Epidural Anesthesia /Analgesia Versus PCA for Laparoscopic Complex Ventral Hernia Repair: A Randomized Controlled Trial

NCT00529074 | Withdrawn

• 1 other identifier: MO-1053537
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

We plan to demonstrate the superiority of epidural anaesthesia/analgesia in repairs of large ventral hernias as compared with a conventional narcotic analgesia regimen. We hypothesize that:

1. 1.Primary outcome measures will improve. Patients will have a shorter length of stay (1 day less) with pre and post-operative epidural analgesia.
2. 2.Secondary outcome measures will also improve. Among them will be VAS pain scores, time to first flatus and bowel movement as well as major and minor complications.

Conditions

Analgesia

Keywords

Epidural Analgesia

Outcome Measures

Primary Outcomes (1)

• Primary outcome measures will improve. Patients will have a shorter length of stay (1 day less) with pre and post-operative epidural analgesia.

  Post-operatively

Secondary Outcomes (1)

• Secondary outcome measures will also improve. Among them will be VAS pain scores, time to first flatus and bowel movement as well as major and minor complications.

  Post-operatively.

Interventions

Epidural Catheter for Analgesia DEVICE

Patients enrolled will be placed into one of two groups of 30 patients. The decision to place the patients in either one of the two groups will be randomized as above. The Epidural group will have a thoracic epidural catheter placed pre-operatively at the T6-T7 level before general anesthesia is given. (using a .1% Marcaine and .1% Meperidine solution) A dose of Ketorolac will be given 15 minutes before the patient will be awakened from anesthesia (provided that there is good renal function and the patient is not hypovolemic) The catheter will be used preoperatively as an adjunct for general anesthesia as well as used postoperatively for continuous epidural analgesia(CEA). The control group will be given general anesthesia alone and post-operative PCA along with NSAIDS before leaving for the recovery room (as above).

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• ASA grades I-III
• Patients with large hernias
• requiring mesh greater than or equal to 18cmx 30cm
• with a known hernia of at least 10cm x 8cm
• Or several smaller hernias that require or may require the coverage referred to in #1

You may not qualify if:

• Age\<18 or \>80
• Poor candidacy for operative treatment
• Previous spinal operations
• Sepsis
• Incarcerated ventral hernias requiring anticoagulation

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Hospital and Clinics

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Bruce Ramshaw, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 11, 2007
• First Posted: September 14, 2007
• Study Start: February 1, 2006
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: August 16, 2016

Record last verified: 2016-05

Locations

US (1)