View Clinical Trial (Medical Research Study)
Effectiveness of Adding Transverse Abdominus Plane (TAP) Catheter Blocks to Patient-controlled Analgesia (PCA) in Laparoscopic Colon Resections: a Prospective, Randomized Controlled Study
| City: |
|
Stamford |
| State: |
|
Connecticut |
| Zip Code: |
|
06904 |
| Conditions: |
|
Colorectal Disorders - Observation of Neuromuscular Block |
| Purpose: |
|
The control of postoperative pain has become a major issue in surgery awareness and it is
considered an important measurement of patient satisfaction. Improvements in pain relief,
including stopping pain before it starts (i.e. preemptive treatment) is of great benefit to
the surgical patient. When pain is aggressively addressed, patients respond by recovering
faster.
The use of opioids remains the mainstay to minimize postoperative pain. Lately, long acting
local anesthetic wound infiltration has been widely recognized as a useful adjunct to
multimodal postoperative pain management. On that basis, a system that delivers a continuous
local anesthetic to the surgical wound was developed, and better pain control has been
achieved after several surgical procedures.
In patients undergoing abdominal procedures, such as colon resection, adequate pain control
remains an issue. It is known that innervation to the antero-lateral abdomen is provided by
sensory nerves T7-L1, ilioinguinal and iliohypogastric nerves, which travel through the
transverse abdominis muscle plane (TAP). Local anesthetic block of these nerves has been
described and has shown to be effective for immediate postoperative pain control.
Recently, the use of the On-Q pain relief system with catheters placed within the TAP has
been evaluated. Published results have shown significant improvement of pain control
(Forastiere). The idea of placing the pain catheters at the TAP plane seems to be more
coherent with the anatomical distribution of the sensory nerves trunks. Due to the lack of
prospective trials investigating the effectiveness of a continuous wound infusion with local
anesthetics after general surgery procedures the investigators sought to determine the
efficacy of this technique after laparoscopic colon resection procedures.
|
| Study Summary: |
|
|
| Criteria: |
|
Inclusion Criteria:
- Patients age 18 - 100 years of age undergoing laparoscopic colon resections.
- Patients must be able to read and write English.
Exclusion Criteria:
- Patients undergoing open procedures.
- Lap converted to open procedures.
- Patients with known liver dysfunction, or the following laboratory assays:
ALT/AST/alk. Phos/total bilirubin of 2x ULN
- Cirrhosis Child's class A-C, INR >1.5. There is no specific isolated value of protein
or albumin which would disqualify the subject.
- All emergent/urgent cases taken to the OR for colon resections.
- All patients with previous drug abuse/narcotic abuse history.
- Patients without the mental capacity to consent for the procedure/study.
- Subjects requiring a translator in order to sign the informed consent.
- Subjects with a history of an allergic reaction to local anesthetics or
acetaminophen.
|
| NCT ID: |
|
NCT01592630 |
| Primary Contact: |
|
Charles Littlejohn, MD
Phone: 203-323-8989
Email: cd000684@mindspring.com
|
| Backup Contact: |
|
Email: pumamaheswaran@stamhealth.org
Preetha Umamaheswaran, MD
Phone: 203-276-7152
|
| Location Contact: |
|
Stamford, Connecticut 06904
United States
Preetha Umamaheswaran, MD
Phone: 203-276-7152
Email: pumamaheswaran@stamhealth.org
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 17, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|