Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT06693427
Status:
COMPLETED
Last Update Posted:
2024-11-18
First Post:
2024-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Femoral and Sciatic Nerve Blocks, Combined with General Anesthesia, in Postoperative Pain Levels and Phantom Limb Pain Development in Patients Undergoing Lower Limb Amputation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010591', 'term': 'Phantom Limb'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2024-07-24', 'studyFirstSubmitQcDate': '2024-11-14', 'lastUpdatePostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of phantom limb pain', 'timeFrame': 'Total screening time up to 9 months from day of surgery (DAY 0). Timeframe: DAY 3, DAY 7, DAY 30, DAY 60, DAY 90, DAY 120, DAY 150, DAY 180, DAY 210, DAY 240, DAY 270.', 'description': 'Presence of phantom limp pain and residual limp pain assessed using the Numerical Rating Scale for pain sensation (0-10, 0 being no pain, 10 being the worst imaginable pain)'}, {'measure': 'Presence of phantom limb pain', 'timeFrame': 'Total screening time up to 9 months from day of surgery (DAY 0). Timeframe: DAY 3, DAY 7, DAY 30, DAY 60, DAY 90, DAY 120, DAY 150, DAY 180, DAY 210, DAY 240, DAY 270.', 'description': 'Presence of phantom limp pain and residual limp pain assessed using the Douleur Neuropathique en 4 Questions questionnaire (total scoring 0-10, score of 4 and above indicating presence of neuropathic pain) for neuropathic pain'}, {'measure': 'Presence of phantom limb pain', 'timeFrame': 'Total screening time up to 9 months from day of surgery (DAY 0). Timeframe: DAY 3, DAY 7, DAY 30, DAY 60, DAY 90, DAY 120, DAY 150, DAY 180, DAY 210, DAY 240, DAY 270.', 'description': 'Presence of phantom limp pain and residual limp pain assessed using the painDETECT questionnaire (total scoring 0-38, 0-12 indicating an unlikely component of neuropathic pain, 13-18 an ambiguous result and 19-38 a likely component of neuropathic pain) for neuropathic pain'}], 'secondaryOutcomes': [{'measure': 'Postoperative morphine consumption', 'timeFrame': 'Up to 3 days after surgery (DAY 0), i. e. until DAY 3', 'description': 'All patients will be connected to an electronic pump for administration of morphine as an analgesic agent through a Patient Controlled Analgesia protocol, which enables the administration of morphine only when required by the patient. At the end of the time frame period the total morphine consumption was measured.'}, {'measure': 'Postoperative pain', 'timeFrame': 'Up to 3 days after day of surgery (DAY 0). Assessed at: DAY 0 12 hours after end of surgery, DAY 1 , DAY 2, DAY 3', 'description': 'Postoperative pain assessed using the Numerical Rating Scale for pain sensation (0-10, 0 being no pain, 10 being the worst imaginable pain)'}, {'measure': 'Postoperative pain', 'timeFrame': 'Up to 3 days after day of surgery (DAY 0). Assessed at: DAY 0 12 hours after end of surgery, DAY 1 , DAY 2, DAY 3', 'description': 'Postoperative pain assessed using the Douleur Neuropathique en 4 Questions questionnaire (total scoring 0-10, score of 4 and above indicating presence of neuropathic pain) for neuropathic pain'}, {'measure': 'Postoperative pain', 'timeFrame': 'Up to 3 days after day of surgery (DAY 0). Assessed at: DAY 0 12 hours after end of surgery, DAY 1 , DAY 2, DAY 3', 'description': 'Postoperative pain assessed using the painDETECT questionnaire (total scoring 0-38, 0-12 indicating an unlikely component of neuropathic pain, 13-18 an ambiguous result and 19-38 a likely component of neuropathic pain) for neuropathic pain'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Phantom Limb Pain', 'Amputation', 'Anesthesia, Local']}, 'referencesModule': {'references': [{'pmid': '12849487', 'type': 'BACKGROUND', 'citation': 'Flor H. Phantom-limb pain: characteristics, causes, and treatment. Lancet Neurol. 2002 Jul;1(3):182-9. doi: 10.1016/s1474-4422(02)00074-1.'