Clinical trial NCT01986751: Effectiveness of Perineural Clonidine as an Adjuvant With Ropivacaine for Popliteal Nerve Block in Patients Undergoing Foot and Ankle Surgery
Official title: Effectiveness of Perineural Clonidine as an Adjuvant With Ropivacaine for Popliteal Nerve Block in Patients Undergoing Foot and Ankle Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Pain
Keywords: nerve
block
motor blockade
lower extremity pain
nerve block
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2013-11-18
Enrollment: 14
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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. -

Primary outcomes:
measure: Mean Time to Onset of Sensory and Motor Block Between the Study Group and the Control Group
timeFrame: baseline to 72 hours
measure: Compare the Mean Duration of Sensory and/or Motor Block Between the Study Group and the Control Group
timeFrame: baseline to 72 hours
Secondary outcomes:
measure: 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
timeFrame: baseline to 24 hours post block
measure: Compare the Opioid Consumption During the First 24 Hours Between the Study Group and the Control Group
timeFrame: baseline to 24 hours post block
measure: Compare the Subjects Mean Arterial Blood Pressure Effect of Perineural Clonidine Versus Placebo
timeFrame: baseline to discharge from hospital (expected 3 days)
measure: the Mean Time to Discharge After Start of Procedure for Each Group - Control and Study Group.
timeFrame: baseline to discharge (approximately 72 hours)
measure: Mean Time to First Analgesic Intake Postoperative Between the Control Group and the Study Group.
timeFrame: baseline to 24 hours post block
measure: 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
timeFrame: baseline to 24 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Promil Kukreja, MD
role: PRINCIPAL_INVESTIGATOR
References: