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临床试验/NCT03990038
NCT03990038终止不适用

Comparison of Two Multimodal Analgesia Regimens for Total Knee Arthroplasty : a Randomized Controlled Trial

Ciusss de L'Est de l'Île de Montréal1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2019年8月1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
发起方
入组人数
2
试验地点
1
主要终点
Pain score during walking (24 hours)

研究概览

简要总结

The improvement of postoperative analgesia is an important issue in orthopedic surgery, especially after total knee arthroplasty The use of a peripheral nerve block such as the adductor canal block is favored since it offers a postoperative analgesia superior to opioids, and also preserves the strength of the quadriceps, as opposed to the femoral block.

The adductor canal block can be given as a single injection (single shot) or a continuous perineural infusion to extend the block's analgesic duration. It is unclear if the continuous infusion is superior to the single shot. Indeed, a high catheter dislodgement rate is observed for this location and local anesthetics could migrate into the femoral canal, resulting in quadriceps weakness. Alternatively, adequate postoperative analgesia has been shown effective with a single shot adductor canal block combined with extended release opioids.

The primary objective in this study is to compare two analgesic protocols on the pain score at walk 24 hours after total knee arthroplasty.

Here are the two protocols compared :

  1. Adductor canal block followed by continuous perineural perfusion for 48 hours
  2. Adductor canal block (single shot) followed by hydromorphone extended release formulation for 48 hours In addition to analgesic adjuvants administered in both groups : acetaminophen, celecoxib, pregabalin, dexamethasone and periarticular infiltration.

Our hypothesis is that both protocols ensure a similar analgesia.

详细描述

The improvement of postoperative analgesia is an important issue in orthopedic surgery, especially after total knee arthroplasty. The early postoperative mobilization of these patients is crucial to ensure a favorable functional evolution, and this goal can't be accomplished without effective analgesia. Opioids offer an efficient pain relief, but their consumption can result in side effects that can increase the length of hospital stay. The use of a peripheral nerve block, such as the adductor canal block (BCA) is a widely favored alternative since it allows postoperative analgesia superior to opioids while preserving the strength of the quadriceps.

For a long period of time, the femoral block has been the most popular peripheral nerve block for patients after a knee arthroplasty. However, this perineural block is associated with an important rate of quadriceps' weakness, which could impair the post-operative mobilization and expose the patient to a risk of falling. It has now been widely replaced by the adductor canal block. The latter has the advantage of providing analgesia at rest and during movement equivalent to the femoral block, while preserving the quadriceps strength and offering a better mobility in the first 24 hours after surgery. In opposition to the femoral block, the adductor canal block does not increase the risk of falling since it is mainly a sensitive block.

The adductor canal block is an advantageous analgesic modality for patients after TKA, but it is limited since it offers only analgesia to the anteromedial aspect of the knee, sparing the lateral and posterior faces. It is common to combine this block with a periarticular knee infiltration with local anesthetics, performed by the surgical team at the end of the surgery. The two modalities combined make it possible to achieve very low pains scores at rest and during walking, compared to both techniques used separately.

The adductor canal block can be administered in one unique injection or with a perineural continuous infusion, to extend the block's analgesic duration. However, it is uncertain whether there is an advantage to use a continuous infusion. There is a significant rate of catheter migrating out of the adductor canal and losing effect. There is also the possibility that the continuous infusion results in a proximal extent of local anesthetic in the femoral canal, generating quadriceps weakness that invalidates the benefits for ACB in the context of postoperative mobilization.

