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

The University of Alabama at Birmingham

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Pain

Treatments: Drug: ropivacaine; Drug: Clonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01986751

F130625002

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 2 patient groups

Clonidine and Ropivacaine

Experimental group

Description:

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).

Treatment:

Drug: Clonidine

Drug: ropivacaine

Ropivacaine

Active Comparator group

Description:

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

Treatment:

Drug: ropivacaine