Acupuncture for Pain Control After Elective Caesarean Section

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Standard therapy
* Device: Verum acupuncture
* Other: Placebo acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum acupuncture<br>Each patient will receive 16 permanent indwelling acupuncture needles, embedded in adhesive tape, bilaterally in addition to standard postoperative analgesia | Drug: Standard therapy<br>* Standard therapy includes pharmacologic treatment of postoperative pain according to the standards of our University hospital<br>* Other names: Pharmacologic therapy of postoperative pain;Device: Verum acupuncture<br>* Verum acupuncture will be performed using indwelling permanent acupuncture needles New Pyonex with 1,5 mm length, manufactured by Seirin Corp. Japan<br>|
| Placebo Comparator: Placebo acupuncture<br>Each patient will receive 16 adhesive tapes mimicking the indwelling acupuncture needles bilaterally in addition to standard postoperative analgesia | Drug: Standard therapy<br>* Standard therapy includes pharmacologic treatment of postoperative pain according to the standards of our University hospital<br>* Other names: Pharmacologic therapy of postoperative pain;Other: Placebo acupuncture<br>* Placebo acupuncture will be performed using the placebo New Pyonex adhesive tapes, mimicking the needles, manufactured by Seirin Corp. Japan<br>* Other names: Placebo;|
| Active Comparator: Standard therapy<br>Each patient will receive just standard postoperative analgesia | Drug: Standard therapy<br>* Standard therapy includes pharmacologic treatment of postoperative pain according to the standards of our University hospital<br>* Other names: Pharmacologic therapy of postoperative pain;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity as measured by Numeric Rating Scale 1-10 |  | 4:00 P.M. on the 1st postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |