Randomized Study Comparing the Use of Epidural Analgesia to Intravenous Narcotics for Laparoscopic Colorectal Resection.
| Status: | Completed |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/8/2014 |
| Start Date: | May 2012 |
| End Date: | February 2015 |
| Contact: | Carlos Chavez, MD |
| Email: | chavezc@uci.edu |
| Phone: | 714-456-5396 |
Randomized Clinical Trial Comparing the Use of Perioperative Epidural Analgesia to Conventional Intravenous Narcotics and NSAIDS for Patients Undergoing Laparoscopic Colorectal Resection
Laparoscopic colorectal surgery (LCS) has gained wide acceptance in the treatment of various
pathology from diverticular disease to colon cancer. In comparison to conventional open
surgery LCS has the benefits of shorter hospital stay, reduced postoperative pain, lower
wound-related complication rates, better cosmetic results and earlier return to normal
activities.
Despite the fact that laparoscopic colorectal surgery is done through smaller incisions,
there is still a considerable amount of abdominal wall trauma with these procedures. This
still can cause a significant amount of postoperative discomfort, which can add to patients'
stress, decreased satisfaction, and prolong length of hospital stay. Postoperative pain can
be difficult to control and has been mainly managed pharmacologically with the use of
narcotics and non-narcotic medications delivered through different routes. The effectiveness
of pain control depends on the medication, its dosage, frequency and route of
administration. The latter is mainly achieved through the intravenous route in the immediate
postoperative period in laparoscopic colorectal surgery patient, as patients are restricted
from having anything by mouth until return of bowel function.
Another route of delivery is the use of local anesthetics as well as opioids via an epidural
catheter. Epidural analgesia (EA) has the potential to offer excellent pain control and
decrease the rate of postoperative ileus. Despite the extensive use of epidural anesthesia
in obstetrics, to date there has been very few studies looking at the effectiveness of
epidural analgesia in laparoscopic colorectal surgery.
The primary purpose of this study is to evaluate the impact of epidural analgesia as
compared to conventional analgesia on the length of hospital stay in patients undergoing
laparoscopic colorectal procedures. The secondary objectives of the study will be to
evaluate patient satisfaction, quality of life, pain control and return of bowel function in
patients treated with either epidural analgesia or intravenous narcotics.
pathology from diverticular disease to colon cancer. In comparison to conventional open
surgery LCS has the benefits of shorter hospital stay, reduced postoperative pain, lower
wound-related complication rates, better cosmetic results and earlier return to normal
activities.
Despite the fact that laparoscopic colorectal surgery is done through smaller incisions,
there is still a considerable amount of abdominal wall trauma with these procedures. This
still can cause a significant amount of postoperative discomfort, which can add to patients'
stress, decreased satisfaction, and prolong length of hospital stay. Postoperative pain can
be difficult to control and has been mainly managed pharmacologically with the use of
narcotics and non-narcotic medications delivered through different routes. The effectiveness
of pain control depends on the medication, its dosage, frequency and route of
administration. The latter is mainly achieved through the intravenous route in the immediate
postoperative period in laparoscopic colorectal surgery patient, as patients are restricted
from having anything by mouth until return of bowel function.
Another route of delivery is the use of local anesthetics as well as opioids via an epidural
catheter. Epidural analgesia (EA) has the potential to offer excellent pain control and
decrease the rate of postoperative ileus. Despite the extensive use of epidural anesthesia
in obstetrics, to date there has been very few studies looking at the effectiveness of
epidural analgesia in laparoscopic colorectal surgery.
The primary purpose of this study is to evaluate the impact of epidural analgesia as
compared to conventional analgesia on the length of hospital stay in patients undergoing
laparoscopic colorectal procedures. The secondary objectives of the study will be to
evaluate patient satisfaction, quality of life, pain control and return of bowel function in
patients treated with either epidural analgesia or intravenous narcotics.
