Systemic Lidocaine Infusion for Pain Control in Ventral Hernia

NCT03484650 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 2344
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Ventral hernia repair leads to more than expected pain. This is thought to be secondary to nerve pain at the lateral transfixion sutures. Systemic lidocaine given pre-op has in other situations decreased neurogenic pain. This study will examine its effects on pain experienced after ventral hernia repair.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Post-operative pain

  Amount of morphine equivalents opioid medication used 30 days post-op

  30 days

Study Arms (2)

Control

PLACEBO COMPARATOR

Patients will receive standard care plus infusion of placebo

Other: Placebo

Lidocaine

EXPERIMENTAL

Patients will receive lidocaine infusions peri-operatively

Drug: Lidocaine Hydrochloride

Interventions

Lidocaine Hydrochloride DRUG

Lidocaine bolus to be given 1 hour pre-operatively

Also known as: Bolus of lidocaine

Lidocaine

Placebo OTHER

Control patients will receive a placebo bolus and infusion of saline to match the experimental arm.

Control

Eligibility Criteria

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

You may qualify if:

• Age over 18 Ventral hernia Elective operation Surgeon anticipates mesh

You may not qualify if:

• Age less than 18 Incapable of informed consent Comorbid condition that precludes lidocaine Pregnancy Emergency procedures No mesh History of narcotic abuse

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sandy L Fogel, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The patient, physician, and data abstractors will be blinded to the arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chief of Carilion Clinic General Surgery

Model Details: Prospective randomized controlled trial

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 2, 2018
• Study Start: January 14, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)