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Acupuncture for Pain Control After Elective Caesarean Section (ACUSEC)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Standard therapy
Verum acupuncture
Placebo acupuncture
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

19 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ernst Moritz Arndt University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Verum acupuncture

Placebo acupuncture

Standard therapy

Arm Description

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

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

Each patient will receive just standard postoperative analgesia

Outcomes

Primary Outcome Measures

Pain intensity as measured by Numeric Rating Scale 1-10

Secondary Outcome Measures

Total requirement of postoperative analgesics
Incidence of complications and adverse effects

Full Information

First Posted
February 9, 2015
Last Updated
January 8, 2021
Sponsor
University Medicine Greifswald
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1. Study Identification

Unique Protocol Identification Number
NCT02364167
Brief Title
Acupuncture for Pain Control After Elective Caesarean Section
Acronym
ACUSEC
Official Title
Acupuncture vs. Placebo Acupuncture and vs. Standard Therapy for Pain Control After Elective Caesarean Section - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 13, 2015 (Actual)
Primary Completion Date
June 27, 2018 (Actual)
Study Completion Date
June 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medicine Greifswald

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verum acupuncture
Arm Type
Experimental
Arm Description
Each patient will receive 16 permanent indwelling acupuncture needles, embedded in adhesive tape, bilaterally in addition to standard postoperative analgesia
Arm Title
Placebo acupuncture
Arm Type
Placebo Comparator
Arm Description
Each patient will receive 16 adhesive tapes mimicking the indwelling acupuncture needles bilaterally in addition to standard postoperative analgesia
Arm Title
Standard therapy
Arm Type
Active Comparator
Arm Description
Each patient will receive just standard postoperative analgesia
Intervention Type
Drug
Intervention Name(s)
Standard therapy
Other Intervention Name(s)
Pharmacologic therapy of postoperative pain
Intervention Description
Standard therapy includes pharmacologic treatment of postoperative pain according to the standards of our University hospital
Intervention Type
Device
Intervention Name(s)
Verum acupuncture
Intervention Description
Verum acupuncture will be performed using indwelling permanent acupuncture needles "New Pyonex" with 1,5 mm length, manufactured by Seirin Corp. Japan
Intervention Type
Other
Intervention Name(s)
Placebo acupuncture
Other Intervention Name(s)
Placebo
Intervention Description
Placebo acupuncture will be performed using the placebo "New Pyonex" adhesive tapes, mimicking the needles, manufactured by Seirin Corp. Japan
Primary Outcome Measure Information:
Title
Pain intensity as measured by Numeric Rating Scale 1-10
Time Frame
4:00 P.M. on the 1st postoperative day
Secondary Outcome Measure Information:
Title
Total requirement of postoperative analgesics
Time Frame
4:00 P.M. on the 2nd postoperative day
Title
Incidence of complications and adverse effects
Time Frame
4:00 P.M. on the 2nd postoperative day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taras I Usichenko, MD, PhD
Organizational Affiliation
University Medicine of Greifswald
Official's Role
Study Director
Facility Information:
Facility Name
Ernst Moritz Arndt University
City
Greifswald
ZIP/Postal Code
17475
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24809368
Citation
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.
Results Reference
background
PubMed Identifier
35226080
Citation
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. Erratum In: JAMA Netw Open. 2022 Apr 1;5(4):e229622.
Results Reference
derived
PubMed Identifier
32871021
Citation
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.
Results Reference
derived

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Acupuncture for Pain Control After Elective Caesarean Section

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