Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:50 PM
Study NCT ID:
NCT03711994
Status:
TERMINATED
Last Update Posted:
2022-06-02
First Post:
2016-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cold Therapy for Pain Control Following 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Unable to get product at this time', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-01', 'studyFirstSubmitDate': '2016-01-25', 'studyFirstSubmitQcDate': '2018-10-16', 'lastUpdatePostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post Operative Pain', 'timeFrame': '48 hours after surgery', 'description': 'Will Utilize Visual Analog Scales to evaluate and measure pain in the post operative period.'}], 'secondaryOutcomes': [{'measure': 'Narcotic Utilization', 'timeFrame': '48 hours after surgrey', 'description': 'Evaluate total narcotics used during time frame'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Post Operative Pain']}, 'referencesModule': {'references': [{'pmid': '7433601', 'type': 'BACKGROUND', 'citation': 'Placek PJ, Taffel SM. Trends in cesarean section rates for the United States, 1970--78. Public Health Rep. 1980 Nov-Dec;95(6):540-8.'}, {'pmid': '6869638', 'type': 'BACKGROUND', 'citation': 'Placek PJ, Taffel S, Moien M. Cesarean section delivery rates: United States, 1981. Am J Public Health. 1983 Aug;73(8):861-2. doi: 10.2105/ajph.73.8.861.'}, {'pmid': '2296123', 'type': 'BACKGROUND', 'citation': 'Stafford RS. Alternative strategies for controlling rising cesarean section rates. JAMA. 1990 Feb 2;263(5):683-7.'}, {'pmid': '1442907', 'type': 'BACKGROUND', 'citation': 'Amin-Hanjani S, Corcoran J, Chatwani A. Cold therapy in the management of postoperative cesarean section pain. Am J Obstet Gynecol. 1992 Jul;167(1):108-9. doi: 10.1016/s0002-9378(11)91638-x.'}, {'pmid': '16432641', 'type': 'BACKGROUND', 'citation': 'Koc M, Tez M, Yoldas O, Dizen H, Gocmen E. Cooling for the reduction of postoperative pain: prospective randomized study. Hernia. 2006 Apr;10(2):184-6. doi: 10.1007/s10029-005-0062-2. Epub 2006 Jan 24.'}, {'pmid': '17162178', 'type': 'BACKGROUND', 'citation': 'Kullenberg B, Ylipaa S, Soderlund K, Resch S. Postoperative cryotherapy after total knee arthroplasty: a prospective study of 86 patients. J Arthroplasty. 2006 Dec;21(8):1175-9. doi: 10.1016/j.arth.2006.02.159.'}, {'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': 'Cold Therapy has been used for a variety of procedures and has been studied in several but not recently studied for reducing postop pain following Caesarean Sections. The hypothesis is that Cold Therapy will reduce postop pain and increase patients mobility and improve care of her newborn.', 'detailedDescription': "Cesarean Section (C/S) is one of the most commonly performed surgeries in many parts of the world. In the United States the C/S rate in 1965 was 4.5% and increased to 30.5% in 2010. While the number of C/S has increased, pain management has primarily been via epidural, spinal, local and general anesthesia and narcotic medication for the immediate postpartum period (pp). This has lead to an increase in associated cost and problems with pain management. Limited studies have been performed to evaluate cold compresses on pain relief in the immediate pp and there potential to reduce cost. Cold Therapy (CT) is most often utilized in orthopedics, sports medicine, and in general surgery. CT has been used to improve range of motion (rom) and reduce pain medication utilization. We surmise CT may be useful in decreasing narcotic utilization after C/S, as well as improve mobility and allow for improved care of the newborn. This is significant as Erlanger Baroness Hospital (EBH) is becoming Baby Friendly (BF). This is a National Initiative for Children's Healthcare Quality (NICHQ) which desires having babies rooming in with their mothers and increasing breastfeeding rates. The goal of this study is to evaluate a newer sterile delivery system for decreasing pp pain via CT. This will be done as a Randomized Controlled Trial (RCT)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '43 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* greater than 36 weeks gestation\n* primary C/S with Epidural for labor problems or breech presentation\n* Repeat C/S with spinal\n\nExclusion Criteria:\n\n* less than 36.0 week gestations\n* vertical skin incisions\n* classical or vertical hysterotomy incisions\n* failed vaginal births after C/S (VBAC)\n* past history of drug or alcohol abuse\n* positive drug screens unless medical prescribed drugs\n* general anesthesia\n* Caesarean Hysterectomy\n* primary C/S with spinal anesthesia'}, 'identificationModule': {'nctId': 'NCT03711994', 'briefTitle': 'Cold Therapy for Pain Control Following Caesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'University of Tennessee'}, 'officialTitle': 'Cold Therapy for Pain Control Following Caesarean Section at Erlanger Baroness Hospital', 'orgStudyIdInfo': {'id': '14-133'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Repeat C/S Control', 'description': 'Repeat C/S done with spinal without Alkantis ice pack but with similar size dressings.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Repeat C/S Treatment', 'description': 'Repeat C/S done with spinal with Alkantis ice pack.', 'interventionNames': ['Other: Alkantis']}, {'type': 'NO_INTERVENTION', 'label': 'Primary C/S - Control', 'description': 'Primary C/S done with Epidural without Alkantis ice pack but with similar size dressings.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Primary C/S Treatment', 'description': 'Primary C/S done with Epidural with Alkantis ice pack.', 'interventionNames': ['Other: Alkantis']}], 'interventions': [{'name': 'Alkantis', 'type': 'OTHER', 'description': 'cold therapy pack placed on the wound post operatively', 'armGroupLabels': ['Primary C/S Treatment', 'Repeat C/S Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37403', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Erlanger Hospital', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}], 'overallOfficials': [{'name': 'William E Gist, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tennessee College of Medicine- Chattanooga'}, {'name': 'Kreg Jonson, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Tennessee College of Medicine- Chattanooga'}, {'name': 'Mandi Raper', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Tennessee College of Medicine- Chattanooga'}, {'name': 'Erin Tannous, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Tennessee College of Medicine- Chattanooga'}, {'name': 'Olkayoude Akinlaja, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Tennessee College of Medicine- Chattanooga'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tennessee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}