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Completed

NCT Number: NCT06693427

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

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.

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Key information

Conditions

Phantom Limb Pain Amputation Anesthesia, Local Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Phantom Limb Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

G. Gennimatas General Hospital

Athens, Attica, 11527, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Peripheral nerve block

Procedure

Femoral and Sciatic Nerve Blocks

Primary outcomes

  1. Presence of phantom limb pain

    Time frame: 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 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)

  2. Presence of phantom limb pain

    Time frame: 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 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

  3. Presence of phantom limb pain

    Time frame: 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 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

Secondary outcomes

  1. Postoperative morphine consumption

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

    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.

  2. Postoperative pain

    Time frame: 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 assessed using the Numerical Rating Scale for pain sensation (0-10, 0 being no pain, 10 being the worst imaginable pain)

  3. Postoperative pain

    Time frame: 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 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

  4. Postoperative pain

    Time frame: 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 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

Sponsors and collaborators

Lead sponsor

DIMITRIOS KATSAROS

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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