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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06693427

Enrollment

Registered

2024-11-18

Start date

2021-11-01

Completion date

2023-02-01

Last updated

2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation, Anesthesia, Local, Phantom Limb Pain

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.

Interventions

PROCEDUREPeripheral Nerve Block

Femoral and Sciatic Nerve Blocks

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Presence of phantom limb 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 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)

Secondary

Measure	Time frame	Description
Postoperative morphine consumption	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.
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 assessed using the Numerical Rating Scale for pain sensation (0-10, 0 being no pain, 10 being the worst imaginable pain)

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026