Paravertebral Blocks: Pilot Study to Compare Nerve Stimulation vs. Anatomic Landmarks in Inguinal Hernia Repair

NCT ID: NCT00587704

Last Updated: 2010-02-23

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-05-31

Brief Summary

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

Primary aim:

1\. To compare the nerve stimulation vs. anatomic techniques of paravertebral block of T11-L1 in providing surgical anesthesia for patients undergoing inguinal hernia repair.

Secondary aims:

1. Compare VAS pain scores in the two groups of patients over the first 24 hours.
2. Compare opioid intake over the first 24 hours in the two groups of patients.

Detailed Description

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

Conditions

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

Inguinal Hernia

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

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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

Nerve Stimulation

Use of nerve stimulator for placement of PVB nerve block

Group Type OTHER

PVB using nerve stimulation

Intervention Type PROCEDURE

5ml of 1% ropivacaine injected incrementally

Anatomic landmarks

Use of anatomic landmarks for placement of PVB block

Group Type OTHER

PVB using anatomic landmarks

Intervention Type PROCEDURE

5ml of 1% ropivacaine injected incrementally

Interventions

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

PVB using nerve stimulation

5ml of 1% ropivacaine injected incrementally

Intervention Type PROCEDURE

PVB using anatomic landmarks

5ml of 1% ropivacaine injected incrementally

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* Unilateral open inguinal herniorrhaphy
* Patient must be \>18 years of age
* ASA physical status of I, II, or III
* Patient competent to provide informed consent

Exclusion Criteria

* Patient \< 18 years of age
* Pregnant or lactating women
* Patient unwilling or unable to provide informed consent
* Contraindications to regional anesthesia
* Allergy to amide local anesthetics
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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

Mayo Clinic

Principal Investigators

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

Steven R. Clendenen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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

Mayo Clinic

Jacksonville, Florida, United States

Site Status

Countries

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

United States

Other Identifiers

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

07-002759

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Parastomal Reinforcement With Strattice
NCT00771407 COMPLETED PHASE4