Effectiveness of Perineural Clonidine as an Adjuvant With Ropivacaine for Popliteal Nerve Block in Patients Undergoing Foot and Ankle Surgery

Condition(s) targeted: Pain

Intervention: Clonidine (Drug); ropivacaine (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: University of Alabama at Birmingham

Nerve blocks are used to decrease the amount of pain you have after surgery. We are asking you to take part in a research study. This research study will test whether adding a medicine called clonidine to nerve blocks helps to improve them. Nerve blocks typically last less than a day after surgery. We are looking for ways to make them work better and last longer. Clonidine is approved for use as a blood pressure medicine. Its use in nerve blocks is investigational, but it may help nerve blocks to last longer. Adding clonidine to nerve blocks may also decrease the amount of pain medicine a person has after surgery. All people who enter this study will receive a nerve block with the normal medicine, but half of people will also have clonidine added to their nerve block. This study will enroll 60 participants from UAB hospitals.

Official title: Effectiveness of Perineural Clonidine as an Adjuvant With Ropivacaine for Popliteal Nerve Block in Patients Undergoing Foot and Ankle Surgery

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome:

Compare the onset of sensory and motor block between the control group and the control group

Compare the duration of sensory and motor block between the control group and the control group

Secondary outcome:

Compare the mean VAS scores at 24 hours post procecure to determine the effectiveness of perineural clonidine on duration of postoperative analgesia

Compare the number of subjects taking postoperative opioids to determine the effect of perineural clonidine versus placebo

Compare the subjects mean blood pressure effect of perineural clonidine versus placebo

number of subjects in each group requiring sedation

Determine the effect of perineural clonidine versus placebo on time to discharge

Determine the effect of perineural clonidine versus placebo on postoperative time to first analgesic intake

Compare the mean VAS scores at 24 hours post procedure to determine the patient satisfaction of perineural clonidine on duration of postoperative analgesia

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patient undergoing foot or ankle surgery with popliteal nerve block planned for postoperative analgesia. 2. Adult, 19 years of age and older. 3. Subject classified as American Society of Anesthesiology (ASA) class 1, 2, or 3. The ASA defines these statuses as follows: 1-A normal healthy patient. 2-A patient with mild systemic disease. 3-A patient with severe systemic disease.

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Exclusion Criteria: 1. Any subject not classified as an ASA 1, 2, or 3. 2. Allergy/intolerance to local anesthetic, clonidine, and/or oxycodone. 3. Subject with a history of continuous opioid use for greater than one month prior to surgery. 4. Pre-existing neurologic deficit in lower extremity (surgical site). 5. Clinically significant coagulopathy (hemophilia, von Willebrand disease). 6. Patients who fail to follow the UAB Department of Anesthesiology Algorithm for the Preoperative Management of an Angiotensin Converting Enzyme Inhibitor (ACEI) or an Angiotensin Receptor Blocker (ARB). A copy of the algorithm can be found in Appendix

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University of Alabama at Birmingham, Birmingham, Alabama 35233, United States; Recruiting
Promil Kukreja, MD, PhD, Phone: 205-934-4696, Email: pkukreja@uab.edu
Cindy Louderback, Phone: 205-975-9732, Email: clouderback@uab.edu
Brian D Dishong, MD, Sub-Investigator
Brandon S Brooks, MD, Sub-Investigator
Elizabeht B Driscoll, MD, Sub-Investigator
Ashish Shah, MD, Sub-Investigator

Starting date: January 2014
Last updated: January 8, 2015