Laparoscopic colorectal surgery has now become the standard of care in the treatment of many
colorectal pathologies. In comparison to open or conventional surgery it has the benefit of
decreased length of hospital stay (1), reduced postoperative pain, earlier return of bowel
function (2,3) , earlier return to normal activities and improved cosmetic results.
Several criteria must be met before patients are discharged from the hospital. These
discharge criteria are the same objective criteria we use to discharge our surgical
patients:
1. Return of bowel function (as manifested by passage of flatus or bowel movement)
2. Ability to tolerate a regular diet
3. Stable vital signs for 24 hrs
4. Good pain control on oral medications
5. Ability to void freely
6. Return to a similar level of preoperative functioning
All attending surgeons will strictly adhere to the above 6 criteria when discharging
patients.
Poor pain control is known to increase the length of hospital stay after surgery. Good pain
control thus becomes essential in order to decrease the length of hospital stay and make
patients more comfortable.
Pain control has been traditionally achieved through the intravenous route with the use of
narcotic and non-narcotic medications. Postoperative pain is mainly incisional in nature and
is due to enhanced responses to mechanical and thermal stimuli in the area of incision (6).
Despite the fact that laparoscopic surgery is done through smaller incisions, several of
these incisions are required to place the different trocars needed to safely perform the
procedure. These incisions still cause a significant amount of pain and discomfort.
Opioid narcotics delivered systemically through the intravenous route are well known for
their side effects, which range from mild nausea to opioid-induced bowel dysfunction (6).
They are also known to prolong postoperative ileus by blocking coordinated bowel motility
after surgery. The pathophysiology of ileus is multifactorial and incompletely understood.
Major mechanisms contributing to ileus include surgical stress from physical manipulation of
the bowel, secretion of inflammatory mediators, changes in fluid balance, hormones and
electrolyte concentrations (7). Postoperative ileus can take several days to resolve and
every effort should be made to help the bowel regain its function. This includes judicious
use of IV fluids, correcting electrolyte abnormalities and finding the right balance between
adequate pain control and delivering the right amount of intravenous pain medications.
Controlling postoperative pain in an adequate manner without substantial systemic side
effects becomes of primary importance. One way would be through the use of epidural
analgesia where local anesthetics are injected through a catheter placed into the epidural
space. The injection can cause both a loss of sensation and a loss of pain, by blocking the
transmission of signals through nerves in or near the spinal cord while preserving motor
function. The epidural space is the space inside the bony spinal canal but outside the
membrane called the Dura mater. Thus there is no contact with the cerebrospinal fluid and
the spinal cord itself.
Several trials of epidural analgesia in colorectal surgery patients have demonstrated the
potential benefits of this technique such as decreased postoperative pain (8-10,12,14-18),
faster return of bowel function with faster resolution of ileus (8,9,12, 14, 16,17) as well
as a decreased incidence of nausea (17). These trials also showed that patients using
epidural analgesia required less pain medications (10,11). A retrospective review from
Sweden demonstrated a reduction in mortality after epidural anesthesia in patients
undergoing rectal resection (19).
However, the results of these reports concerning length of hospital stay, cost and quality
of life have been inconclusive. Most of the trials conducted until now have been very small
with no more than 39 patients in each arm in the largest trial (9-17). The only study that
showed a decreased length of hospital stay consisted of a cohort of 22 patients compared to
a "historic" standard group (12). This study was small and non-randomized (12). The
remaining studies, despite being randomized, were again small and thus have failed to show a
decreased length of hospital stay in patients receiving epidural analgesia as compared to
intravenous analgesia (9-11, 13-15, 16). The hypothesis advocated by some was that if the
epidural decreases postoperative pain and allows for a faster recovery of bowel function
then it should decrease the length of hospital stay. On the other hand, epidurals are
usually left in place for 2-3 days following surgery before patients are transitioned to
different forms of pain medications. This transition might in fact take time and actually
increase the length of hospital stay thus potentially adversely affecting hospital costs. In
addition, all the studies conducted until now have failed to adequately assess quality of
life in patients receiving EA after laparoscopic colectomy.
