Epidural Anesthesia /Analgesia Versus PCA for Laparoscopic Complex Ventral Hernia Repair: A Randomized Controlled Trial
| Status: | Withdrawn |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 8/17/2016 |
| Start Date: | February 2006 |
| End Date: | February 2006 |
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.
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.
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
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
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
We found this trial at
1
site
Click here to add this to my saved trials
