Acupuncture for Pain Control After Elective Caesarean Section

University Medicine Greifswald180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

180

Conditions

Postoperative Pain

Interventions

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pain intensity as measured by Numeric Rating Scale 1-10

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

Secondary Outcomes

Total requirement of postoperative analgesics

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

Incidence of complications and adverse effects