Clinical trial NCT01592630: Effectiveness of Transverse Abdominus Plane Catheter Blocks to Patient-controlled Analgesia in Laparoscopic Colon Resections
Official title: Effectiveness of Adding Transverse Abdominus Plane (TAP) Catheter Blocks to Patient-controlled Analgesia (PCA) in Laparoscopic Colon Resections: a Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Colorectal Disorders
Observation of Neuromuscular Block
Lead sponsor: Stamford Hospital
Sponsor class: OTHER
First posted: 2012-05-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Time to flatus
timeFrame: 1 week
measure: Hospital Length of Stay
timeFrame: 1 week
Secondary outcomes:
measure: Passage of Stool
timeFrame: 1 week
measure: Narcotic use
timeFrame: 1 week
Other outcomes:
Locations:
city: Stamford
country: United States
facility: Colon and Rectal Surgery
state: Connecticut
city: Stamford
country: United States
facility: Stamford Hospital
state: Connecticut
Study officials:
References:
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citation: De Oliveira GS Jr, Fitzgerald PC, Marcus RJ, Ahmad S, McCarthy RJ. A dose-ranging study of the effect of transversus abdominis block on postoperative quality of recovery and analgesia after outpatient laparoscopy. Anesth Analg. 2011 Nov;113(5):1218-25. doi: 10.1213/ANE.0b013e3182303a1a. Epub 2011 Sep 16.