Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-24 @ 12:25 AM
Study NCT ID:
NCT02364167
Status:
COMPLETED
Last Update Posted:
2021-01-11
First Post:
2015-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture for Pain Control After Elective Caesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-08', 'studyFirstSubmitDate': '2015-02-09', 'studyFirstSubmitQcDate': '2015-02-13', 'lastUpdatePostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity as measured by Numeric Rating Scale 1-10', 'timeFrame': '4:00 P.M. on the 1st postoperative day'}], 'secondaryOutcomes': [{'measure': 'Total requirement of postoperative analgesics', 'timeFrame': '4:00 P.M. on the 2nd postoperative day'}, {'measure': 'Incidence of complications and adverse effects', 'timeFrame': '4:00 P.M. on the 2nd postoperative day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '24809368', 'type': 'BACKGROUND', 'citation': 'Usichenko TI. Acupuncture as part of multimodal analgesia after caesarean section. Acupunct Med. 2014 Jun;32(3):297-8. doi: 10.1136/acupmed-2014-010584. Epub 2014 May 7. No abstract available.'}, {'pmid': '35226080', 'type': 'DERIVED', 'citation': 'Usichenko TI, Henkel BJ, Klausenitz C, Hesse T, Pierdant G, Cummings M, Hahnenkamp K. Effectiveness of Acupuncture for Pain Control After Cesarean Delivery: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e220517. doi: 10.1001/jamanetworkopen.2022.0517.'}, {'pmid': '32871021', 'type': 'DERIVED', 'citation': 'Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nFor 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with an American Society of Anaesthesiologists physical status of I to III scheduled for elective caesarean section in spinal anaesthesia\n* Surgery time does not exceed 60 minutes\n* Patients without previous opioid and psychotropic medication\n* Patients ranged 19-45 years old\n* Patients who have given written informed consent\n\nExclusion Criteria:\n\n* Recidivist alcoholics\n* Local skin infection at the sites of acupuncture\n* Age \\< 19 and \\> 45 years\n* Switching to general anaesthesia in cases where spinal anaesthesia fails\n* Surgery time more than 60 minutes\n* 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 )\n* Patients who consumed opioid medication at least 6 months before surgery\n* Patients who are unable to understand the consent form and fill in the study questionnaire\n* History of psychiatric disease'}, 'identificationModule': {'nctId': 'NCT02364167', 'acronym': 'ACUSEC', 'briefTitle': 'Acupuncture for Pain Control After Elective Caesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'University Medicine Greifswald'}, 'officialTitle': 'Acupuncture vs. Placebo Acupuncture and vs. Standard Therapy for Pain Control After Elective Caesarean Section - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AC SC BB 04/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Verum acupuncture', 'description': 'Each patient will receive 16 permanent indwelling acupuncture needles, embedded in adhesive tape, bilaterally in addition to standard postoperative analgesia', 'interventionNames': ['Drug: Standard therapy', 'Device: Verum acupuncture']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo acupuncture', 'description': 'Each patient will receive 16 adhesive tapes mimicking the indwelling acupuncture needles bilaterally in addition to standard postoperative analgesia', 'interventionNames': ['Drug: Standard therapy', 'Other: Placebo acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard therapy', 'description': 'Each patient will receive just standard postoperative analgesia', 'interventionNames': ['Drug: Standard therapy']}], 'interventions': [{'name': 'Standard therapy', 'type': 'DRUG', 'otherNames': ['Pharmacologic therapy of postoperative pain'], 'description': 'Standard therapy includes pharmacologic treatment of postoperative pain according to the standards of our University hospital', 'armGroupLabels': ['Placebo acupuncture', 'Standard therapy', 'Verum acupuncture']}, {'name': 'Verum acupuncture', 'type': 'DEVICE', 'description': 'Verum acupuncture will be performed using indwelling permanent acupuncture needles "New Pyonex" with 1,5 mm length, manufactured by Seirin Corp. Japan', 'armGroupLabels': ['Verum acupuncture']}, {'name': 'Placebo acupuncture', 'type': 'OTHER', 'otherNames': ['Placebo'], 'description': 'Placebo acupuncture will be performed using the placebo "New Pyonex" adhesive tapes, mimicking the needles, manufactured by Seirin Corp. Japan', 'armGroupLabels': ['Placebo acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17475', 'city': 'Greifswald', 'country': 'Germany', 'facility': 'Ernst Moritz Arndt University', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}], 'overallOfficials': [{'name': 'Taras I Usichenko, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Medicine of Greifswald'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medicine Greifswald', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}