Epidural Anesthesia /Analgesia Versus PCA for Laparoscopic Complex Ventral Hernia Repair: A Randomized Controlled Trial
| Tracking Information | |||||
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| First Received Date ICMJE | September 11, 2007 | ||||
| Last Updated Date | September 20, 2011 | ||||
| Start Date ICMJE | February 2006 | ||||
| Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||
| Change History | Complete list of historical versions of study NCT00529074 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
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. ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Epidural Anesthesia /Analgesia Versus PCA for Laparoscopic Complex Ventral Hernia Repair: A Randomized Controlled Trial | ||||
| Official Title ICMJE | Epidural Anesthesia /Analgesia Versus PCA for Laparoscopic Complex Ventral Hernia Repair: A Randomized Controlled Trial | ||||
| 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:
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| 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.
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Analgesia | ||||
| Intervention ICMJE | 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). |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | August 2013 | ||||
| Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00529074 | ||||
| Other Study ID Numbers ICMJE | MO-1053537 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Bruce Ramshaw, MD, University of Missouri Healthcare | ||||
| Study Sponsor ICMJE | University of Missouri-Columbia | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Missouri-Columbia | ||||
| Verification Date | September 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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