Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-02 @ 3:45 AM
Study NCT ID:
NCT04068766
Status:
UNKNOWN
Last Update Posted:
2019-08-28
First Post:
2019-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Paracervical Block in Laparoscopic Myomectomy: a Randomized Controlled Trial (PALM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000773', 'term': 'Anesthesia, Obstetrical'}, {'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-23', 'studyFirstSubmitDate': '2019-08-23', 'studyFirstSubmitQcDate': '2019-08-23', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': 'at 6-hour after surgery', 'description': 'The scale was presented as a 10-cm line with verbal descriptors ranging from "no pain" to "worst imaginable pain".'}], 'secondaryOutcomes': [{'measure': 'Frequency of pills/injections requested', 'timeFrame': 'Within 24-hour after surgery', 'description': 'Narcotic and non-narcotic use were measured by number of pills/injections requested within 24-hour after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uterine Fibroid']}, 'descriptionModule': {'briefSummary': 'It remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in laparoscopic myomectomy (LM), because convincing conclusions are difficult to draw because of the heterogeneous and contradictory nature of the literature. Therefore, the aim of this study was to evaluate the efficacy of paracervical blocks using with 0.5% bupivacaine prior to LM for benign gynecologic conditions on postoperative pain relief.', 'detailedDescription': 'However, no study investigating the efficacy of paracervical block in laparoscopic myomectomy on postoperative pain was conducted, to date. Therefore, the goal of this study is to evaluate whether patients who receive a paracervical block of 5% bupivacaine with epinephrine at the time of laparoscopic myomectomy would have lower postoperative pain, with less consumption of rescue analgesics than patients who receive a paracervical block of normal saline.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Uterine myoma\n* American Society of Anesthesiologists physical status (ASAPS) classification I-II\n* The absence of pregnancy at the time of surgery.\n\nExclusion Criteria:\n\n* history of cervical surgery such as conization or cerclage\n* inability to perform the paracervical block due to anatomical abnormalities (i.e., very atrophic or small cervix)\n* allergy to bupivacaine, planned concomitant surgical procedures involving extensive additional tissue manipulation such as pelvic lymph node dissection\n* any concomitant surgery of pelvic floor repair (uterosacral ligament suspension or sacrocolpopexy) or vaginal procedure (anterior or posterior colporrhaphy or mid-urethral slings)\n* previously taking opioids for chronic pain\n* inability to accurately express their pain'}, 'identificationModule': {'nctId': 'NCT04068766', 'acronym': 'PALM', 'briefTitle': 'Efficacy of Paracervical Block in Laparoscopic Myomectomy: a Randomized Controlled Trial (PALM)', 'organization': {'class': 'OTHER', 'fullName': 'Kangbuk Samsung Hospital'}, 'officialTitle': 'Efficacy of Paracervical Block in Laparoscopic Myomectomy: a Randomized Controlled Trial (PALM)', 'orgStudyIdInfo': {'id': 'KBSMC 2019-08-024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paracervical block with 5% bupivacaine', 'description': "The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.", 'interventionNames': ['Device: Paracervical block', 'Drug: 5% bupivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Paracervical block with normal saline', 'description': 'ck with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.', 'interventionNames': ['Device: Paracervical block', 'Drug: Normal saline']}], 'interventions': [{'name': 'Paracervical block', 'type': 'DEVICE', 'otherNames': ['Experimental arm', 'Control arm'], 'description': "The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine or normal saline was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.", 'armGroupLabels': ['Paracervical block with 5% bupivacaine', 'Paracervical block with normal saline']}, {'name': '5% bupivacaine', 'type': 'DRUG', 'otherNames': ['Experimental arm'], 'description': "The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.", 'armGroupLabels': ['Paracervical block with 5% bupivacaine']}, {'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['Control arm'], 'description': "The paracervical injection with 10 mL of normal saline was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.", 'armGroupLabels': ['Paracervical block with normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03181', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Taejong Song', 'role': 'CONTACT', 'email': 'taejong.song@gmail.com', 'phone': '1040358405'}], 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Wŏnju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'San-Hui Lee, M.D.', 'role': 'CONTACT', 'email': 'saniarami@gmail.com', 'phone': '+821040358405'}, {'name': 'San-Hui Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}], 'centralContacts': [{'name': 'Taejong Song, MD PhD', 'role': 'CONTACT', 'email': 'taejong.song@gmail.com', 'phone': '+821040358405'}], 'overallOfficials': [{'name': 'Taejong Song', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kangbuk Samsung Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kangbuk Samsung Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Taejong Song', 'investigatorAffiliation': 'Kangbuk Samsung Hospital'}}}}