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

Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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. -

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Clonidine

Drug:ropivacaine

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Clonidine and RopivacaineA 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).

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

Study Status

Terminated

Start Date: January 2014

Completed Date: December 2015

Phase: Phase 1/Phase 2

Type: Interventional

Design:

Primary Outcome: Mean Time to Onset of Sensory and Motor Block Between the Study 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 Between the Control Group and Study Group

Study sponsors, principal investigator, and references

Principal Investigator: Promil Kukreja, MD

Lead Sponsor: University of Alabama at Birmingham

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01986751

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