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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: ACL Injury
• Intervention / Treatment: Drug: Dexamethasone 4mg; Other: Saline; Drug: Dexmedetomidine

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 Type: Interventional
• Enrollment (Anticipated): 252
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 1B2
      • Women's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexamethasone vs. Control comparison; Freezing + dexamethasone(4mg)+1 ml of saline	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.; Other Names: Preservative free Dexamethasone; Other: Saline; Control/Placebo intervention
Active Comparator: Dexmedetomidine vs. Control comparison; Freezing + dexmedetomidine(50ug) + 1.5 ml of saline	Other: Saline; Control/Placebo intervention; 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 Names: Dexmedetomidine Hydrochloride 0.5 MG/ML
Active Comparator: Dexamethasone and Dexmedetomidine; Freezing+dexamethasone(4mg)+dexmedetomidine(50ug) + 0.5 ml of saline	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.; Other Names: Preservative free Dexamethasone; Other: Saline; Control/Placebo intervention; 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 Names: Dexmedetomidine Hydrochloride 0.5 MG/ML
Sham Comparator: Control Group-Placebo; Freezing + 2ml saline	Other: Saline; Control/Placebo intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral opioid consumption	Cumulative 24 hour oral morphine equivalent consumption	time of the block to 24 hours after

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Women's College Hospital
• Collaborators: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2020
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Dexamethasone; post operative analgesia; ACB adjuncts
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexamethasone; Dexamethasone acetate; BB 1101; Dexmedetomidine
• Other Study ID Numbers: 2018-0164-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No