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

NCT06693427 | Completed

• 1 other identifier: GGennimatasGH 8473
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Phantom Limb Pain; Amputation; Anesthesia, Local

Outcome Measures

Primary Outcomes (3)

• Presence of phantom limb pain

  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)

  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.

• Presence of phantom limb pain

  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

  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.

• Presence of phantom limb pain

  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

  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.

Secondary Outcomes (4)

• Postoperative morphine consumption

  Up to 3 days after surgery (DAY 0), i. e. until DAY 3

• Postoperative pain

  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

• Postoperative pain

  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

• Postoperative pain

  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

Study Arms (2)

General Anesthesia

Patients receiving general anesthesia only.

General Anesthesia + Blocks

Patients receiving general anesthesia and peripheral nerve blocks

Procedure: Peripheral Nerve Block

Interventions

Peripheral Nerve Block PROCEDURE

Femoral and Sciatic Nerve Blocks

General Anesthesia + Blocks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Patients undergoing lower limb amputation 10cm cephalad or 10cm caudal of the knee, due to Peripheral Arterial Disease

You may not qualify if:

• Any form of dementia
• 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

Sponsors & Collaborators

• DIMITRIOS KATSAROS: lead

Study Sites (1)

G. Gennimatas General Hospital

Athens, Attica, 11527, Greece

Location

Related Publications (17)

• 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: 12849487 BACKGROUND

• 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: 34088614 BACKGROUND

• 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: 25060393 BACKGROUND

• 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: 21368651 BACKGROUND

• 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: 22161403 BACKGROUND

• 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: 25832306 BACKGROUND

• 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: 29561531 BACKGROUND

• 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: 33100802 BACKGROUND

• 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: 18422201 BACKGROUND

• 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: 25139251 BACKGROUND

• 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: 31281981 BACKGROUND

• 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: 34853109 BACKGROUND

• 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: 14622683 BACKGROUND

• 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: 11464349 BACKGROUND

• 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: 22110933 BACKGROUND

• 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: 19908106 BACKGROUND

• 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.

  PMID: 30983591 BACKGROUND

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Dimitrios Katsaros

  G.Gennimatas General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dimitrios Katsaros, MD

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: November 18, 2024
• Study Start: November 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

GR (1)