Medial Forefoot Block for Analgesia After Foot Surgery

NCT ID: NCT01445249

Last Updated: 2019-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Forefoot surgery includes bunion surgery and similar reconstructive bone cutting surgery and is very painful. Local anaesthetic nerve blocks are used to provide pain relief after this work. The purpose of this study is to compare two techniques: one using anatomical landmarks alone to guide local anaesthetic infiltration, the other using peripheral nerve stimulation to guide local anaesthetic infiltration (termed medial forefoot block). The two techniques will be compared for reliability of postoperative analgesia.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

More extensive description not desired.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hallux Valgus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Landmark guided ankle block

This group will receive a landmark guided ankle block.

Group Type ACTIVE_COMPARATOR

Landmark guided ankle block.

Intervention Type PROCEDURE

25-30mls 0.5% levobupivacaine will be infiltrated to provide a landmark guided ankle block.

This group will be given a PNS guided ankle block

Peripheral nerve stimulation will be used in this group to guide local anaesthetic infiltration. The technique is termed medial forefoot block.

Group Type ACTIVE_COMPARATOR

PNS guided block.

Intervention Type PROCEDURE

This group will have 25-30mls of 0.5% levobupivacaine infiltrated as directed by peripheral nerve stimulation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Landmark guided ankle block.

25-30mls 0.5% levobupivacaine will be infiltrated to provide a landmark guided ankle block.

Intervention Type PROCEDURE

PNS guided block.

This group will have 25-30mls of 0.5% levobupivacaine infiltrated as directed by peripheral nerve stimulation.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Other names not required Other names not required

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Fit adults requiring forefoot surgery with bone cutting

Exclusion Criteria

* Morbid obesity (BMI \> 40)
* Known contraindications to regional anaesthesia
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrew J Coe, MbChB FRCA

Role: PRINCIPAL_INVESTIGATOR

Hull and East Yorks NHS Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Castle Hill Hospital. Castle Road, Cottingham,

Hull, East Yorkshire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

07/H1304/118

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

HeEL Pain Pathways Feasibility Study
NCT06967168 RECRUITING NA