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

• ClinicalTrials.gov Identifier: NCT01986751
• Recruitment Status: Terminated
• First Posted: November 18, 2013
• Results First Posted: November 4, 2016
• Last Update Posted: November 4, 2016
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Promil Kukreja, University of Alabama at Birmingham

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: Clonidine; Drug: ropivacaine	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Perineural Clonidine as an Adjuvant With Ropivacaine for Popliteal Nerve Block in Patients Undergoing Foot and Ankle Surgery
• Study Start Date: January 2014
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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).	Drug: Clonidine; Other Name: Catapres, Kapvay, Nexiclon, Jenloga, Duraclon; Drug: ropivacaine
Active Comparator: Ropivacaine; Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine	Drug: ropivacaine

Outcome Measures

Primary Outcome Measures :

1. Mean Time to Onset of Sensory and Motor Block Between the Study Group and the Control Group [ Time Frame: baseline to 72 hours ]
   Mean time onset of sensory block and motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.
2. Compare the Mean Duration of Sensory and/or Motor Block Between the Study Group and the Control Group [ Time Frame: baseline to 72 hours ]
   Mean duration of sensory and/or motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.

Secondary Outcome Measures :

1. 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 [ Time Frame: baseline to 24 hours post block ]
   The VAS score is measured as 0 - 10 with 0 being no pain to 10 being the worst pain imaginable to assess the efficacy of clonidine to control postoperative pain and patient satisfaction at the time of discharge.
2. Compare the Opioid Consumption During the First 24 Hours Between the Study Group and the Control Group [ Time Frame: baseline to 24 hours post block ]
   Mg equivalent of morphine consumption during the first 24 hours between the study group and the control group
3. Compare the Subjects Mean Arterial Blood Pressure Effect of Perineural Clonidine Versus Placebo [ Time Frame: baseline to discharge from hospital (expected 3 days) ]
   Comparing the mean arterial blood pressure between the study group and the control group to assess the effect of clonidine on blood pressure.
4. the Mean Time to Discharge After Start of Procedure for Each Group - Control and Study Group. [ Time Frame: baseline to discharge (approximately 72 hours) ]
   Comparing the mean hours from start of procedure to discharge between the study group and the control group
5. Mean Time to First Analgesic Intake Postoperative Between the Control Group and the Study Group. [ Time Frame: baseline to 24 hours post block ]
   Comparing the mean time to the first analgesic intake postoperative between the control group and the study group
6. Compare the Mean VAS Scores at 24 Hours Post Procedure to Determine the Patient Satisfaction on Duration of Postoperative Analgesia Between Control Group and Study Group [ Time Frame: baseline to 24 hours ]
   Compare the mean VAS scores at 24 hours between the study group and the control group to assess the efficacy of clonidine to control postoperative pain and patient satisfaction at the time of discharge.

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

   -

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. -

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

• Principal Investigator: Promil Kukreja, MD; University of Alabama at Birmingham

More Information

• Responsible Party: Promil Kukreja, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT01986751
• Other Study ID Numbers: F130625002
• First Posted: November 18, 2013
• Results First Posted: November 4, 2016
• Last Update Posted: November 4, 2016
• Last Verified: July 2016

Keywords provided by Promil Kukreja, University of Alabama at Birmingham:

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

Additional relevant MeSH terms:

Clonidine; Ropivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Analgesics; Antihypertensive Agents; Sympatholytics; Autonomic Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action