Acupuncture for Pain Control After Elective Caesarean Section

Phase 2

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Standard therapy; Other: Placebo acupuncture; Device: Verum acupuncture

• Registration Number: NCT02364167
• Lead Sponsor: University Medicine Greifswald

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-13
• Study First Submitted: 2015-02-09
• Study First Submitted QC: 2015-02-13
• Study First Posted: 2015-02-16
• Primary Completion: 2018-06-27
• Study Completion: 2018-06-27
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-08
• Last Update Posted: 2021-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard therapy	Standard therapy	Each patient will receive just standard postoperative analgesia
Placebo acupuncture	Placebo acupuncture	Each patient will receive 16 adhesive tapes mimicking the indwelling acupuncture needles bilaterally in addition to standard postoperative analgesia
Verum acupuncture	Standard therapy	Each patient will receive 16 permanent indwelling acupuncture needles, embedded in adhesive tape, bilaterally in addition to standard postoperative analgesia
Verum acupuncture	Verum acupuncture	Each patient will receive 16 permanent indwelling acupuncture needles, embedded in adhesive tape, bilaterally in addition to standard postoperative analgesia
Placebo acupuncture	Standard therapy	Each patient will receive 16 adhesive tapes mimicking the indwelling acupuncture needles bilaterally in addition to standard postoperative analgesia

Primary Outcome Measures

Name	Time	Method
Pain intensity as measured by Numeric Rating Scale 1-10	4:00 P.M. on the 1st postoperative day

Secondary Outcome Measures

Name	Time	Method
Incidence of complications and adverse effects	4:00 P.M. on the 2nd postoperative day
Total requirement of postoperative analgesics	4:00 P.M. on the 2nd postoperative day

Trial Locations

Locations (1)

Ernst Moritz Arndt University; 🇩🇪 Greifswald, Germany