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Addition of Clonidine to Ropivacaine in Adductor Canal Block

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clonidine
Placebo
Ropivacaine
Dexamethasone
Epinephrine
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Men and women ages 18 and older
  • ASA physical status classification system I, II and III (healthy patient or patient with mild to moderate systemic disease)
  • Patient coming in for elective total knee arthroplasty under general or neuraxial anesthesia and postoperative adductor canal block
  • Patients staying for at least 24 hrs post operatively
  • Patients who provide informed consent
  • Patients presenting for surgery >1 hour in length and <6 hours.

Exclusion Criteria:

  • History of recent common colds, upper respiratory infections or immune deficiencies
  • Patients allergic to clonidine
  • Pregnant women (all women of childbearing age undergo pregnancy testing prior to anesthesia as per UVMMC peri-operative protocol)
  • Patients who are already on chronic clonidine therapy for management of blood pressure
  • Patients on chronic opioid therapy defined as more than 10 mg of oxycodone per day (or equivalent doses of other opioid analgesics)

Sites / Locations

  • University of Vermont Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Clonidine

Placebo

Arm Description

50 mcg clonidine + 0.5% ropivacaine + 2 mg dexamethasone + 5 mcg/ml epinephrine in 20 ml solution

0.5 ml normal saline + 0.5% ropivacaine + 2 mg dexamethasone + 5 mcg/ml epinephrine in 20 ml solution

Outcomes

Primary Outcome Measures

Duration of Analgesia
the time interval between placement of adductor canal block to the first request of opioid analgesic by patients

Secondary Outcome Measures

Full Information

First Posted
February 13, 2017
Last Updated
May 2, 2018
Sponsor
University of Vermont
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1. Study Identification

Unique Protocol Identification Number
NCT03057015
Brief Title
Addition of Clonidine to Ropivacaine in Adductor Canal Block
Official Title
Addition of Clonidine to Ropivacaine in Adductor Canal Block for Postoperative Pain Relief in Total Knee Arthroplasty: A Prospective Randomized Double Blind Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
February 28, 2019 (Anticipated)
Study Completion Date
February 28, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Total knee arthroplasty (knee replacement) is a common orthopedic procedure for osteoarthritis. This procedure is performed either under general anesthesia or spinal anesthesia; after the procedure in the recovery room, these patients undergo adductor canal block, which is a nerve block to provide 8-14 hours of postoperative pain control. For this nerve block, 15-20 ml of local anesthetic is combined with adjuvant medications to improve the quality of pain control as well as the duration of pain relief. The primary local anesthetic used for adductor canal block is ropivacaine, and the commonly used adjuvants are epinephrine and dexamethasone. There is conflicting data available in the literature regarding efficacy of addition of clonidine to the local anesthetic injection in peripheral nerve blocks, and there is no data assessing the efficacy of this medication in adductor canal blocks. Once the consent process is completed, patients are enrolled in two arms. Upon conclusion of surgery, a sealed and coded envelope with either clonidine or the placebo syringe will be given to the acute pain service staff performing the nerve block. This will be mixed with local anesthetic solution and injected in the adductor canal under ultrasound guidance. The primary outcome measure will be the duration of analgesia, which will be assessed as the time interval between placement of adductor canal block to the first request of opioid analgesic by patients (which will be obtained from hospital electronic medical records). Secondary outcomes will include: Duration of sensory block, which will be assessed as the time interval between injection of local anesthetic and report of postoperative pain of 3 or more on an 11 point scale (0=no pain; 10= worst pain imaginable) by the patient (this will be assessed every 4 hours). Duration of motor block, which will be assessed as the time interval between the onset of motor block to complete recovery of motor block by assessing straight leg raise strength (this will be assessed every 4 hours). Cumulative 24 and 48 hour opioid analgesic use. Post-block pain scores, evaluated by an 11 point pain score (0-10), which will be done every 15 minutes for the first hour after surgery and every 4 hours thereafter for 24 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clonidine
Arm Type
Experimental
Arm Description
50 mcg clonidine + 0.5% ropivacaine + 2 mg dexamethasone + 5 mcg/ml epinephrine in 20 ml solution
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.5 ml normal saline + 0.5% ropivacaine + 2 mg dexamethasone + 5 mcg/ml epinephrine in 20 ml solution
Intervention Type
Drug
Intervention Name(s)
Clonidine
Intervention Description
50 mcg Clonidine added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in the treatment group.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal saline added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in the placebo group.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Clonidine or Placebo added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in both treatment and placebo groups.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Clonidine or Placebo added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in both treatment and placebo groups.
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Intervention Description
Clonidine or Placebo added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in both treatment and placebo groups.
Primary Outcome Measure Information:
Title
Duration of Analgesia
Description
the time interval between placement of adductor canal block to the first request of opioid analgesic by patients
Time Frame
24 hours for primary outcome

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men and women ages 18 and older ASA physical status classification system I, II and III (healthy patient or patient with mild to moderate systemic disease) Patient coming in for elective total knee arthroplasty under general or neuraxial anesthesia and postoperative adductor canal block Patients staying for at least 24 hrs post operatively Patients who provide informed consent Patients presenting for surgery >1 hour in length and <6 hours. Exclusion Criteria: History of recent common colds, upper respiratory infections or immune deficiencies Patients allergic to clonidine Pregnant women (all women of childbearing age undergo pregnancy testing prior to anesthesia as per UVMMC peri-operative protocol) Patients who are already on chronic clonidine therapy for management of blood pressure Patients on chronic opioid therapy defined as more than 10 mg of oxycodone per day (or equivalent doses of other opioid analgesics)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Borzoo Farhang, DO
Phone
8028819927
Email
borzoo.farhang@uvmhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Borzoo Farhang, DO
Organizational Affiliation
University of Vermont Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Borzoo Farhang, DO
Phone
802-881-9927
Email
borzoo.farhang@uvmhealth.org
First Name & Middle Initial & Last Name & Degree
Borzoo Farhang, DO

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Addition of Clonidine to Ropivacaine in Adductor Canal Block

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