Addition of Clonidine to Ropivacaine in Adductor Canal Block

NCT03057015 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: CHRMS 17-0107
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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:

1. 1.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).
2. 2.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).
3. 3.Cumulative 24 and 48 hour opioid analgesic use.
4. 4.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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Duration of Analgesia

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

  24 hours for primary outcome

Study Arms (2)

Clonidine

EXPERIMENTAL

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

Drug: Clonidine; Drug: Ropivacaine; Drug: Dexamethasone; Drug: Epinephrine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Ropivacaine; Drug: Dexamethasone; Drug: Epinephrine

Interventions

Clonidine DRUG

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.

Clonidine

Placebo DRUG

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.

Placebo

Ropivacaine DRUG

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.

Clonidine; Placebo

Dexamethasone DRUG

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.

Clonidine; Placebo

Epinephrine DRUG

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.

Clonidine; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Clonidine; Ropivacaine; Dexamethasone; Epinephrine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Borzoo Farhang, DO

  University of Vermont Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Borzoo Farhang, DO

CONTACT

8028819927; borzoo.farhang@uvmhealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor of Anesthesiology

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 17, 2017
• Study Start: May 22, 2017
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: May 3, 2018

Record last verified: 2018-05

Locations

US (1)