Clinical trial 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
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Phantom Limb Pain
Amputation
Anesthesia, Local
Lead sponsor: G.Gennimatas General Hospital
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
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.
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.
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.
Secondary outcomes:
measure: Postoperative morphine consumption
timeFrame: Up to 3 days after surgery (DAY 0), i. e. until DAY 3
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
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
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
Other outcomes:
Locations:
city: Athens
country: Greece
facility: G. Gennimatas General Hospital
state: Attiki
Study officials:
affiliation: G.Gennimatas General Hospital
name: Dimitrios Katsaros
role: PRINCIPAL_INVESTIGATOR
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