Study to Determine if Pre- and Post- Operative TAP Catheters With Ropivacaine Versus Placebo Affects Anesthetic, Narcotic Dosing, and Pain Scores

Study Overview
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Brief Summary
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A randomized controlled trial to determine if pre- and post- operative regional pain control (transversus abdominis plane block) with ropivacaine versus placebo leads to lower anesthetic and narcotic dosing, and alters pain scores. This study plans to learn more about regional anesthesia and pain control during abdominal surgery. The study will gather data about the effectiveness of continuous catheter infusion of local anesthetic after an abdominal operation. Outcomes include pain scores, IV pain medicine requirements, and delirium.

Official Title
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A Randomized Controlled Trial to Determine if Pre- and Post- Operative Regional Pain Control (Transversus Abdominis Plane Block) With Ropivacaine Versus Placebo Leads to Lower Anesthetic and Narcotic Dosing, and Alters Pain Scores

Conditions
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Pain, Postoperative, Delirium, Anesthesia, Local

Intervention / Treatment
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* Drug: Ropivacaine HCL
* Drug: sodium chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >=50 years. Subjects will be undergoing an elective intra-abdominal or abdominal wall operation, including pelvic operations. Surgery specialties included are general surgery, surgical oncology, urology, gynecology, plastic surgery. Exclusion Criteria: Subjects with a history of dementia or aphasia, as visual analog scale and confusion assessment will be unreliable. Patients with an epidural or spinal catheter block. Patients who do not speak English so that a language barrier is not confused with VAS scoring or confusion. Patients who are abusing alcohol defined by a high AUDIT score (>8) will be excluded. History of bipolar disorder or a psychotic disorder (such as a psychotic major depression, schizophrenia, schizoaffective disorder, or psychosis in Alzheimer's disease or other dementia). Patients with a documented allergy to ropivacaine or other sodium channel blockers.

Ages Eligible for Study
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Minimum Age: 50 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Double Blind Trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine<br>Participants will have bilateral TAP catheters placed along with continuous infusion of ropivacaine. | Drug: Ropivacaine HCL<br>* Ropivacaine injected after placement of catheters, then infused during the operation<br>|
| Placebo Comparator: Placebo<br>Participants will have bilateral TAP catheters placed along with continuous infusion of placebo. | Drug: sodium chloride<br>* Placebo<br>* Other names: saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores | Pain scores from the visual analog scale | Days 0-7 following the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of anesthetic | MAC of inhalational agent, or total amount of IV anesthetic used during the operation | During the operation | 
| Amount of narcotic administered postoperatively | Amount of morphine equivalents per day measured after the operation | Days 0-7 postop |