AnalgesiaNCT00529074
Epidural Anesthesia /Analgesia Versus PCA for Laparoscopic Complex Ventral Hernia Repair: A Randomized Controlled Trial
A study testing Epidural Catheter for Analgesia in people with Analgesia, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Epidural Catheter for Analgesia
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Feb 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-80 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
Who cannot join
- Age<18 or >80
- Poor candidacy for operative treatment
- Previous spinal operations
- Sepsis
- Incarcerated ventral hernias requiring anticoagulation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Hospital and Clinics
Columbia, Missouri, 65212
About this study
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:
- Primary outcome measures will improve. Patients will have a shorter length of stay (1 day less) with pre and post-operative epidural analgesia.
- 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.
Read the 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.
- Moraca RJ, Sheldon DG, Thirlby RC The role of Epidural Anesthesia and Analgesia in Surgical Practice. Annals of Surgery 2003;238 663-673.
- 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
- 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
- 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
- Ramshaw B, Esartia Et Al.Comparison of Laparoscopic and open Ventral Hernia Repair; The American Surgeon; Sept 1999; Vol 65: 9 pg 827
- 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
- Conditions
- Analgesia
- Being tested
- Epidural Catheter for Analgesia
- Keywords
- Epidural Analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Catheter for AnalgesiaDevice
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measures will improve. Patients will have a shorter length of stay (1 day less) with pre and post-operative epidural analgesia.
Measured: 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.
Measured: Post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startFeb 2006
- Primary completionFeb 2006
- Study completionFeb 2006
Why it stopped: never activated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce Ramshaw, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529074
- Sponsor's protocol ID
- MO-1053537
- Status last verified
- May 2016
- First submitted
- 11 Sep 2007
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Anesthesia /Analgesia Versus PCA for Laparoscopic Complex Ventral Hernia Repair: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00529074
- Acronym / sponsor ID
- MO-1053537
- Conditions
- Analgesia
- Keywords
- Epidural Analgesia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: never activated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 14 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Primary outcome measures will improve. Patients will have a shorter length of stay (1 day less) with pre and post-operative epidural analgesia.
- 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.
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.
- Moraca RJ, Sheldon DG, Thirlby RC The role of Epidural Anesthesia and Analgesia in Surgical Practice. Annals of Surgery 2003;238 663-673.
- 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
- 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
- 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
- Ramshaw B, Esartia Et Al.Comparison of Laparoscopic and open Ventral Hernia Repair; The American Surgeon; Sept 1999; Vol 65: 9 pg 827
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-80 years of age
- ASA grades I-III
- Patients with large hernias
Key exclusion criteria (5 listed)
- Age<18 or >80
- Poor candidacy for operative treatment
- Previous spinal operations
- Sepsis
- Incarcerated ventral hernias requiring anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural Catheter for AnalgesiaPatients 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). | Device | – |
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Ramshaw, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural Catheter for Analgesia in people with Analgesia, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.