Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-01-02 @ 4:13 PM
Study NCT ID:
NCT00454259
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2007-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fentanyl Ultra Low Doses Effects on the Nociceptive Threshold
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': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-02', 'studyFirstSubmitDate': '2007-03-29', 'studyFirstSubmitQcDate': '2007-03-29', 'lastUpdatePostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nociceptive threshold evaluated with sternal electronical Von Frey mechanical stimulation. The stimulation will increase until the volunteer presses a trigger when the stimulation becomes painful.', 'timeFrame': '5 min after injection, and every 15 min during 1 hour'}], 'secondaryOutcomes': [{'measure': 'Non invasive blood pressure (SBP, DBP), heart rate, respiratory rate, pulse oxymetry and cognitive functions evaluation (sedation score).', 'timeFrame': 'all along the experimentation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Postoperative Hyperalgesia', 'Human volunteer', 'Fentanyl', 'Randomized Controlled Trial', 'Pain chronicisation', 'Predictive test'], 'conditions': ['Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '16129988', 'type': 'BACKGROUND', 'citation': 'Hsu YW, Somma J, Hung YC, Tsai PS, Yang CH, Chen CC. Predicting postoperative pain by preoperative pressure pain assessment. Anesthesiology. 2005 Sep;103(3):613-8. doi: 10.1097/00000542-200509000-00026.'}, {'pmid': '14527702', 'type': 'BACKGROUND', 'citation': 'Kalkman JC, Visser K, Moen J, Bonsel JG, Grobbee ED, Moons MKG. Preoperative prediction of severe postoperative pain. Pain. 2003 Oct;105(3):415-423. doi: 10.1016/S0304-3959(03)00252-5.'}, {'pmid': '11020770', 'type': 'BACKGROUND', 'citation': 'Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.'}, {'pmid': '16698416', 'type': 'BACKGROUND', 'citation': 'Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.'}, {'pmid': '11356895', 'type': 'BACKGROUND', 'citation': 'Celerier E, Laulin JP, Corcuff JB, Le Moal M, Simonnet G. Progressive enhancement of delayed hyperalgesia induced by repeated heroin administration: a sensitization process. J Neurosci. 2001 Jun 1;21(11):4074-80. doi: 10.1523/JNEUROSCI.21-11-04074.2001.'}, {'pmid': '7681556', 'type': 'BACKGROUND', 'citation': 'Coderre TJ, Katz J, Vaccarino AL, Melzack R. Contribution of central neuroplasticity to pathological pain: review of clinical and experimental evidence. Pain. 1993 Mar;52(3):259-285. doi: 10.1016/0304-3959(93)90161-H.'}, {'pmid': '1981160', 'type': 'BACKGROUND', 'citation': 'Shen KF, Crain SM. Cholera toxin-B subunit blocks excitatory effects of opioids on sensory neuron action potentials indicating that GM1 ganglioside may regulate Gs-linked opioid receptor functions. Brain Res. 1990 Oct 29;531(1-2):1-7. doi: 10.1016/0006-8993(90)90751-v.'}, {'pmid': '9786023', 'type': 'BACKGROUND', 'citation': 'Crain SM, Shen KF. Modulation of opioid analgesia, tolerance and dependence by Gs-coupled, GM1 ganglioside-regulated opioid receptor functions. Trends Pharmacol Sci. 1998 Sep;19(9):358-65. doi: 10.1016/s0165-6147(98)01241-3.'}, {'pmid': '15681961', 'type': 'BACKGROUND', 'citation': 'Richebe P, Rivat C, Laulin JP, Maurette P, Simonnet G. Ketamine improves the management of exaggerated postoperative pain observed in perioperative fentanyl-treated rats. Anesthesiology. 2005 Feb;102(2):421-8. doi: 10.1097/00000542-200502000-00028.'}, {'pmid': '10846153', 'type': 'BACKGROUND', 'citation': 'Woolf CJ, Salter MW. Neuronal plasticity: increasing the gain in pain. Science. 2000 Jun 9;288(5472):1765-9. doi: 10.1126/science.288.5472.1765.'}, {'pmid': '11818772', 'type': 'BACKGROUND', 'citation': 'Rivat C, Laulin JP, Corcuff JB, Celerier E, Pain L, Simonnet G. Fentanyl enhancement of carrageenan-induced long-lasting hyperalgesia in rats: prevention by the N-methyl-D-aspartate receptor antagonist ketamine. Anesthesiology. 2002 Feb;96(2):381-91. doi: 10.1097/00000542-200202000-00025.'}, {'pmid': '12544821', 'type': 'BACKGROUND', 'citation': 'Simonnet G, Rivat C. Opioid-induced hyperalgesia: abnormal or normal pain? Neuroreport. 2003 Jan 20;14(1):1-7. doi: 10.1097/00001756-200301200-00001. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Exaggerated pain and hyperalgesia are major issues after surgery and can lead to chronic pain. Opioid are parts of pain sensitization processes but remain absolutely necessary in the intraoperative period. NMDA receptor antagonists succeed in reducing this pain sensitization process. Recent studies show that in pain and opioid-experienced rats (POER) fentanyl ultra low doses do not induce analgesia, as observed in naive rats, but hyperalgesia. This is the first demonstration that a drug can induce opposite effect depending on individual history. We also observed a strong correlation between this hyperalgesic response in POER and the intensity of hyperalgesia they develop later, after inflammatory or surgical pain. The main aim of this study is to measure the dose effect response to fentanyl "ultra low doses" on human volunteer\'s nociceptive threshold, to determine if such an opposite response profile can be revealed.', 'detailedDescription': '* Principal Objective : "Evaluate fentanyl "ultra low doses" effects on human volunteer\'s nociceptive threshold depending on their prior pain and opioid experience."