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临床试验/NCT03643822
NCT03643822终止不适用

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

Women's College Hospital2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2020年2月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
2
主要终点
Oral opioid consumption

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • English Speaking
  • ASA 1-3 patients

排除标准

  • 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
  • Significant bradycardia (baseline heart rate ≤ 40 beats per minute)

研究组 & 干预措施

Dexamethasone and Dexmedetomidine

Active Comparator

Freezing+dexamethasone(4mg)+dexmedetomidine(50ug) + 0.5 ml of saline

干预措施: Saline (Other)

Dexamethasone vs. Control comparison

Active Comparator

Freezing + dexamethasone(4mg)+1 ml of saline

干预措施: Saline (Other)

Dexmedetomidine vs. Control comparison

Active Comparator

Freezing + dexmedetomidine(50ug) + 1.5 ml of saline

干预措施: Saline (Other)

Control Group-Placebo

Sham Comparator

Freezing + 2ml saline

干预措施: Saline (Other)

Dexamethasone vs. Control comparison

Active Comparator

Freezing + dexamethasone(4mg)+1 ml of saline

干预措施: Dexamethasone 4mg (Drug)

Dexamethasone and Dexmedetomidine

Active Comparator

Freezing+dexamethasone(4mg)+dexmedetomidine(50ug) + 0.5 ml of saline

干预措施: Dexamethasone 4mg (Drug)

Dexmedetomidine vs. Control comparison

Active Comparator

Freezing + dexmedetomidine(50ug) + 1.5 ml of saline

干预措施: Dexmedetomidine (Drug)

Dexamethasone and Dexmedetomidine

Active Comparator

Freezing+dexamethasone(4mg)+dexmedetomidine(50ug) + 0.5 ml of saline

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Oral opioid consumption

时间窗: time of the block to 24 hours after

Cumulative 24 hour oral morphine equivalent consumption

次要结局

  • Intra-operative opioid consumption(Duration of surgery: From start of surgery (defined as anesthesia start) to end of surgery (defined as anesthesia end))
  • Time to PACU discharge(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))
  • Time to hospital discharge(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)
  • Visual Analogue Scale-Pain scores - minimum score = 0 and maximum score = 10(discharge from hospital to 2 days after surgery)
  • Time to first analgesic request 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))
  • Quality of recovery-15 (QoR15) (0-10, where 0 = none of the time [poor] and 10 = all of the time [excellent](discharge from hospital to 24 hours after surgery)
  • PACU opioid consumption(From time of arrival (hh:mm) in PACU to time of PACU discharge (hh:mm) assessed up to 24 hours)
  • Opioid consumption(discharge from hospital to 2 days after surgery)
  • Visual Analogue Scale-Satisfaction scores - where 0 = not satisfied and 10 = very satisfied(evaluated at 12 and 24 hours post-surgery)
  • Risk of block-related complications(one week post operatively)
  • Risk of opioid-related side effects(two week post operatively)
  • Time to first analgesic request at home (after discharge)(discharge from hospital to 24 hours after surgery)
  • Presence/absence of nerve block complications(time from block onset to 2 days,2 weeks after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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