}, {'pmid': '34088614', 'type': 'BACKGROUND', 'citation': 'Laloo R, Ambler GK, Locker D, Twine CP, Bosanquet DC. Systematic Review and Meta-Analysis of the Effect of Perineural Catheters in Major Lower Limb Amputations. Eur J Vasc Endovasc Surg. 2021 Aug;62(2):295-303. doi: 10.1016/j.ejvs.2021.03.008. Epub 2021 Jun 2.'}, {'pmid': '25060393', 'type': 'BACKGROUND', 'citation': 'Geertzen J, van der Linde H, Rosenbrand K, Conradi M, Deckers J, Koning J, Rietman HS, van der Schaaf D, van der Ploeg R, Schapendonk J, Schrier E, Duijzentkunst RS, Spruit-van Eijk M, Versteegen G, Voesten H. Dutch evidence-based guidelines for amputation and prosthetics of the lower extremity: Rehabilitation process and prosthetics. Part 2. Prosthet Orthot Int. 2015 Oct;39(5):361-71. doi: 10.1177/0309364614542725. Epub 2014 Jul 24.'}, {'pmid': '21368651', 'type': 'BACKGROUND', 'citation': 'Karanikolas M, Aretha D, Tsolakis I, Monantera G, Kiekkas P, Papadoulas S, Swarm RA, Filos KS. Optimized perioperative analgesia reduces chronic phantom limb pain intensity, prevalence, and frequency: a prospective, randomized, clinical trial. Anesthesiology. 2011 May;114(5):1144-54. doi: 10.1097/ALN.0b013e31820fc7d2.'}, {'pmid': '22161403', 'type': 'BACKGROUND', 'citation': 'Alviar MJ, Hale T, Dungca M. Pharmacologic interventions for treating phantom limb pain. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD006380. doi: 10.1002/14651858.CD006380.pub2.'}, {'pmid': '25832306', 'type': 'BACKGROUND', 'citation': 'Tilak M, Isaac SA, Fletcher J, Vasanthan LT, Subbaiah RS, Babu A, Bhide R, Tharion G. Mirror Therapy and Transcutaneous Electrical Nerve Stimulation for Management of Phantom Limb Pain in Amputees - A Single Blinded Randomized Controlled Trial. Physiother Res Int. 2016 Jun;21(2):109-15. doi: 10.1002/pri.1626. Epub 2015 Apr 1.'}, {'pmid': '29561531', 'type': 'BACKGROUND', 'citation': 'Horlocker TT, Vandermeuelen E, Kopp SL, Gogarten W, Leffert LR, Benzon HT. Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy: American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Fourth Edition). Reg Anesth Pain Med. 2018 Apr;43(3):263-309. doi: 10.1097/AAP.0000000000000763. No abstract available.'}, {'pmid': '33100802', 'type': 'BACKGROUND', 'citation': 'Natarajan B, Patel P, Mukherjee A. Acute Lower Limb Ischemia-Etiology, Pathology, and Management. Int J Angiol. 2020 Sep;29(3):168-174. doi: 10.1055/s-0040-1713769. Epub 2020 Jun 27.'}, {'pmid': '18422201', 'type': 'BACKGROUND', 'citation': 'Grant AJ, Wood C. The effect of intra-neural local anaesthetic infusion on pain following major lower limb amputation. Scott Med J. 2008 Feb;53(1):4-6. doi: 10.1258/RSMSMJ.53.1.4.'}, {'pmid': '25139251', 'type': 'BACKGROUND', 'citation': 'Ayling OG, Montbriand J, Jiang J, Ladak S, Love L, Eisenberg N, Katz J, Clarke H, Roche-Nagle G. Continuous regional anaesthesia provides effective pain management and reduces opioid requirement following major lower limb amputation. Eur J Vasc Endovasc Surg. 2014 Nov;48(5):559-64. doi: 10.1016/j.ejvs.2014.07.002. Epub 2014 Aug 16.'}, {'pmid': '31281981', 'type': 'BACKGROUND', 'citation': 'von Plato H, Peltoniemi M, Kauhanen P, Loyttyniemi E, Hamunen K, Kontinen V; FinAPain-1 study group. Combination of perineural and wound infusion after above knee amputation: A randomized, controlled multicenter study. Acta Anaesthesiol Scand. 2019 Nov;63(10):1406-1412. doi: 10.1111/aas.13440. Epub 2019 Jul 19.'}, {'pmid': '34853109', 'type': 'BACKGROUND', 'citation': "Milosevic S, Strange H, Morgan M, Ambler GK, Bosanquet DC, Waldron CA, Thomas-Jones E, Harris D, Twine CP, Brookes-Howell L. Exploring patients' experiences of analgesia after major lower limb amputation: a qualitative study. BMJ Open. 2021 Dec 1;11(12):e054618. doi: 10.1136/bmjopen-2021-054618."}, {'pmid': '14622683', 'type': 'BACKGROUND', 'citation': 'Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.'