Clinical trial NCT02364167: Acupuncture for Pain Control After Elective Caesarean Section
Official title: Acupuncture vs. Placebo Acupuncture and vs. Standard Therapy for Pain Control After Elective Caesarean Section - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postoperative Pain
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2015-02-16
Enrollment: 180
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain intensity as measured by Numeric Rating Scale 1-10
timeFrame: 4:00 P.M. on the 1st postoperative day
Secondary outcomes:
measure: Total requirement of postoperative analgesics
timeFrame: 4:00 P.M. on the 2nd postoperative day
measure: Incidence of complications and adverse effects
timeFrame: 4:00 P.M. on the 2nd postoperative day
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Ernst Moritz Arndt University
Study officials:
affiliation: University Medicine of Greifswald
name: Taras I Usichenko, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.