Postoperative Pain
Conditions
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.
Interventions
DRUGStandard therapy
Standard therapy includes pharmacologic treatment of postoperative pain according to the standards of our University hospital
DEVICEVerum acupuncture
Verum acupuncture will be performed using indwelling permanent acupuncture needles New Pyonex with 1,5 mm length, manufactured by Seirin Corp. Japan
OTHERPlacebo acupuncture
Placebo acupuncture will be performed using the placebo New Pyonex adhesive tapes, mimicking the needles, manufactured by Seirin Corp. Japan
Sponsors
University Medicine Greifswald
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity as measured by Numeric Rating Scale 1-10 | 4:00 P.M. on the 1st postoperative day |
Secondary
| Measure | 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 |
Countries
Germany
Outcome results
None listed