}, {'pmid': '11464349', 'type': 'BACKGROUND', 'citation': 'Lambert Aw, Dashfield Ak, Cosgrove C, Wilkins Dc, Walker Aj, Ashley S. Randomized prospective study comparing preoperative epidural and intraoperative perineural analgesia for the prevention of postoperative stump and phantom limb pain following major amputation. Reg Anesth Pain Med. 2001 Jul-Aug;26(4):316-21. doi: 10.1053/rapm.2001.23934.'}, {'pmid': '22110933', 'type': 'BACKGROUND', 'citation': 'Subedi B, Grossberg GT. Phantom limb pain: mechanisms and treatment approaches. Pain Res Treat. 2011;2011:864605. doi: 10.1155/2011/864605. Epub 2011 Aug 14.'}, {'pmid': '19908106', 'type': 'BACKGROUND', 'citation': 'Roullet S, Nouette-Gaulain K, Biais M, Bernard N, Benard A, Revel P, Capdevila X, Sztark F. Preoperative opioid consumption increases morphine requirement after leg amputation. Can J Anaesth. 2009 Dec;56(12):908-13. doi: 10.1007/s12630-009-9185-8. Epub 2009 Nov 12.'}, {'pmid': '30983591', 'type': 'BACKGROUND', 'citation': 'Colvin LA, Bull F, Hales TG. Perioperative opioid analgesia-when is enough too much? A review of opioid-induced tolerance and hyperalgesia. Lancet. 2019 Apr 13;393(10180):1558-1568. doi: 10.1016/S0140-6736(19)30430-1.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to determine the effect of femoral and sciatic nerve blocks, combined with general anesthesia, in postoperative pain levels and phantom limb pain development in patients undergoing lower limb amputation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients listed for lower limb amputation 10cm cephalad or 10cm caudal of the knee, due to Peripheral Arterial Disease. All patients presented to the Emergency Department and had completed their surgery in the first 24 hours since presentation. Post-operative follow-up was every 8 hours for the first day, every 12 hours for Day 2-3. Long term follow-up was at 30 days, 3 months, 6 months and 9 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing lower limb amputation 10cm cephalad or 10cm caudal of the knee, due to Peripheral Arterial Disease\n\nExclusion Criteria:\n\n* Any form of dementia\n* Prior chronic neuropathic pain as assessed with DN4 questionnaire\n* Surgery under neuraxial anaesthesia\n* Inability to complete a Numeric Rating Scale to assess pain\n* Contraindication to ropivacaine'}, 'identificationModule': {'nctId': 'NCT06693427', 'briefTitle': 'Effect of Femoral and Sciatic Nerve Blocks, Combined with General Anesthesia, in Postoperative Pain Levels and Phantom Limb Pain Development in Patients Undergoing Lower Limb Amputation', 'organization': {'class': 'OTHER', 'fullName': 'G.Gennimatas General Hospital'}, 'officialTitle': 'Effect of Femoral and Sciatic Nerve Blocks, Combined with General Anesthesia, in Postoperative Pain Levels and Phantom Limb Pain Development in Patients Undergoing Lower Limb Amputation', 'orgStudyIdInfo': {'id': 'GGennimatasGH 8473'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General Anesthesia', 'description': 'Patients receiving general anesthesia only.'}, {'label': 'General Anesthesia + Blocks', 'description': 'Patients receiving general anesthesia and peripheral nerve blocks', 'interventionNames': ['Procedure: Peripheral Nerve Block']}], 'interventions': [{'name': 'Peripheral Nerve Block', 'type': 'PROCEDURE', 'description': 'Femoral and Sciatic Nerve Blocks', 'armGroupLabels': ['General Anesthesia + Blocks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11527', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'G. Gennimatas General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Dimitrios Katsaros', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'G.Gennimatas General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DIMITRIOS KATSAROS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dimitrios Katsaros, MD', 'investigatorFullName': 'DIMITRIOS KATSAROS', 'investigatorAffiliation': 'G.Gennimatas General Hospital'}}}}