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

Completed

• Conditions: Phantom Limb Pain; Amputation; Anesthesia, Local

• Registration Number: NCT06693427
• Lead Sponsor: DIMITRIOS KATSAROS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Study First Submitted: 2024-07-24
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-14
• Last Update Submitted: 2024-11-14
• Study First Posted: 2024-11-18
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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 Outcome Measures

Name	Time	Method
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 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

Trial Locations

Locations (1)

G. Gennimatas General Hospital; 🇬🇷 Athens, Attiki, Greece