Effectiveness of Transverse Abdominus Plane Catheter Blocks to Patient-controlled Analgesia in Laparoscopic Colon Resections

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Adding Transverse Abdominus Plane (TAP) Catheter Blocks to Patient-controlled Analgesia (PCA) in Laparoscopic Colon Resections: a Prospective, Randomized Controlled Study

Conditions
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Colorectal Disorders, Observation of Neuromuscular Block

Intervention / Treatment
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* Drug: 0.2% ropivacaine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine<br>Subjects with TAP catheters attached to the On-Q pump with 0.2% ropivacaine | Drug: 0.2% ropivacaine<br>* On-Q pumps containing 0.2% ropivacaine to be attached to TAP catheters<br>* Other names: Experimental drug;|
| Placebo Comparator: Saline<br>Subjects with TAP catheters attached to the On-Q pump with saline | Drug: Saline<br>* On-Q pumps containing saline to be attached to TAP catheters<br>* Other names: Control/Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to flatus | Post-operative time measurement for the patient to pass flatus | 1 week | 
| Hospital Length of Stay | Post-operative time measurement until patient discharge | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Passage of Stool | Post-operative time measurement for the patient to pass stool | 1 week | 
| Narcotic use | Post-operative measurement of patient narcotic requirements | 1 week |