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

Pain, Postoperative Clinical Trial

— TAP RCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03149783
• Other study ID #: 16-1078
• Status: Recruiting
• Phase: Phase 2
• Start date: February 13, 2018
• Est. completion date: October 31, 2021

Study information

• Verified date: May 2021
• Source: University of Colorado, Denver
• Contact: Douglas Overbey, MD
• Phone: 573-225-7728
• Email: douglas.overbey[@]ucdenver.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local
• Delirium
• Pain, Postoperative

Intervention

Drug:
• Ropivacaine HCL
Ropivacaine injected after placement of catheters, then infused during the operation
• sodium chloride
Placebo

Locations

Country	Name	City	State
United States	Denver Veterans Affairs Medical Center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores	Pain scores from the visual analog scale	Days 0-7 following the operation
Secondary	Amount of anesthetic	MAC of inhalational agent, or total amount of IV anesthetic used during the operation	During the operation
Secondary	Amount of narcotic administered postoperatively	Amount of morphine equivalents per day measured after the operation	Days 0-7 postop