Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-04 @ 1:21 AM
Study NCT ID:
NCT05877157
Status:
RECRUITING
Last Update Posted:
2024-12-24
First Post:
2023-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain AND Opioids After Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-18', 'studyFirstSubmitDate': '2023-04-06', 'studyFirstSubmitQcDate': '2023-05-23', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient reported Opioid use post surgery', 'timeFrame': '3 months', 'description': 'Patient reported use of opioids post surgery'}], 'secondaryOutcomes': [{'measure': 'Opioid use', 'timeFrame': 'From recruitment to 1 year post surgery', 'description': 'Patient reported use of opioids pre-op and opioids used during surgery and prescribed post surgery'}, {'measure': 'Patient reported incidence of pain pre-op and post surgery using BPI-SF', 'timeFrame': 'From recruitment to 1 year post surgery', 'description': 'Patient reported incidence of pain pre-op and post surgery using BPI-SF'}, {'measure': 'Patient reported incidence of pain pre-op and post surgery using DN2', 'timeFrame': 'From recruitment to 1 year post surgery', 'description': 'Patient reported incidence of pain pre-op and post surgery using DN2'}, {'measure': 'Surgical complications', 'timeFrame': 'During surgery', 'description': 'Recording of surgical complications during surgery'}, {'measure': 'Participant reported quality of life EQ5D-5L', 'timeFrame': 'From recruitment to 1 year post surgery', 'description': 'EQ5D-5L'}, {'measure': 'Participant reported quality of life BPI-SF', 'timeFrame': 'From recruitment to 1 year post surgery', 'description': 'BPI-SF'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use', 'Pain, Chronic', 'Pain, Postoperative', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to document the perioperative opioid use and its safety in the UK and countries in Europe and to describe its association with surgical complications, persistent pain and quality of life. In an international, prospective, observational cohort study, data about the perioperative pain management will be collected in all eligible hospitalised adult patients who undergo surgery in a designated "study week" in as many hospitals as possible in Europe. Baseline data will be collected, and participants followed up at one week, and at three and twelve months post-operatively. The primary outcome will be opioid use at three months after surgery. Secondary outcomes will include opioid use during the preoperative month (preoperative use), during surgery and up to one week after surgery (or discharge, whichever is earlier), and up to the end of the postoperative year. Additional secondary outcomes are the incidence of preoperative pain, persistent pain with/without the presence of neuropathic components, quality of life and surgical complications. The potential association between opioid use and pain outcomes will be investigated. This study could help to develop strategies to improve quality of care, through pain management, for patients undergoing surgery.', 'detailedDescription': 'PANDOS is an international, prospective, observational cohort study. In a one week period (the designated "study week"), data will be collected in all eligible hospitalised adult patients who undergo surgery in as many hospitals as possible in the UK and Europe. Participants will be followed up for 12 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All eligible patients undergoing surgery at the hospital during the designated study week', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hospitalised adult patients (18 years and older) undergoing any inpatient surgery (elective or emergency) during the designated study week where an anaesthetist is involved (general anaesthetic, sedation, local anaesthetic).\n\nAble to understand and has capacity to give written informed consent\n\nExclusion Criteria:\n\n* American Society of Anaesthesiologists (ASA) grade V or VI\n* Refusal to participate.\n* Lack of comprehension of validated questionnaires or inability to complete the follow-up for any reason.\n* Lack of capacity to give written informed consent'}, 'identificationModule': {'nctId': 'NCT05877157', 'acronym': 'PANDOS', 'briefTitle': 'Pain AND Opioids After Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Aberdeen'}, 'officialTitle': 'Pain and Opioids After Surgery (PANDOS) Study', 'orgStudyIdInfo': {'id': '2-082-21'}}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Zagreb', 'state': 'Vinogradska 29', 'status': 'NOT_YET_RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Tomislav Radocaj', 'role': 'CONTACT', 'email': 'tomislav.radocaj@kbcsm.hr', 'phone': '+38591 1262 586'}], 'facility': 'Department of Anaesthesiology Sestre Milosrdnice, University Hospital Center', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Aberdeen', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'NHS Grampian', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'city': 'London', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United Kingdom', 'facility': 'University College London Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Nottingham', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United Kingdom', 'facility': 'Kings Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'centralContacts': [{'name': 'Patrice Forget', 'role': 'CONTACT', 'email': 'patrice.forget@abdn.ac.uk', 'phone': '01224437285'}, {'name': 'Holly R Keir, PhD', 'role': 'CONTACT', 'email': 'PANDOS@abdn.ac.uk'}], 'overallOfficials': [{'name': 'Patrice Forget', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aberdeen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aberdeen', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Society of Anaesthesiology and Intensive Care', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}