Adjuncts for Adductor Block: Dexamethasone,Dexmedetomidine, or Combination to Reduce Pain
NCT ID: NCT03643822
Last Updated: 2025-03-27
Study Results
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Basic Information
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RECRUITING
PHASE4
252 participants
INTERVENTIONAL
2020-02-21
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
OTHER
DOUBLE
Study Groups
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Dexamethasone vs. Control comparison
Freezing + dexamethasone(4mg)+1 ml of saline
Dexamethasone 4mg
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.
Saline
Control/Placebo intervention
Dexmedetomidine vs. Control comparison
Freezing + dexmedetomidine(50ug) + 1.5 ml of saline
Dexmedetomidine
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.
Saline
Control/Placebo intervention
Dexamethasone and Dexmedetomidine
Freezing+dexamethasone(4mg)+dexmedetomidine(50ug) + 0.5 ml of saline
Dexamethasone 4mg
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.
Dexmedetomidine
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.
Saline
Control/Placebo intervention
Control Group-Placebo
Freezing + 2ml saline
Saline
Control/Placebo intervention
Interventions
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Dexamethasone 4mg
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.
Dexmedetomidine
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.
Saline
Control/Placebo intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA 1-3 patients
* BMI \<40
Exclusion Criteria
* 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)
18 Years
50 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Women's College Hospital
OTHER
Responsible Party
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Principal Investigators
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Richard Brull, MD
Role: PRINCIPAL_INVESTIGATOR
Women's College Hospital
Locations
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Women's College Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018-0164-B
Identifier Type: -
Identifier Source: org_study_id
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