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
NCT ID: NCT06693427
Last Updated: 2024-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
72 participants
OBSERVATIONAL
2021-11-01
2023-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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General Anesthesia
Patients receiving general anesthesia only.
No interventions assigned to this group
General Anesthesia + Blocks
Patients receiving general anesthesia and peripheral nerve blocks
Peripheral Nerve Block
Femoral and Sciatic Nerve Blocks
Interventions
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Peripheral Nerve Block
Femoral and Sciatic Nerve Blocks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Prior chronic neuropathic pain as assessed with DN4 questionnaire
* Surgery under neuraxial anaesthesia
* Inability to complete a Numeric Rating Scale to assess pain
* Contraindication to ropivacaine
18 Years
ALL
No
Sponsors
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DIMITRIOS KATSAROS
OTHER
Responsible Party
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DIMITRIOS KATSAROS
Dimitrios Katsaros, MD
Principal Investigators
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Dimitrios Katsaros
Role: PRINCIPAL_INVESTIGATOR
G.Gennimatas General Hospital
Locations
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G. Gennimatas General Hospital
Athens, Attica, Greece
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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GGennimatasGH 8473
Identifier Type: -
Identifier Source: org_study_id
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