Diffusion Length of Local Anesthetics in the Subparaneural Space and Duration of Analgesia

NCT05437835 | Unknown

• 1 other identifier: KYLL-2022-0490
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Ultrasound-guided popliteal sciatic nerve block is a widely practiced technique to provide anesthesia or analgesia for below-knee surgeries. One study named the space between paraneural sheath and epimysium of sciatic nerve as the subparaneural space. It has been reported that injection into the subparaneural space has several advantages (improved the quality of the sensory block and resulted in a longer block duration) over conventional perineural injection. The investigators conducted this prospective randomized study to test the hypothesis that, during ultrasound-guided single popliteal sciatic nerve block, diffusion length of local anesthetics in the subparaneural space could predict anesthetic effect and duration of analgesia. The results of this study will develop a novel indicator to facilitate personalized medicine for patients receiving sciatic block.

Conditions

Lower Extremity Fracture

Outcome Measures

Primary Outcomes (1)

• Diffusion length of ropivacaine and duration of analgesia

  The relationship of diffusion length of 0.5% ropivacaine in the subparaneural space and duration of analgesia(sensory block time)

  3 days

Secondary Outcomes (1)

• Diffusion length of ropivacaine and duration of motor block time

  3 days

Study Arms (1)

Diffusion length and anesthetic effect

EXPERIMENTAL

diffusion length of local anesthetics in the subparaneural space could predict anesthetic effect and duration of analgesia

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

Ropivacaine 20 ml injection into the subparaneural space of sciatic nerve

Diffusion length and anesthetic effect

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled for elective below-knee surgery under general anesthesia combined with peripheral nerve block were included. Their physical status was rated I to II by the criteria of the American Society of Anesthesiologists (ASA).

You may not qualify if:

• clinically significant coagulopathy, infection at the injection site, allergy to the local anesthetics, severe cardiopulmonary disease (NYHA ≥III), a body mass index \> 35kg/m2, diabetic or other neuropathy, prior surgery in the popliteal region, or receiving opioids for chronic analgesic therapy.

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

Department of Anesthesiology, General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2022
• First Posted: June 29, 2022
• Study Start: July 30, 2022
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

CN (1)