NCT03643822

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

Adjuncts for Adductor Block: Dexamethasone,Dexmedetomidine, or Combination to Reduce Pain. A Randomized Controlled Comparison of the Analgesic Effects Following ACL Repair

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: Women's College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ACL Injury

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.
OTHER	Saline	Control/Placebo intervention

Timeline

• Start date: 2020-02-21
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2018-08-23
• Last updated: 2025-03-27

Locations

1 site across 1 country: Canada