Pain Control After Elective Caesarean Section

NCT ID: NCT02364167

Last Updated: 2021-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-13
• Study Completion Date: 2018-06-27

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Verum acupuncture

Each patient will receive 16 permanent indwelling acupuncture needles, embedded in adhesive tape, bilaterally in addition to standard postoperative analgesia

Group Type: EXPERIMENTAL

Standard therapy

Intervention Type: DRUG

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

Verum acupuncture

Intervention Type: 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

Each patient will receive 16 adhesive tapes mimicking the indwelling acupuncture needles bilaterally in addition to standard postoperative analgesia

Group Type: PLACEBO_COMPARATOR

Standard therapy

Intervention Type: DRUG

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

Placebo acupuncture

Intervention Type: OTHER

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

Standard therapy

Each patient will receive just standard postoperative analgesia

Group Type: ACTIVE_COMPARATOR

Standard therapy

Intervention Type: DRUG

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

Interventions

Standard therapy

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

Intervention Type: DRUG

Verum acupuncture

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

Intervention Type: DEVICE

Placebo acupuncture

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

Intervention Type: OTHER

Other Intervention Names

Pharmacologic therapy of postoperative pain; Placebo

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Medicine Greifswald

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Taras I Usichenko, MD, PhD

Role: STUDY_DIRECTOR

University Medicine of Greifswald

Locations

Ernst Moritz Arndt University

Greifswald, , Germany

Countries

Germany

References

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. No abstract available.

Reference Type: BACKGROUND

PMID: 24809368 (View on PubMed)

Usichenko TI, Henkel BJ, Klausenitz C, Hesse T, Pierdant G, Cummings M, Hahnenkamp K. Effectiveness of Acupuncture for Pain Control After Cesarean Delivery: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e220517. doi: 10.1001/jamanetworkopen.2022.0517.

Reference Type: DERIVED

PMID: 35226080 (View on PubMed)

Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.

Reference Type: DERIVED

PMID: 32871021 (View on PubMed)

Other Identifiers

AC SC BB 04/15

Identifier Type: -

Identifier Source: org_study_id