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

NCT01986751 | Terminated Phase 1 Results

• 1 other identifier: F130625002
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Mean Time to Onset of Sensory and Motor Block Between the Study Group and the Control Group

  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.

  baseline to 72 hours

• Compare the Mean Duration of Sensory and/or Motor Block Between the Study Group and the Control Group

  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.

  baseline to 72 hours

Secondary Outcomes (6)

• 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

• Compare the Opioid Consumption During the First 24 Hours Between the Study Group and the Control Group

  baseline to 24 hours post block

• Compare the Subjects Mean Arterial Blood Pressure Effect of Perineural Clonidine Versus Placebo

  baseline to discharge from hospital (expected 3 days)

• the Mean Time to Discharge After Start of Procedure for Each Group - Control and Study Group.

  baseline to discharge (approximately 72 hours)

• Mean Time to First Analgesic Intake Postoperative Between the Control Group and the Study Group.

  baseline to 24 hours post block

Study Arms (2)

Clonidine and Ropivacaine

EXPERIMENTAL

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; Drug: ropivacaine

Ropivacaine

ACTIVE COMPARATOR

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

Drug: ropivacaine

Interventions

Clonidine DRUG

Also known as: Catapres, Kapvay, Nexiclon, Jenloga, Duraclon

Clonidine and Ropivacaine

ropivacaine DRUG

Clonidine and Ropivacaine; Ropivacaine

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing foot or ankle surgery with popliteal nerve block planned for postoperative analgesia.
• Adult, 19 years of age and older.
• 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.

You may not qualify if:

• Any subject not classified as an ASA 1, 2, or 3.
• Allergy/intolerance to local anesthetic, clonidine, and/or oxycodone.
• Subject with a history of continuous opioid use for greater than one month prior to surgery.
• Pre-existing neurologic deficit in lower extremity (surgical site).
• Clinically significant coagulopathy (hemophilia, von Willebrand disease).
• 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. -

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Pain; Bites and Stings

Interventions

Clonidine; Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Promil Kukreja
• Organization: University of Alabama Birmingham

pkukreja@uabmc.edu

205-996-7025

Study Officials

• Promil Kukreja, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 18, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 4, 2016
• Results First Posted: November 4, 2016

Record last verified: 2016-07

Locations

US (1)