\n* Secondary Objective : "Confirm the innocuousness of this test (the 3 "ultra low doses" used in this trial will be 10 to 1,000 fold lower than low doses use for anesthesia and analgesia) and to find the fentanyl ultra low dose that could be used to develop a pain sensitisation predictive test."\n* Study design : Bicentric, prospective, randomized, double-blind study.\n\nInclusion criteria :\n\nIn both groups:\n\n* 18-40 years old male volunteer\n* weight: 60 to 85 kg\n* ASA score: 1\n* Informed consent obtained from the patient\n* Gender : Male\n\nIn "operated" group:\n\n\\- At least one history of peripheral surgery under general anesthesia with opioid in the past five years\n\nExclusion criteria :\n\nIn both groups:\n\n* The patient do not accept inclusion to the study\n* Drug or alcohol abuse history\n* Chronic use of analgesic drugs or history of chronic pain\n* Analgesic or opioid consumption within the 12hs preceding the fentanyl or placebo injection\n* Neurological and/or psychiatric disorder, inability to give informed consent\n* Psychological trauma within the two year preceding the inclusion\n* Any contraindication to fentanyl use\n* Use of any medication interacting with fentanyl\n* Exclusion period from the national healthy volunteer register\n* Gender : Female\n\nIn "healthy" group:\n\n\\- Any history of general anesthesia or surgery\n\n* Study plan: comparing two groups that only defer by their surgical and opioid prior experience and will receive three fentanyl ultra low doses (10 to 1,000 fold lower than low doses use for anesthesia and analgesia) and placebo (cross over administration, one week wash out period).\n* Number of subjects : 48'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn both groups:\n\n* 18-40 years old male volunteer\n* Weight: 60 to 85 kg\n* ASA score: 1\n* Informed consent obtained from the patient\n\nIn "operated" group:\n\n* At least one history of peripheral surgery under general anesthesia with opioid in the past five years.\n\nExclusion Criteria:\n\nIn both groups:\n\n* The patients do not accept inclusion to the study\n* Drug or alcohol abuse history\n* Chronic use of analgesic drugs or history of chronic pain\n* Analgesic or opioid consumption within the 12hs preceding the fentanyl or placebo injection\n* Neurological and/or psychiatric disorder, inability to give informed consent\n* Psychological trauma within the two year preceding the inclusion\n* Any contraindication to fentanyl use\n* Use of any medication interacting with fentanyl\n* Exclusion period from the national healthy volunteer register\n\nIn "healthy" group:\n\n* Any history of general anesthesia or surgery'}, 'identificationModule': {'nctId': 'NCT00454259', 'acronym': 'FENTANULD', 'briefTitle': 'Fentanyl Ultra Low Doses Effects on the Nociceptive Threshold', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': "Fentanyl Ultra Low Doses Effects on Human Volunteer's Nociceptive Threshold. Towards a Simple Pharmacological Test Able to Predict Pain Vulnerability, Post Operative Hyperalgesia Development Risk?", 'orgStudyIdInfo': {'id': 'CHUBX 2006/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '0,5 µg/kg', 'interventionNames': ['Drug: Fentanyl/Placebo injection']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '0,05 µg/kg', 'interventionNames': ['Drug: Fentanyl/Placebo injection']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': '0,005 µg/kg', 'interventionNames': ['Drug: Fentanyl/Placebo injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'NaCl 0,9 %', 'interventionNames': ['Drug: Fentanyl/Placebo injection']}], 'interventions': [{'name': 'Fentanyl/Placebo injection', 'type': 'DRUG', 'description': 'Ultra low dose intravenous injection', 'armGroupLabels': ['1', '2', '3', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33604', 'city': 'Pessac', 'state': 'Hôpital Cardiologique', 'country': 'France', 'facility': "CHU de Bordeaux Département d'Anesthésie-Réanimation II", 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}], 'overallOfficials': [{'name': 'Philippe RICHEBE, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Bordeaux'}, {'name': 'Gérard JANVIER, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}, {'name': 'Claude DUBRAY, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}, {'name': 'Alain ESCHALIER, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}, {'name': 'jean DUALE CHRISTIAN, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}, {'name': 'Gisèle PICKERING, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jean-Pierre LEROY / Clinical Research and Innovation Director', 'oldOrganization': 'University Hospital, Bordeaux'}}}}