ACL InjuryAADDCToRNCT03643822
Adjuncts for Adductor Block: Dexamethasone,Dexmedetomidine, or Combination to Reduce Pain
A study testing Dexamethasone 4mg, Dexmedetomidine and Saline in people with ACL Injury, run by Women's College Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- ACL Injury
- What is being tested?
- Dexamethasone 4mg, Dexmedetomidine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- 21 Feb 2020to 16 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- English Speaking
- ASA 1-3 patients
- BMI <40
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjuncts for Adductor Block: Dexamethasone,Dexmedetomidine, or Combination to Reduce Pain. A Randomized Controlled Comparison of the Analgesic Effects Following ACL Repair
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.
Read the 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.
- Conditions
- ACL Injury
- Being tested
- Dexamethasone 4mg, Dexmedetomidine, Saline
- Keywords
- ACB adjuncts, Dexamethasone, Dexmedetomidine, post operative analgesia
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 4mgDrug
Also called Preservative free Dexamethasone
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.
DexmedetomidineDrug
Also called Dexmedetomidine Hydrochloride 0.5 MG/ML
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.
SalineOther
Control/Placebo intervention
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone vs. Control comparison | Active comparator | Freezing + dexamethasone(4mg)+1 ml of saline Receives: Drug: Dexamethasone 4mg; Other: Saline |
| Dexmedetomidine vs. Control comparison | Active comparator | Freezing + dexmedetomidine(50ug) + 1.5 ml of saline Receives: Drug: Dexmedetomidine; Other: Saline |
| Dexamethasone and Dexmedetomidine | Active comparator | Freezing+dexamethasone(4mg)+dexmedetomidine(50ug) + 0.5 ml of saline Receives: Drug: Dexamethasone 4mg; Drug: Dexmedetomidine; Other: Saline |
| Control Group-Placebo | Sham comparator | Freezing + 2ml saline Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral opioid consumption
Cumulative 24 hour oral morphine equivalent consumption
Measured: time of the block to 24 hours after
Secondary outcomes (13)
Intra-operative opioid consumption
Cumulative intra-operative opioid consumption in morphine equivalent
Measured: Duration of surgery: From start of surgery (defined as anesthesia start) to end of surgery (defined as anesthesia end)
PACU opioid consumption
Cumulative oral morphine equivalent consumption during time stayed in PACU
Measured: 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
The time (hh:mm) first pain medication given in PACU
Measured: 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
how fast patient recovered and discharged from PACU (measured in minutes)
Measured: 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
pain scores at 0, 2, 4, 6, 12, 24, 36, and 48 hours postoperatively
Measured: discharge from hospital to 2 days after surgery
Opioid consumption
analgesic consumption at 6, 12, 24, 36, and 48 hours postoperatively
Measured: discharge from hospital to 2 days after surgery
Risk of block-related complications
adverse symptoms related to the block
Measured: one week post operatively
Risk of opioid-related side effects
adverse symptoms related to oral pain medication consumption
Measured: two week post operatively
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
Measured: discharge from hospital to 24 hours after surgery
Time to hospital discharge
Measures of recovery (how many minutes from end of surgery to discharge from hospital)
Measured: 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
Time to first analgesic request at home (after discharge)
first time(hh:mm) patient took an oral pain medication
Measured: discharge from hospital to 24 hours after surgery
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
Measured: evaluated at 12 and 24 hours post-surgery
Presence/absence of nerve block complications
adverse symptoms related to the block
Measured: time from block onset to 2 days,2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start21 Feb 2020
- Primary completion16 Apr 2026
- Study completion16 Apr 2026
Why it stopped: Since study conception and approval in 2018, we have shown that the analgesic benefit of an adductor canal block is not clinically significant in the setting of ACL reconstruction surgery of the knee.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be prospective,randomized,controlled,parallel group,factorial,1:1:1:1 allocation,operator,patient and assessor blinded clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Richard Brull, MD, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643822
- Sponsor's protocol ID
- 2018-0164-B
- Acronym
- AADDCToR
- Status last verified
