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

Primary Purpose

ACL Injury

Status
Active
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Dexamethasone 4mg
Dexmedetomidine
Saline
Sponsored by
Women's College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for ACL Injury focused on measuring ACB adjuncts, Dexamethasone, Dexmedetomidine, post operative analgesia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Women's College Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Dexamethasone vs. Control comparison

Dexmedetomidine vs. Control comparison

Dexamethasone and Dexmedetomidine

Control Group-Placebo

Arm Description

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

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

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

Freezing + 2ml saline

Outcomes

Primary Outcome Measures

Oral opioid consumption
Cumulative 24 hour oral morphine equivalent consumption

Secondary Outcome Measures

Intra-operative opioid consumption
Cumulative intra-operative opioid consumption in morphine equivalent
PACU opioid consumption
Cumulative oral morphine equivalent consumption during time stayed in PACU
Time to first analgesic request in PACU
The time (hh:mm) first pain medication given in PACU
Time to PACU discharge
how fast patient recovered and discharged from PACU (measured in minutes)
Visual Analogue Scale-Pain scores - minimum score = 0 and maximum score = 10
pain scores at 0, 2, 4, 6, 12, 24, 36, and 48 hours postoperatively
Opioid consumption
analgesic consumption at 6, 12, 24, 36, and 48 hours postoperatively
Risk of block-related complications
adverse symptoms related to the block
Risk of opioid-related side effects
adverse symptoms related to oral pain medication consumption
Quality of recovery-15 (QoR15) (0-10, where 0 = none of the time [poor] and 10 = all of the time [excellent]
measured using the Quality of recovery-15 at 12 and 24 hours postoperatively
Time to hospital discharge
Measures of recovery (how many minutes from end of surgery to discharge from hospital)
Time to first analgesic request at home (after discharge)
first time(hh:mm) patient took an oral pain medication
Visual Analogue Scale-Satisfaction scores - where 0 = not satisfied and 10 = very satisfied
A visual analogue scale used to measure how satisfied the study participant is with the pain relief received for shoulder surgery
Presence/absence of nerve block complications
adverse symptoms related to the block

Full Information

First Posted
June 25, 2018
Last Updated
April 24, 2023
Sponsor
Women's College Hospital
Collaborators
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03643822
Brief Title
Adjuncts for Adductor Block: Dexamethasone,Dexmedetomidine, or Combination to Reduce Pain
Acronym
AADDCToR
Official Title
Adjuncts for Adductor Block: Dexamethasone,Dexmedetomidine, or Combination to Reduce Pain. A Randomized Controlled Comparison of the Analgesic Effects Following ACL Repair
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 21, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's College Hospital
Collaborators
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Anterior cruciate ligament repair (ACLR) is a surgical procedure of the knee associated with moderate to severe postoperative pain lasting beyond 24 hours following surgery. Provision of adequate postoperative analgesia is a prerequisite for performing this procedure on outpatient basis. By virtue of their analgesic effects, peripheral nerve blocks (PNBs), such as adductor canal block (ACB), have thus become part of the care standard for this surgical procedure. Though ACB provides effective pain relief, the duration of analgesia associated with this block is limited to eight hours postoperatively. As a result, patients having outpatient ACLR may experience severe pain following discharge, require additional opioid analgesics to control their pain, and even visit the emergency department for acute pain management. Consequently, perioperative care for the young outpatient population undergoing this procedure is an area where improvement is needed. Mixing adjuncts with local anesthetics can prolong the duration of analgesia of PNBs; both dexmedetomidine and dexamethasone have been shown to effectively extend the duration of PNB analgesia by 60% and 80% hours, respectively. The use of dexamethasone is wide spread, and dexmedetomidine is progressively gaining popularity. At Toronto Western Hospital, the use of adjuncts is left to the discretion of the anesthesiologists administering PNB; and dexamethasone is occasionally used to prolong block duration. The alternative approach to prolonging block duration is using ambulatory ACB catheters, but this is an expensive option that is applicable to select patients, and it is not available at the TWH. Importantly, these adjuncts seem to exert their effect through independent mechanisms; thus there may be an advantage to combining adjuncts together. Further prolongation of the duration of analgesia is desirable, as the prolongation of block duration associated with each of these two adjuncts, alone, falls short of the duration of worst postoperative pain following ACLR. Consequently, the investigators aimed to explore whether the combination of these two adjuncts offers an incremental benefit over either of them alone, by examining their potential additive or synergistic effect. This randomized controlled trial compares the effect of using perineural dexamethasone, dexmedetomidine, and their combination to Control on the duration of postoperative analgesia in patients having ambulatory ACLR with ACB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury
Keywords
ACB adjuncts, Dexamethasone, Dexmedetomidine, post operative analgesia

