Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-30 @ 9:11 PM
Study NCT ID:
NCT06957158
Status:
RECRUITING
Last Update Posted:
2025-06-27
First Post:
2025-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Serum Calcium Levels on Postoperative Pain: A Prospective Observational Study
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': 'D062186', 'term': 'Arterial Pressure'}], 'ancestors': [{'id': 'D001794', 'term': 'Blood Pressure'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Venous blood and arterial blood were collected'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2025-04-26', 'studyFirstSubmitQcDate': '2025-04-26', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of pain NRS score ≥6 within 48 hours after surgery', 'timeFrame': 'From the end of the surgery to 48 hours after surgery', 'description': 'NRS score: pain was assessed using a 10-point NRS (range: 0-10, 0 and 10 indicate no pain and the most extreme pain imaginable, respectively）'}], 'secondaryOutcomes': [{'measure': 'The maximum incisional pain score at 0-12h postoperatively', 'timeFrame': 'From the end of the surgery to 12 hours after surgery', 'description': 'NRS score: pain was assessed using a 10-point NRS (range: 0-10, 0 and 10 indicate no pain and the most extreme pain imaginable, respectively）'}, {'measure': 'The maximum incisional pain score at 12-24h postoperatively', 'timeFrame': 'From 12hours to 24 hours after surgery', 'description': 'NRS score: pain was assessed using a 10-point NRS (range: 0-10, 0 and 10 indicate no pain and the most extreme pain imaginable, respectively）'}, {'measure': 'The maximum incisional pain score at 24-48h postoperatively', 'timeFrame': 'From 24 hours to 48 hours after surgery', 'description': 'NRS score: pain was assessed using a 10-point NRS (range: 0-10, 0 and 10 indicate no pain and the most extreme pain imaginable, respectively）'}, {'measure': 'The maximum visceral pain score at 0-12h postoperatively', 'timeFrame': 'From the end of the surgery to 12 hours after surgery', 'description': 'NRS score: pain was assessed using a 10-point NRS (range: 0-10, 0 and 10 indicate no pain and the most extreme pain imaginable, respectively）'}, {'measure': 'The maximum visceral pain score at 12-24h postoperatively', 'timeFrame': 'From 12 hours to 24 hours after surgery', 'description': 'NRS score: pain was assessed using a 10-point NRS (range: 0-10, 0 and 10 indicate no pain and the most extreme pain imaginable, respectively）'}, {'measure': 'The maximum visceral pain score at 24-48h postoperatively', 'timeFrame': 'From 24 hours to 48 hours after surgery', 'description': 'NRS score: pain was assessed using a 10-point NRS (range: 0-10, 0 and 10 indicate no pain and the most extreme pain imaginable, respectively）'}, {'measure': 'Whether additional analgesia was administered within 48 hours after surgery', 'timeFrame': 'From the end of the surgery to 48 hours after surgery', 'description': 'The proportion of patients who received additional analgesia out of the total patient group'}, {'measure': 'Patient-controlled intravenous analgesia opioid consumption', 'timeFrame': 'From the end of the surgery to 24 hours and 48 hours after surgery', 'description': 'PCIA opioid consumption was assessed by checking the PCIA electronic system'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Serum calcium levels', 'Postoperative pain', 'Ionized calcium levels'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This is a prospective observational study. To investigate the effect of serum calcium levels on postoperative pain in patients undergoing abdominal surgery, and to determine whether changes in serum calcium levels are a risk factor for postoperative pain.', 'detailedDescription': 'This study aimed to measure the total serum calcium and ionized calcium levels both before and after surgery. Additionally, NRS scores were recorded at different time points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent elective abdominal surgery under general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-70 years old\n* American Society of Anesthesiologists Classification I-III\n* Patients undergoing elective abdominal surgery under general anesthesia\n* Patients participate voluntarily and sign an informed consent form\n\nExclusion Criteria:\n\n* Patients with a history of severe disease\n* Patients with chronic preoperative pain and/or long-term analgesic use\n* Patients with hearing disorders or verbal communication difficulties\n* Patients with psychiatric disorders or cognitive dysfunction\n* Patients requiring mechanical ventilation or ICU admission after surgery\n* Patients with a history of substance or alcohol abuse Patients who could not cooperate with the study for any reason'}, 'identificationModule': {'nctId': 'NCT06957158', 'briefTitle': 'The Effect of Serum Calcium Levels on Postoperative Pain: A Prospective Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'The Second Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'The Effect of Serum Calcium Levels on Postoperative Pain in Patients Undergoing Abdominal Surgery: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'Serum calcium levels and pain'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Peripheral venous blood', 'type': 'DIAGNOSTIC_TEST', 'description': 'Peripheral venous blood was collected before and after the surgery to measure the total serum calcium levels.'}, {'name': 'Arterial blood', 'type': 'DIAGNOSTIC_TEST', 'description': 'Arterial blood was collected before anesthesia induction and after removal of the artificial airway to measure ionized calcium levels.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '400010', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guangyou Duan, PhD', 'role': 'CONTACT', 'email': 'duangy@hospital.cqmu.edu.cn', 'phone': '+86 183 2337 6014'}, {'name': 'Guangyou Duan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Second Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Guangyou Duan, PhD', 'role': 'CONTACT', 'email': 'duangy@hospital.cqmu.edu.cn', 'phone': '+86 183 2337 6014'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Five years after the study', 'ipdSharing': 'YES', 'description': 'The individual participant data for this study is available from the sponsor on reasonable request through email'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}