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Clinical Trials/NCT06693427
NCT06693427
Completed
Not Applicable

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

DIMITRIOS KATSAROS1 site in 1 country72 target enrollmentNovember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Phantom Limb Pain
Sponsor
DIMITRIOS KATSAROS
Enrollment
72
Locations
1
Primary Endpoint
Presence of phantom limb pain
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
February 1, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

DIMITRIOS KATSAROS

Dimitrios Katsaros, MD

G.Gennimatas General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • 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)

Study Sites (1)

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