Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT07134933
Status:
COMPLETED
Last Update Posted:
2025-08-21
First Post:
2025-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Erector Spinae Plane Block on Pain Scores in Unilateral Breast Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010268', 'term': 'Parapsychology'}], 'ancestors': [{'id': 'D001525', 'term': 'Behavioral Sciences'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2019-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2025-08-14', 'studyFirstSubmitQcDate': '2025-08-14', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remifentanil Consumption', 'timeFrame': 'From beginning of anesthesia to finished the surgery', 'description': 'The primary aim of our study was to compare perioperative remifentanil consumption between Group I patients who received a preoperative ESP block and Group II patients who underwent surgery without the block.'}], 'secondaryOutcomes': [{'measure': 'postoperative morphine consumption', 'timeFrame': 'from the end of the surgery to 24 hours of postoperative', 'description': 'After extubation, a patient-controlled analgesia device containing morphine (0.5 mg/ml, 1 mg bolus, 8-minute lockout interval, maximum dose of 6 mg in 1 hour) was installed. The amount of morphine consumed in the postoperative 24 hours was measured.'}, {'measure': 'The VAS scores', 'timeFrame': 'from the end of the surgery to 24 hours of postoperative', 'description': 'Postoperative pain assessment was conducted using the Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates unbearable pain) at rest and during movement at the 5, 15, 30, and 60 minutes, as well as at 2, 4, 6, 8, 16, and 24 hours post-surgery.'}, {'measure': 'patient satisfaction', 'timeFrame': 'at the 24th postoperative hour', 'description': 'a four-point patient satisfaction score (1: poor, 2: fair, 3: good, 4: excellent) were evaluated by an anesthetist who was unaware of the study groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Erector spinae plane block', 'patient satisfaction', 'breast surgery', 'postoperative analgesia'], 'conditions': ['Erector Spinae Plane Block']}, 'referencesModule': {'references': [{'pmid': '28564673', 'type': 'BACKGROUND', 'citation': 'Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.'}]}, 'descriptionModule': {'briefSummary': 'The high incidence of breast cancer is increasing the need for oncologic breast surgery. The optimal acute postoperative pain management after breast surgery is not yet clear. The erector spinae plane block (ESPB) is a newer and may be potentially safer alternative other regional analgesia techniques. We will investigate the effectiveness of ESP for managing acute pain after breast cancer surgery. Patients will randomise to receive either ESP block (Group1)or no ESP block (Group II). The primary outcome is postoperative pain scores used Visual Analog Scale (VAS), and the secondary outcomes include intraoperative opioid consumption postoperative total opioid consumption and patient satisfaction.', 'detailedDescription': 'Anesthesia induction was achieved with propofol (2-3 mg kg-1), fentanyl (2 mcg kg-1), and rocuronium (0.6 mg kg-1). Anesthesia was maintained with Total intravenous anesthesia (TIVA) used remifentanil (0.25-0.5 mcg kg-1 min-1) and propofol (150 mcg kg-1 min-1). During maintenance, a fresh gas flow of 3 L with a mixture of 50% oxygen and 50% air was used. The BIS value was kept between 30-50.\n\nPatients were divided into two groups according to a computer-based simple randomization method. Those who received a preoperative ESP block at the T4 vertebra level under ultrasound guidance were designated as Group I, while those who underwent surgery without the block were designated as Group II.\n\nThe ESP block was performed unilaterally in the direction of the surgery by the same anesthetist. Blocks were performed using an Esaote ultrasound device (Esaote My Lab 6 US machine, Florence, Italy), a multifrequency convex probe (1-8 MHz), and a 22-gauge, 50 mm facet needle (B. Braun Sonoplex, Melsungen, Germany) The block needle was placed at the level of the T4 spinal process using the in-plane approach, approximately 3 cm lateral to the T4 spinous process in the parasagittal plane. After visualizing the transverse process with the in-plane approach, the 50 mm facet needle (B. Braun Sonoplex, Melsungen, Germany) was inserted through the skin, and a test dose of 1 ml of 0.9% NaCl was injected between the fascia of the trapezius, rhomboid, and erector spinae muscles and the transverse vertebral process to confirm the location. A total of 20 ml of 0.5% bupivacaine was used as a local anesthetic. The cranial and caudal spread of the local anesthetic was monitored.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Since patients were required to undergo breast surgery, only female gender was included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II\n* the patients who undergone unilateral surgery due to breast tumors\n\nExclusion Criteria:\n\n* obesity (body mass index\\> 35 kg/m²)\n* infection at the needle entry site,\n* known allergy history to the medications to be used,\n* coagulopathy\n* a history of opioid use'}, 'identificationModule': {'nctId': 'NCT07134933', 'briefTitle': 'The Effects of Erector Spinae Plane Block on Pain Scores in Unilateral Breast Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': 'The Effects of Erector Spinae Plane Block on Pain Scores and Patient Experience in Unilateral Breast Cancer Surgery: A Prospective, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'ESP Block'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I', 'description': 'The group with ESP block was defined as Group 1. The ESP block was performed unilaterally in the direction of the surgery.', 'interventionNames': ['Procedure: ESP (erector spinae plane)block']}, {'type': 'NO_INTERVENTION', 'label': 'Group II', 'description': 'The group without ESP block was defined as Group II.'}], 'interventions': [{'name': 'ESP (erector spinae plane)block', 'type': 'PROCEDURE', 'description': 'The ESP block was performed unilaterally in the direction of the surgery by the same anesthetist. Blocks were performed using an Esaote ultrasound device (Esaote My Lab 6 US machine, Florence, Italy), a multifrequency convex probe (1-8 MHz), and a 22-gauge, 50 mm facet needle (B. Braun Sonoplex, Melsungen, Germany). The block needle was placed at the level of the T4 spinal process using the in-plane approach, approximately 3 cm lateral to the T4 spinous process in the parasagittal plane. After visualizing the transverse process with the in-plane approach, the 50 mm facet needle (B. Braun Sonoplex, Melsungen, Germany) was inserted through the skin, and a test dose of 1 ml of 0.9% NaCl was injected between the fascia of the trapezius, rhomboid, and erector spinae muscles and the transverse vertebral process to confirm the location. A total of 20 ml of 0.5% bupivacaine was used as a local anesthetic.', 'armGroupLabels': ['Group I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44100', 'city': 'Malatya', 'country': 'Turkey (Türkiye)', 'facility': 'İnonu University Medicine Faculty Turgut ozal Medical Center', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}], 'overallOfficials': [{'name': 'Mukadder Sanli, Associate Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Inonu University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We do not want our data to be used by others.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Mukadder Sanli', 'investigatorAffiliation': 'Inonu University'}}}}