Preoperative Continuous Sciatic Perineural Analgesia in Patients Undergoing Lower Limb Revascularization

Completed

• Conditions: Peripheral Vascular Disease; Ischemic Leg

• Registration Number: NCT04286971
• Lead Sponsor: Hospital Municipal Miguel Couto

Brief Summary

This study evaluates the pain score numerical rating, after sciatic analgesic continuous block, in patients with ischemic pain before surgery of limb revascularization. All patients received those blocks to control ischemic severe pain.

Detailed Description

Peripheral Obstructive Arterial Disease (PAD) is a disease with a prevalence of 10 to 25% in the population over 55 years, increasing with age, and may have disabling pain as a symptom, and sometimes the surgical approach is required. In the context of public hospital in Rio de Janeiro, where patients need to wait for surgery, the Anesthesiology and Acute Pain service routinely has sciatic nerve analgesic block in the popliteal region as a preoperative procedure.

The primary objective of the present study is to describe a series of cases where the technique was applied in order to relieve the pain of these patients, following the Pain Score Numerical rating as a reference. Secondary objectives will be to describe difficulties associated with the technique and possible associated adverse factors.

Study Timeline

• Study Start: 2020-02-19
• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-27
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-15
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• preoperative continuous sciatic-popliteal nerve block
• lower limb angioplasty
• peripheral arterial disease;
• between 2017 and 2018 years;
• correct filling of numerical rating pain evaluation in the medical record

Exclusion Criteria

• peripheral block to treat another pathology or condition in te same patient;
• peripheral block at another concomitant site (other than the popliteal);
• No adequate record of the care received in the medical record
• if medical record is not available during the data collection period

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in numerical pain scale	24 hours after placement of sciatic catheter	Numerical Pain Scale (END) self-assessed by the patient before and after 24 hours of continuous analgesic block of the sciatic nerve, with infusion of levobupivacaine 0,125% or ropivacaine 0,2%. The scale score is 0-10 (0= no pain; 10 = pain as bad as can be)

Secondary Outcome Measures

Name	Time	Method
change in numerical pain scale	72 hours after placement of sciatic catheter	Numerical Pain Scale (END) self-assessed by the patient before and after 72 hours of continuous analgesic block of the sciatic nerve, with infusion of levobupivacaine 0,125% or ropivacaine 0,2%. The scale score is 0-10 (0= no pain; 10 = pain as bad as can be)
classification of technique difficulties	72 hours after placement of sciatic catheter	To report, qualitatively, the presence of variations or difficulties in the use of the technique, such as: failure of the technique (FT); existence of concomitant venous analgesia (VA); inadequate registration of the technique (IR)
classifications of possible complications	72 hours after placement of sciatic catheter	Report, qualitatively, the presence of possible complications, such as: hyperemia of the catheter insertion site (HC); the presence of pus (PUS); catheter displacement (CD)

Trial Locations

Locations (1)

Rafael M Linhares; 🇧🇷 Rio de Janeiro, Brazil