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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.
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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone vs. Control comparison | Active Comparator | Freezing + dexamethasone(4mg)+1 ml of saline |
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| Dexmedetomidine vs. Control comparison | Active Comparator | Freezing + dexmedetomidine(50ug) + 1.5 ml of saline |
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| Dexamethasone and Dexmedetomidine | Active Comparator | Freezing+dexamethasone(4mg)+dexmedetomidine(50ug) + 0.5 ml of saline |
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| Control Group-Placebo | Sham Comparator | Freezing + 2ml saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Oral opioid consumption | Cumulative 24 hour oral morphine equivalent consumption | time of the block to 24 hours after |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-operative opioid consumption | Cumulative intra-operative opioid consumption in morphine equivalent | Duration of surgery: From start of surgery (defined as anesthesia start) to end of surgery (defined as anesthesia end) |
| PACU opioid consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Brull, MD | Women's College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's College Hospital | Toronto | Ontario | M5S 1B2 | Canada |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D020927 | Dexmedetomidine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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There will be prospective,randomized,controlled,parallel group,factorial,1:1:1:1 allocation,operator,patient and assessor blinded clinical trial.
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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.
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| 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. |
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| Saline | Other | Control/Placebo intervention |
|
Cumulative oral morphine equivalent consumption during time stayed in PACU
| 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 | 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) | 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 | discharge from hospital to 2 days after surgery |
| Opioid consumption | analgesic consumption at 6, 12, 24, 36, and 48 hours postoperatively | discharge from hospital to 2 days after surgery |
| Risk of block-related complications | adverse symptoms related to the block | one week post operatively |
| Risk of opioid-related side effects | adverse symptoms related to oral pain medication consumption | 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 | 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) | 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 | 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 | evaluated at 12 and 24 hours post-surgery |
| Presence/absence of nerve block complications | adverse symptoms related to the block | time from block onset to 2 days,2 weeks after surgery |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |