Acupuncture for Pain Control After Elective Caesarean Section (ACUSEC)

University Medicine Greifswald

Status and phase: Completed; Phase 3; Phase 2

Conditions: Postoperative Pain

Treatments: Other: Placebo acupuncture; Drug: Standard therapy; Device: Verum acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02364167

AC SC BB 04/15

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: Female

Ages: 19 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 3 patient groups, including a placebo group

Verum acupuncture

Experimental group

Description:

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

Treatment:

Device: Verum acupuncture

Drug: Standard therapy

Placebo acupuncture

Placebo Comparator group

Description:

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

Treatment:

Drug: Standard therapy

Other: Placebo acupuncture

Standard therapy

Active Comparator group

Description:

Each patient will receive just standard postoperative analgesia

Treatment:

Drug: Standard therapy