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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01986751
• Other study ID #: F130625002
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: October 31, 2013
• Last updated: August 21, 2015
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Clonidine

• ropivacaine

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the onset of sensory and motor block between the control group and the control group		baseline to 72 hours	No
Primary	Compare the duration of sensory and motor block between the control group and the control group		baseline to 72 hours	No
Secondary	Compare the mean VAS scores at 24 hours post procecure to determine the effectiveness of perineural clonidine on duration of postoperative analgesia		baseline to 24 hours post block	No
Secondary	Compare the number of subjects taking postoperative opioids to determine the effect of perineural clonidine versus placebo		baseline to 24 hours post block	No
Secondary	Compare the subjects mean blood pressure effect of perineural clonidine versus placebo		baseline to discharge from hospital, expected duration of no more than 3 days	Yes
Secondary	number of subjects in each group requiring sedation		baseline to discharge, an expected duration of no more than 3 days	Yes
Secondary	Determine the effect of perineural clonidine versus placebo on time to discharge	Hours from start of procedure to discharge	baseline to discharge, an expected duration of no more than 72 hours	Yes
Secondary	Determine the effect of perineural clonidine versus placebo on postoperative time to first analgesic intake		baseline to 24 hours post block	Yes
Secondary	Compare the mean VAS scores at 24 hours post procedure to determine the patient satisfaction of perineural clonidine on duration of postoperative analgesia		baseline to 24 hours	No