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

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ClinicalTrials.gov Identifier: NCT00529074
Recruitment Status : Withdrawn (never activated)
First Posted : September 14, 2007
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia

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

Condition or disease Intervention/treatment Phase
Analgesia Device: Epidural Catheter for Analgesia Not Applicable

Detailed Description:

Epidural anesthesia and analgesia has shown benefits over standard anesthesia/analgesia in many types of Vascular, GI, and Thoracic surgeries. The benefits extended are varied, and include: improvements in cardiac and pulmonary function, decreases in hypercoagulability, reduction of post-operative ileus and decreases in post-operative pain. 1 Epidural pain relief works by exposing the epidural space, with its network of nerve roots, to a flood of analgesics and/or local anesthetic. This is thought to prevent the release of neurotransmitters from afferent pain fibers or interrupt the transmission of pain related information to the dorsal horn of the spinal cord. 2 Several studies have been done on patients undergoing GI surgery with adjunct epidurals (particularly colorectal procedures) and they have shown that ileus and length of stay, is greatly reduced. 3No one has yet extended these benefits to patients undergoing hernia repair.

Laparoscopic ventral hernia repair has recently become a popular choice for both patients and surgeons alike, and has been shown in some studies to reduce wound complications and length of hospital stay. But improvements in post-operative pain, ileus and return to work have been less than hoped for, and as such, adjuncts are being investigated to improve some of these outcomes. In one study of 850 patients in 4 different academic institutions patients had a mean hospital stay of 2.3 days (although a great portion of cases were small ventral hernias that resulted in same-day discharges) and 3% remained hospitalized with a prolonged ileus. The proportion of patients who had prolonged ileus and subsequently longer hospital stays was much greater amongst the patients with larger ventral hernia repairs as well as the patients with recurrences.4 Moreover there has been some suggestion by Ramshaw and colleagues that Laparoscopic Ventral hernia repair is more painful than the classical open hernia operation. 5 One of the explanations is that there may be a component of parietal as well as visceral pain to this procedure; with the visceral pain accompanying the counter-traction on the herniated contents of the sac when taking down adhesions, and the parietal pain from the many full thickness sutures and 3mm tacks used to secure the prosthesis into the abdominal wall.6 In this study, we will test the benefits of epidural anesthesia/analgesia on these patients with complicated Laparoscopic ventral hernia repairs.

As of yet there have been no studies that compare the use of epidural analgesia/anesthesia to conventional anesthesia and narcotics for these patients in relation to their expected length of stay, post-op pain, ileus, or other complications.

  1. Moraca RJ, Sheldon DG, Thirlby RC The role of Epidural Anesthesia and Analgesia in Surgical Practice. Annals of Surgery 2003;238 663-673.
  2. R. J. Fotiadis1, S. Badvie1, M. D.Weston2 and T. G. Allen-Mersh1 Epidural analgesia in gastrointestinal surgery British Journal of Surgery 2004; 91: 828-841
  3. Rodgers A, Walker N et al. Reduction of Post Operative Mortality and Morbidity With Epidural or Spinal Anaesthesia: Results From an Overview of Randomized Trials. Br Med Journal 2000; 321: 1493-1497
  4. Heniford BT. Park A. Ramshaw BJ. Voeller G. Laparoscopic repair of ventral hernias: nine years' experience with 850 consecutive hernias. Annals of Surgery. 238(3):391-9; discussion 399-400, 2003 Sep
  5. Ramshaw B, Esartia Et Al.Comparison of Laparoscopic and open Ventral Hernia Repair; The American Surgeon; Sept 1999; Vol 65: 9 pg 827
  6. Heniford BT, Park, A, ramshaw BJ, Voeller G Laparoscopic Ventral Hernia Repair in 407 Patients. Journal of the American College of Surgeons. Vol 190: 6 PP 645-650 June 2000

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Epidural Anesthesia /Analgesia Versus PCA for Laparoscopic Complex Ventral Hernia Repair: A Randomized Controlled Trial
Study Start Date : February 2006
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Epidural Catheter for Analgesia
    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).


Primary Outcome Measures :
  1. Primary outcome measures will improve. Patients will have a shorter length of stay (1 day less) with pre and post-operative epidural analgesia. [ Time Frame: Post-operatively ]

Secondary Outcome Measures :
  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. [ Time Frame: Post-operatively. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-80 years of age
  • ASA grades I-III
  • Patients with large hernias

    1. requiring mesh greater than or equal to 18cmx 30cm
    2. with a known hernia of at least 10cm x 8cm
    3. Or several smaller hernias that require or may require the coverage referred to in #1

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529074


Locations
United States, Missouri
University of Missouri Hospital and Clinics
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Bruce Ramshaw, MD University of Missouri-Columbia

Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00529074     History of Changes
Other Study ID Numbers: MO-1053537
First Posted: September 14, 2007    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: May 2016

Keywords provided by University of Missouri-Columbia:
Epidural Analgesia

Additional relevant MeSH terms:
Agnosia
Hernia, Ventral
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs