Adjuncts for Adductor Block: Dexamethasone,Dexmedetomidine, or Combination to Reduce Pain

NCT03643822 | Terminated DMC

• 1 other identifier: 2018-0164-B
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this multi-centered study is to evaluate the effects of two distinct Adductor Canal Block (ACB) adjuncts, dexamethasone and dexmedetomidine, and their combination, on postoperative analgesia in patients undergoing Anterior Cruciate Ligament (ACL) Repair.

Conditions

ACL Injury

Keywords

ACB adjuncts; Dexamethasone; Dexmedetomidine; post operative analgesia

Outcome Measures

Primary Outcomes (1)

• Oral opioid consumption

  Cumulative 24 hour oral morphine equivalent consumption

  time of the block to 24 hours after

Secondary Outcomes (13)

• Intra-operative opioid consumption

  Duration of surgery: From start of surgery (defined as anesthesia start) to end of surgery (defined as anesthesia end)

• PACU opioid consumption

  From time of arrival (hh:mm) in PACU to time of PACU discharge (hh:mm) assessed up to 24 hours

• Time to first analgesic request in PACU

  From time of arrival in PACU (hh:mm) up to time of PACU discharge (hh:mm) assessed in minutes up to 24 hours ((e.g. patient arrives in PACU 12:00 then patient is given first pain medication in PACU at 12:30; Time to first analgesic request = 30 min)

• Time to PACU discharge

  From time of arrival (hh:mm) in PACU to time discharged (hh:mm) from PACU assessed in minutes (e.g. patient arrives in PACU 12:00 then patient discharged from PACU 12:30; Time to PACU discharge = 30 min)

• Visual Analogue Scale-Pain scores - minimum score = 0 and maximum score = 10

  discharge from hospital to 2 days after surgery

Study Arms (4)

Dexamethasone vs. Control comparison

ACTIVE COMPARATOR

Freezing + dexamethasone(4mg)+1 ml of saline

Drug: Dexamethasone 4mg; Other: Saline

Dexmedetomidine vs. Control comparison

ACTIVE COMPARATOR

Freezing + dexmedetomidine(50ug) + 1.5 ml of saline

Drug: Dexmedetomidine; Other: Saline

Dexamethasone and Dexmedetomidine

ACTIVE COMPARATOR

Freezing+dexamethasone(4mg)+dexmedetomidine(50ug) + 0.5 ml of saline

Drug: Dexamethasone 4mg; Drug: Dexmedetomidine; Other: Saline

Control Group-Placebo

SHAM COMPARATOR

Freezing + 2ml saline

Other: Saline

Interventions

Dexamethasone 4mg DRUG

To guarantee rapid onset as well as effective postoperative analgesia, a 20 mL volume of local anesthetic has been selected for performing the ACB. The block solution will be a 20 ml volume for all groups, prepared by mixing 18 ml of ropivacaine 0.5% mixed with an additional 2 ml prepared according to the randomization.

Also known as: Preservative free Dexamethasone

Dexamethasone and Dexmedetomidine; Dexamethasone vs. Control comparison

Dexmedetomidine DRUG

To guarantee rapid onset as well as effective postoperative analgesia, a 20 mL volume of local anesthetic has been selected for performing the ACB. The block solution will be a 20 ml volume for all groups, prepared by mixing 18 ml of ropivacaine 0.5% mixed with an additional 2 ml prepared according to the randomization.

Also known as: Dexmedetomidine Hydrochloride 0.5 MG/ML

Dexamethasone and Dexmedetomidine; Dexmedetomidine vs. Control comparison

Saline OTHER

Control/Placebo intervention

Control Group-Placebo; Dexamethasone and Dexmedetomidine; Dexamethasone vs. Control comparison; Dexmedetomidine vs. Control comparison

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• English Speaking
• ASA 1-3 patients
• BMI \<40

You may not qualify if:

• Refusal or inability to provide informed consent
• Any contraindication to regional anesthesia including coagulopathy or bleeding diathesis, allergy to local anesthetics, infection, nerve injury or malignancy at the site of the block
• History of alcohol/drug dependence
• History of long term opioid intake or chronic pain disorder
• History of preexisting neuropathy in the operative leg
• History of significant psychiatric conditions that may affect patient assessment
• Inability to understand the informed consent and demands of the study
• Allergy to any of the components of the multimodal analgesic regimen
• Revision of ACL repair
• Diabetes
• Significant bradycardia (baseline heart rate ≤ 40 beats per minute)

Sponsors & Collaborators

• Women's College Hospital: lead
• University Health Network, Toronto: collaborator

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Dexamethasone; Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Richard Brull, MD

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients who give written informed consent will be randomly assigned on the day of surgery to either of the four study groups using a computer-generated block randomization schedule in blocks of varying sizes. Group allocation will not be disclosed to the anesthesiologist performing the ACB. An anesthesia assistant will receive an opaque envelope containing the result of randomization, and will prepare the block study solution in identical syringes. The patient receiving ACB will also be blinded to the study solution injected. Furthermore, outcome assessment will be performed by a blinded research assistant.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be prospective,randomized,controlled,parallel group,factorial,1:1:1:1 allocation,operator,patient and assessor blinded clinical trial.

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: August 23, 2018
• Study Start: February 21, 2020
• Primary Completion: April 16, 2026
• Study Completion: April 16, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

CA (1)