Indeed, the location of the catheter near the surgical site predisposes it to be dislodged out of the adductor canal during surgical manipulations in a significant proportion of patients. A rate as high as 30% of catheter dislodgement on postoperative day 1 was observed. It is possible to perform the block after surgery, before the dressing is applied, but this practice tends to create delays, which are not desirable in the actual context of optimization of the OR time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Participants won't know their group because this study will use a double placebo:

Group U: placebo for extended release hydromorphone (4 doses) Group C: sham perineurial infusion for 48h in group C (Perineurial catheter is connected to perineurial infusion pump but not infusion) Perineural infusion pumps will be covered with an opaque plastic bag to ensure blinding for patients and care providers Nurses and anesthesiologist and physiotherapist will be blinded to patient group allocation Investigator and outcome assessor will be blinded to group allocation

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-80 years old
  • American Society of Anesthesiology physical status I-III
  • Primary total knee arthroplasty surgery under regional anesthesia

排除标准

  • Chronic kidney disease (CKD) with eGFR < 60mL/min
  • Contraindications for the use of spinal anesthesia or adductor canal block : infection, sepsis, evolutive neurological disease, coagulopathy, patient refusal.
  • Chronic use of opioids (>30 mg daily morphine equivalent)
  • Documented allergy to Hydromorphone, tramadol, celecoxib, ropivacaine, pregabalin, acetaminophen and/or ketorolac
  • Patient weight < 50 kg or BMI > 40
  • Severe cardiac disease
  • Severe pulmonary disease
  • Chronic use of monoamine oxydase inhibitors
  • Pregnancy
  • Inability to give informed consent
  • Patient refusal

研究组 & 干预措施

Group C

Active Comparator

Adductor canal block performed in the pre-operative period with 20 mL of Ropivacaïne 0.5%, followed with a continuous perineural infusion of Ropivacaïne 0.2%, 5 ml/h for 48 hours via a perineural catheter.

They will also receive a placebo of Hydromorph Contin 3 mg, administered twice daily for 48h, starting on the evening after surgery

干预措施: Continuous perineural infusion of ropivacaine 0.2% 5 ml/h for 48 h (Drug)

Group U

Active Comparator

Adductor canal block performed in the pre-operative period with 30 mL of Ropivacaïne 0.5%. A catheter is inserted in the adductor canal but no perineurial infusion. The catheter is connected to a pump that is shut down.

They will also receive Hydromorph Contin 3 mg PO administered twice daily for 48 h, starting on the evening after surgery. 4 doses total

干预措施: Extended Release Capsule (Drug)

结局指标

主要结局

Pain score during walking (24 hours)

时间窗: 24 hours postoperatively

Verbal Numeric Scale pain score (0-10, where 0= no pain and 10= worst conceivable pain) during walking

次要结局

  • Pain score at rest (24 hours)(24 hours postoperatively)
  • QoR-40 (48 hours)(48 hours postoperatively)
  • Pain score at rest (48 hours)(48 hours postoperatively)
  • 10 minutes walking test (48 hours)(48 hours postoperatively)
  • Incidence of Postoperative Vomiting (24 hours)(24 hours postoperatively)
  • Incidence of Postoperative Nausea (48 hours)(48 hours postoperatively)
  • Pain score at knee flexion (48 hours)(48 hours postoperatively)
  • Degree of knee flexion (24 hours)(24 hours postoperatively)
  • 10 minutes walking test (24 hours)(24 hours postoperatively)
  • Incidence of Postoperative Vomiting (48 hours)(48 hours postoperatively)
  • sedation score(24 hours)(24 hours postoperatively)
  • Pain score during walking (48 hours)(48 hours postoperatively)
  • Pain score at knee flexion (24 hours)(24 hours postoperatively)
  • Degree of knee flexion (48 hours)(48 hours postoperatively)
  • Incidence of Postoperative Nausea (24 hours)(24 hours postoperatively)
  • sedation (48 hours)(48 hours postoperatively)
  • Cumulative opioïd dose (24 hours)(24 hours postoperatively)
  • Cumulative opioïd dose (48 hours)(48 hours postoperatively)

研究者

发起方
Ciusss de L'Est de l'Île de Montréal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Veronique Brulotte

Principal investigator

Maisonneuve-Rosemont Hospital

研究点 (1)

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