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

University of Colorado Denver (CU Denver)

Status and phase: Unknown; Phase 2

Conditions: Delirium; Anesthesia, Local; Pain, Postoperative

Treatments: Drug: sodium chloride; Drug: Ropivacaine HCL

Study type: Interventional

Funder types: Other

Identifiers

NCT03149783

16-1078

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Ropivacaine

Experimental group

Description:

Participants will have bilateral TAP catheters placed along with continuous infusion of ropivacaine.

Treatment:

Drug: Ropivacaine HCL

Placebo

Placebo Comparator group

Description:

Participants will have bilateral TAP catheters placed along with continuous infusion of placebo.

Treatment:

Drug: sodium chloride