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Model Description
There will be prospective,randomized,controlled,parallel group,factorial,1:1:1:1 allocation,operator,patient and assessor blinded clinical trial.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
252 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone vs. Control comparison
Arm Type
Active Comparator
Arm Description
Freezing + dexamethasone(4mg)+1 ml of saline
Arm Title
Dexmedetomidine vs. Control comparison
Arm Type
Active Comparator
Arm Description
Freezing + dexmedetomidine(50ug) + 1.5 ml of saline
Arm Title
Dexamethasone and Dexmedetomidine
Arm Type
Active Comparator
Arm Description
Freezing+dexamethasone(4mg)+dexmedetomidine(50ug) + 0.5 ml of saline
Arm Title
Control Group-Placebo
Arm Type
Sham Comparator
Arm Description
Freezing + 2ml saline
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 4mg
Other Intervention Name(s)
Preservative free Dexamethasone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Dexmedetomidine Hydrochloride 0.5 MG/ML
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Control/Placebo intervention
Primary Outcome Measure Information:
Title
Oral opioid consumption
Description
Cumulative 24 hour oral morphine equivalent consumption
Time Frame
time of the block to 24 hours after
Secondary Outcome Measure Information:
Title
Intra-operative opioid consumption
Description
Cumulative intra-operative opioid consumption in morphine equivalent
Time Frame
Duration of surgery: From start of surgery (defined as anesthesia start) to end of surgery (defined as anesthesia end)
Title
PACU opioid consumption
Description
Cumulative oral morphine equivalent consumption during time stayed in PACU
Time Frame
From time of arrival (hh:mm) in PACU to time of PACU discharge (hh:mm) assessed up to 24 hours
Title
Time to first analgesic request in PACU
Description
The time (hh:mm) first pain medication given in PACU
Time Frame
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)
Title
Time to PACU discharge
Description
how fast patient recovered and discharged from PACU (measured in minutes)
Time Frame
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)
Title
Visual Analogue Scale-Pain scores - minimum score = 0 and maximum score = 10
Description
pain scores at 0, 2, 4, 6, 12, 24, 36, and 48 hours postoperatively
Time Frame
discharge from hospital to 2 days after surgery
Title
Opioid consumption
Description
analgesic consumption at 6, 12, 24, 36, and 48 hours postoperatively
Time Frame
discharge from hospital to 2 days after surgery
Title
Risk of block-related complications
Description
adverse symptoms related to the block
Time Frame
one week post operatively
Title
Risk of opioid-related side effects
Description
adverse symptoms related to oral pain medication consumption
Time Frame
two week post operatively
Title
Quality of recovery-15 (QoR15) (0-10, where 0 = none of the time [poor] and 10 = all of the time [excellent]
Description
measured using the Quality of recovery-15 at 12 and 24 hours postoperatively
Time Frame
discharge from hospital to 24 hours after surgery
Title
Time to hospital discharge
Description
Measures of recovery (how many minutes from end of surgery to discharge from hospital)
Time Frame
From time of end of surgery [(hh:mm) defined as anesthesia end] up to time of hospital discharge (hh:mm) assessed in minutes up to 24 hours (e.g. surgery ends 12:00, then patient discharged from the hospital at 13:00; Time to hospital discharge = 60min
Title
Time to first analgesic request at home (after discharge)
Description
first time(hh:mm) patient took an oral pain medication
Time Frame
discharge from hospital to 24 hours after surgery
Title
Visual Analogue Scale-Satisfaction scores - where 0 = not satisfied and 10 = very satisfied
Description
A visual analogue scale used to measure how satisfied the study participant is with the pain relief received for shoulder surgery
Time Frame
evaluated at 12 and 24 hours post-surgery
Title
Presence/absence of nerve block complications
Description
adverse symptoms related to the block
Time Frame
time from block onset to 2 days,2 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English Speaking ASA 1-3 patients BMI <40 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Brull, MD
Organizational Affiliation
Women's College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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