Other measures that have been shown to reduce length of hospital stay and opioid induced
side effects are with the use of alvimopan which is a peripherally acting μ-opioid receptor
antagonist, recently approved for the reduction of postoperative ileus after colectomy.
Alvimopan was associated with reduced ileus-related morbidity compared with placebo, without
compromising opioid-based analgesia in patients undergoing surgery (20-21). Thus the use of
alvimopan may obviate advocating the use of EA solely to reduce opioid-induced ileus.
This is a large prospective randomized trial recruiting 160 patients in each arm: an
epidural arm and a conventional analgesia one. The trial will be performed in adult patients
undergoing elective laparoscopic colorectal surgery for both benign and malignant conditions
at the University of California, Irvine (UCI). The primary end point of the study would be
to show a difference in length of hospital stay of one day between the 2 groups, and the
secondary end points would be to show a decreased incidence of pain, earlier return of bowel
function, earlier ambulation, better quality of life, less incidence of complications and
side effects in the epidural group. This will be the largest randomized trial looking at the
use of epidural analgesia in laparoscopic colorectal surgery to be ever conducted. It will
hopefully provide definitive answers regarding any difference in the length of hospital
stay. It will also address issues related to cost-effectiveness as well as quality of life
using validated questionnaires, points that were not addressed by previously published data.
colorectal pathologies. In comparison to open or conventional surgery it has the benefit of
decreased length of hospital stay (1), reduced postoperative pain, earlier return of bowel
function (2,3) , earlier return to normal activities and improved cosmetic results.
Several criteria must be met before patients are discharged from the hospital. These
discharge criteria are the same objective criteria we use to discharge our surgical
patients:
1. Return of bowel function (as manifested by passage of flatus or bowel movement)
2. Ability to tolerate a regular diet
3. Stable vital signs for 24 hrs
4. Good pain control on oral medications
5. Ability to void freely
6. Return to a similar level of preoperative functioning
All attending surgeons will strictly adhere to the above 6 criteria when discharging
patients.
Poor pain control is known to increase the length of hospital stay after surgery. Good pain
control thus becomes essential in order to decrease the length of hospital stay and make
patients more comfortable.
Pain control has been traditionally achieved through the intravenous route with the use of
narcotic and non-narcotic medications. Postoperative pain is mainly incisional in nature and
is due to enhanced responses to mechanical and thermal stimuli in the area of incision (6).
Despite the fact that laparoscopic surgery is done through smaller incisions, several of
these incisions are required to place the different trocars needed to safely perform the
procedure. These incisions still cause a significant amount of pain and discomfort.
Opioid narcotics delivered systemically through the intravenous route are well known for
their side effects, which range from mild nausea to opioid-induced bowel dysfunction (6).
They are also known to prolong postoperative ileus by blocking coordinated bowel motility
after surgery. The pathophysiology of ileus is multifactorial and incompletely understood.
Major mechanisms contributing to ileus include surgical stress from physical manipulation of
the bowel, secretion of inflammatory mediators, changes in fluid balance, hormones and
electrolyte concentrations (7). Postoperative ileus can take several days to resolve and
every effort should be made to help the bowel regain its function. This includes judicious
use of IV fluids, correcting electrolyte abnormalities and finding the right balance between
adequate pain control and delivering the right amount of intravenous pain medications.
Controlling postoperative pain in an adequate manner without substantial systemic side
effects becomes of primary importance. One way would be through the use of epidural
analgesia where local anesthetics are injected through a catheter placed into the epidural
space. The injection can cause both a loss of sensation and a loss of pain, by blocking the
transmission of signals through nerves in or near the spinal cord while preserving motor
function. The epidural space is the space inside the bony spinal canal but outside the
membrane called the Dura mater. Thus there is no contact with the cerebrospinal fluid and
the spinal cord itself.
