Clinical trial NCT03643822: Adjuncts for Adductor Block: Dexamethasone,Dexmedetomidine, or Combination to Reduce Pain
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
Overall status: RECRUITING
Phase: PHASE4
Conditions: ACL Injury
Keywords: ACB adjuncts
Dexamethasone
Dexmedetomidine
post operative analgesia
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
First posted: 2018-08-23
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: There will be prospective,randomized,controlled,parallel group,factorial,1:1:1:1 allocation,operator,patient and assessor blinded clinical trial.
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Oral opioid consumption
timeFrame: time of the block to 24 hours after
Secondary outcomes:
measure: Intra-operative opioid consumption
timeFrame: Duration of surgery: From start of surgery (defined as anesthesia start) to end of surgery (defined as anesthesia end)
measure: PACU opioid consumption
timeFrame: From time of arrival (hh:mm) in PACU to time of PACU discharge (hh:mm) assessed up to 24 hours
measure: Time to first analgesic request in PACU
timeFrame: 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)
measure: Time to PACU discharge
timeFrame: 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)
measure: Visual Analogue Scale-Pain scores - minimum score = 0 and maximum score = 10
timeFrame: discharge from hospital to 2 days after surgery
measure: Opioid consumption
timeFrame: discharge from hospital to 2 days after surgery
measure: Risk of block-related complications
timeFrame: one week post operatively
measure: Risk of opioid-related side effects
timeFrame: two week post operatively
measure: Quality of recovery-15 (QoR15) (0-10, where 0 = none of the time [poor] and 10 = all of the time [excellent]
timeFrame: discharge from hospital to 24 hours after surgery
measure: Time to hospital discharge
timeFrame: 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
measure: Time to first analgesic request at home (after discharge)
timeFrame: discharge from hospital to 24 hours after surgery
measure: Visual Analogue Scale-Satisfaction scores - where 0 = not satisfied and 10 = very satisfied
timeFrame: evaluated at 12 and 24 hours post-surgery
measure: Presence/absence of nerve block complications
timeFrame: time from block onset to 2 days,2 weeks after surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Richard Brull, MD
role: PRINCIPAL_INVESTIGATOR
References: