Acupuncture for Pain Control After Elective Caesarean Section

NCT02364167 | Completed Phase 2

• 1 other identifier: AC SC BB 04/15
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (2)

• Total requirement of postoperative analgesics

  4:00 P.M. on the 2nd postoperative day

• Incidence of complications and adverse effects

  4:00 P.M. on the 2nd postoperative day

Study Arms (3)

Verum acupuncture

EXPERIMENTAL

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

Drug: Standard therapy; Device: Verum acupuncture

Placebo acupuncture

PLACEBO COMPARATOR

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

Drug: Standard therapy; Other: Placebo acupuncture

Standard therapy

ACTIVE COMPARATOR

Each patient will receive just standard postoperative analgesia

Drug: Standard therapy

Interventions

Standard therapy DRUG

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

Also known as: Pharmacologic therapy of postoperative pain

Placebo acupuncture; Standard therapy; Verum acupuncture

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

Verum acupuncture

Placebo acupuncture OTHER

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

Also known as: Placebo

Placebo acupuncture

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

Ernst Moritz Arndt University

Greifswald, 17475, Germany

Location

Related Publications (3)

• 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.

  PMID: 24809368 BACKGROUND

• 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.

  PMID: 35226080 DERIVED

• 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.

  PMID: 32871021 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Taras I Usichenko, MD, PhD

  University Medicine of Greifswald

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 16, 2015
• Study Start: January 13, 2015
• Primary Completion: June 27, 2018
• Study Completion: June 27, 2018
• Last Updated: January 11, 2021

Record last verified: 2021-01

Locations

DE (1)