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

NCT ID: NCT01986751

Last Updated: 2016-11-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-12-31

Brief Summary

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.

Conditions

Pain

Keywords

nerve; block; motor blockade; lower extremity pain; nerve block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Clonidine and Ropivacaine

A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).

Group Type: EXPERIMENTAL

Clonidine

Intervention Type: DRUG

ropivacaine

Intervention Type: DRUG

Ropivacaine

Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine

Group Type: ACTIVE_COMPARATOR

ropivacaine

Intervention Type: DRUG

Interventions

Clonidine

Intervention Type: DRUG

ropivacaine

Intervention Type: DRUG

Other Intervention Names

Catapres, Kapvay, Nexiclon, Jenloga, Duraclon

Eligibility 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 1. -

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Promil Kukreja

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Promil Kukreja, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

F130625002

Identifier Type: -

Identifier Source: org_study_id