Several trials of epidural analgesia in colorectal surgery patients have demonstrated the
potential benefits of this technique such as decreased postoperative pain (8-10,12,14-18),
faster return of bowel function with faster resolution of ileus (8,9,12, 14, 16,17) as well
as a decreased incidence of nausea (17). These trials also showed that patients using
epidural analgesia required less pain medications (10,11). A retrospective review from
Sweden demonstrated a reduction in mortality after epidural anesthesia in patients
undergoing rectal resection (19).
However, the results of these reports concerning length of hospital stay, cost and quality
of life have been inconclusive. Most of the trials conducted until now have been very small
with no more than 39 patients in each arm in the largest trial (9-17). The only study that
showed a decreased length of hospital stay consisted of a cohort of 22 patients compared to
a "historic" standard group (12). This study was small and non-randomized (12). The
remaining studies, despite being randomized, were again small and thus have failed to show a
decreased length of hospital stay in patients receiving epidural analgesia as compared to
intravenous analgesia (9-11, 13-15, 16). The hypothesis advocated by some was that if the
epidural decreases postoperative pain and allows for a faster recovery of bowel function
then it should decrease the length of hospital stay. On the other hand, epidurals are
usually left in place for 2-3 days following surgery before patients are transitioned to
different forms of pain medications. This transition might in fact take time and actually
increase the length of hospital stay thus potentially adversely affecting hospital costs. In
addition, all the studies conducted until now have failed to adequately assess quality of
life in patients receiving EA after laparoscopic colectomy.
Other measures that have been shown to reduce length of hospital stay and opioid induced
side effects are with the use of alvimopan which is a peripherally acting μ-opioid receptor
antagonist, recently approved for the reduction of postoperative ileus after colectomy.
Alvimopan was associated with reduced ileus-related morbidity compared with placebo, without
compromising opioid-based analgesia in patients undergoing surgery (20-21). Thus the use of
alvimopan may obviate advocating the use of EA solely to reduce opioid-induced ileus.
This is a large prospective randomized trial recruiting 160 patients in each arm: an
epidural arm and a conventional analgesia one. The trial will be performed in adult patients
undergoing elective laparoscopic colorectal surgery for both benign and malignant conditions
at the University of California, Irvine (UCI). The primary end point of the study would be
to show a difference in length of hospital stay of one day between the 2 groups, and the
secondary end points would be to show a decreased incidence of pain, earlier return of bowel
function, earlier ambulation, better quality of life, less incidence of complications and
side effects in the epidural group. This will be the largest randomized trial looking at the
use of epidural analgesia in laparoscopic colorectal surgery to be ever conducted. It will
hopefully provide definitive answers regarding any difference in the length of hospital
stay. It will also address issues related to cost-effectiveness as well as quality of life
using validated questionnaires, points that were not addressed by previously published data.
Inclusion Criteria:
- Age ≥ 18 years
- Subjects undergoing laparoscopic large bowel resection or rectal resection with
anastomosis and/ or any type of ostomy (end, diverting)
- University of California, Irvine Medical Center inpatients and outpatients scheduled
for surgery
- Elective surgery for benign and malignant conditions
Exclusion Criteria:
- Emergency procedure including procedures done for bowel obstruction, constriction,
fulminant inflammation
- Infection
- Patient participating in other trials that may affect the study outcome
- Subjects with hypersensitivity to any of the anesthesia drugs used per Standard of
Care at UCI Medical Center
- Subjects with history of chronic pain
- Pregnant patients or nursing females
- Subjects with a history of severe cardiovascular, pulmonary, renal, hepatic,
hematologic or systemic disease
- Early Study Termination due to conversion to Open Surgery (subjects who were
converted from laparoscopic to open surgery
- Contraindication to epidural anesthesia (bleeding diathesis, severe hypovolemia,
elevated intracranial pressure, infection at the site of injection, and severe
stenotic valvular heart disease or ventricular outflow obstruction.
We found this trial at
1
site
101 The City Drive South
Orange, California 92868
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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