A Pain Study Comparing Two Commonly Used Medications to Treat Pain After Bowel Surgery

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This research study is testing whether the local anesthetic lidocaine is as effective as ropivacaine for post-operative pain control in continuous thoracic paravertebral nerve blocks. Ropivacaine and Lidocaine are FDA-approved drugs that has been successfully used in this hospital for post-operative pain control for the past few years, thus has become the standard drugs used for this nerve block. Lidocaine has numerous potential advantages over ropivacaine, such as faster onset of action, better safety profile and greater anti-inflammatory action. Catheters placed near both sides of a patient's spine for postoperative pain control are called thoracic paravertebral nerve blocks and are a part of routine care. Through those catheters, a "numbing" medication, or local anesthetic, to block the transmission of pain from the surgical incision to the spinal cord, thus reducing pain. The research part of the study is whether subjects will receive either the local anesthetic lidocaine or ropivacaine. The goal of this study is to determine whether the lidocaine controls pain better and facilitates a faster recovery after abdominal surgery than ropivacaine.

In this research study, the investigators will compare patient-reported pain scores, any additional pain medication requirements for adequate pain control, time it takes for bowel function to return to normal following surgery, as well as the incidence of any side effects, such as numbness and weakness, subjects may experience between those receiving lidocaine versus those receiving ropivacaine. The investigators will screen 100 patients and enroll 60 subjects into this study.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jacques E. Chelly; University of Pittsburgh
• Collaborator: University of Pittsburgh
• Treatments: Lidocaine; Ropivacaine

Criteria

Inclusion Criteria:

• ASA I-III subjects

• Ages 18-80 years

• Weight between 60 and 110 Kg

• At least 60in (152cm) tall

• Scheduled for elective open colonic surgery at UPMC Presbyterian Shadyside Hospital in Pittsburgh, Pennsylvania

Exclusion Criteria:

• Age younger than 18 years or older than 80 years

• Any contraindication to the placement of bilateral thoracic paravertebral catheters

• American Society of Anesthesiologists physical status IV or greater

• Chronic painful conditions

• Preoperative opioid use

• Coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively

• Allergy to any of the drugs/agents used study protocol

• Personal or family history of malignant hyperthermia

• Serum creatinine greater than 1.3 g/dl

• Pregnancy

• Having an altered mental status (not oriented to place, person, or time)

• Emergency surgery and those with sepsis, unstable angina, congestive heart disease, valvular heart disease, and severe COPD

• Patient's inability to provide adequate informed consent

• Non-english speaking

• Patient refusal