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

Phase 1

Terminated

• Conditions: Pain
• Interventions: Drug: Clonidine; Drug: ropivacaine

• Registration Number: NCT01986751
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-31
• Study First Submitted QC: 2013-11-11
• Study First Posted: 2013-11-18
• Study Start: 2014-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-07
• Results First Submitted: 2016-07-20
• Results First Submitted QC: 2016-09-15
• Last Update Submitted: 2016-09-15
• Results First Posted: 2016-11-04
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clonidine and Ropivacaine	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).
Ropivacaine	ropivacaine	Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine
Clonidine and Ropivacaine	Clonidine	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).

Primary Outcome Measures

Name	Time	Method
Mean Time to Onset of Sensory and Motor Block Between the Study Group and the Control Group	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.
Compare the Mean Duration of Sensory and/or Motor Block Between the Study Group and the Control Group	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

Name	Time	Method
Compare the Subjects Mean Arterial Blood Pressure Effect of Perineural Clonidine Versus Placebo	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.
the Mean Time to Discharge After Start of Procedure for Each Group - Control and Study Group.	baseline to discharge (approximately 72 hours)	Comparing the mean hours from start of procedure to discharge between the study group and the control group
Mean Time to First Analgesic Intake Postoperative Between the Control Group and the Study Group.	baseline to 24 hours post block	Comparing the mean time to the first analgesic intake postoperative between the control group and the study group
Compare the Opioid Consumption During the First 24 Hours Between the Study Group and the Control Group	baseline to 24 hours post block	Mg equivalent of morphine consumption during the first 24 hours between the study group and the control group
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	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.
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	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States