- Apr 2026
- First submitted
- 25 Jun 2018
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuncts for Adductor Block: Dexamethasone,Dexmedetomidine, or Combination to Reduce Pain. A Randomized Controlled Comparison of the Analgesic Effects Following ACL Repair
- ClinicalTrials.gov ID
- NCT03643822
- Acronym / sponsor ID
- AADDCToR / 2018-0164-B
- Conditions
- ACL Injury
- Keywords
- ACB adjuncts, Dexamethasone, Dexmedetomidine, post operative analgesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Since study conception and approval in 2018, we have shown that the analgesic benefit of an adductor canal block is not clinically significant in the setting of ACL reconstruction surgery of the knee.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 16 Apr 2026 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- There will be prospective,randomized,controlled,parallel group,factorial,1:1:1:1 allocation,operator,patient and assessor blinded clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone vs. Control comparison | Active comparator | Drug: Dexamethasone 4mg, Other: SalineFreezing + dexamethasone(4mg)+1 ml of saline |
| Dexmedetomidine vs. Control comparison | Active comparator | Drug: Dexmedetomidine, Other: SalineFreezing + dexmedetomidine(50ug) + 1.5 ml of saline |
| Dexamethasone and Dexmedetomidine | Active comparator | Drug: Dexamethasone 4mg, Drug: Dexmedetomidine, Other: SalineFreezing+dexamethasone(4mg)+dexmedetomidine(50ug) + 0.5 ml of saline |
| Control Group-Placebo | Sham comparator | Other: SalineFreezing + 2ml saline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- English Speaking
- ASA 1-3 patients
- BMI <40
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone 4mgAlso: Preservative free DexamethasoneTo 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. | Drug | Dexamethasone and Dexmedetomidine, Dexamethasone vs. Control comparison |
| DexmedetomidineAlso: Dexmedetomidine Hydrochloride 0.5 MG/MLTo 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. | Drug | Dexamethasone and Dexmedetomidine, Dexmedetomidine vs. Control comparison |
| SalineControl/Placebo intervention | Other | Control Group-Placebo, Dexamethasone and Dexmedetomidine, Dexamethasone vs. Control comparison, Dexmedetomidine vs. Control comparison |
Primary outcome
Oral opioid consumption
Time frame: time of the block to 24 hours after
Cumulative 24 hour oral morphine equivalent consumption
13 secondary outcomes
Intra-operative opioid consumption
Time frame: Duration of surgery: From start of surgery (defined as anesthesia start) to end of surgery (defined as anesthesia end)
PACU opioid consumption
Time frame: 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
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)
Time to PACU discharge
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)
Visual Analogue Scale-Pain scores - minimum score = 0 and maximum score = 10
Time frame: discharge from hospital to 2 days after surgery
Opioid consumption
Time frame: discharge from hospital to 2 days after surgery
Risk of block-related complications
Time frame: one week post operatively
Risk of opioid-related side effects
Time frame: two week post operatively
Quality of recovery-15 (QoR15) (0-10, where 0 = none of the time [poor] and 10 = all of the time [excellent]
Time frame: discharge from hospital to 24 hours after surgery
Time to hospital discharge
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
Time to first analgesic request at home (after discharge)
Time frame: discharge from hospital to 24 hours after surgery
Visual Analogue Scale-Satisfaction scores - where 0 = not satisfied and 10 = very satisfied
Time frame: evaluated at 12 and 24 hours post-surgery
Presence/absence of nerve block complications
Time frame: time from block onset to 2 days,2 weeks after surgery
Results and safety
The study was stopped early (reason given: Since study conception and approval in 2018, we have shown that the analgesic benefit of an adductor canal block is not clinically significant in the setting of ACL reconstruction surgery of the knee.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
Related trials for ACL Injury
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Brull, MD principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone 4mg, Dexmedetomidine and Saline in people with ACL Injury, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Since study conception and approval in 2018, we have shown that the analgesic benefit of an adductor canal block is not clinically significant in the setting of ACL reconstruction surgery of the knee.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral opioid consumption (time frame: time of the block to 24 hours after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.