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

ACL Injury Clinical Trial

— AADDCToR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03643822
• Other study ID #: 2018-0164-B
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 21, 2020
• Est. completion date: February 2025

Study information

• Verified date: April 2023
• Source: Women's College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 252
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries

Intervention

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.
• 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

Locations

Country	Name	City	State
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Women's College Hospital	University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral opioid consumption	Cumulative 24 hour oral morphine equivalent consumption	time of the block to 24 hours after
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	Opioid consumption	analgesic consumption at 6, 12, 24, 36, and 48 hours postoperatively	discharge from hospital to 2 days after surgery
Secondary	Risk of block-related complications	adverse symptoms related to the block	one week post operatively
Secondary	Risk of opioid-related side effects	adverse symptoms related to oral pain medication consumption	two week post operatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Presence/absence of nerve block complications	adverse symptoms related to the block	time from block onset to 2 days,2 weeks after surgery