Comparison of the Analgesic Effect of an ACB (Adductor Canal Block) Using a New Suture-method Catheter vs a Standard Perineural Catheter vs a Single Bolus: A Randomized, Blinded, Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Total opioid consumption
研究概览
简要总结
In this study we wish to investigate the analgesic effect of the administration of 0.2% ropivacaine for an adductor canal block as repeated boluses (20 ml every 8 hours) through a new suture-method catheter or a standard perineural catheter compared with a single bolus (20 ml), in patients following primary total knee arthroplasty.
详细描述
The aim of the study is to compare the clinical effects of three different administration forms for an ACB: repeated intermittent boluses through a Certa catheter (CC) versus repeated boluses through a standard catheter (through the needle) (SC) versus a single bolus (SB). Our dual hypothesis is that repeated boluses through a catheter (either Certa or standard catheter) reduces opioid consumption (primary outcome), as well as reduces pain scores, enhances ambulation and muscle strength compared with a single bolus, and that the Certa catheter is superior to a standard catheter.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Please see "Model Description"
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for unilateral total knee arthroplasty in spinal anesthesia
- •Patients who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and restrictions
- •Ability to perform a TUG test preoperatively
排除标准
- •Patients who cannot cooperate
- •Patients who cannot understand or speak Danish.
- •Patients with allergy to the medicines used in the study
- •Patients with a daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl) during the last 4 weeks
- •Patients suffering from alcohol and/or drug abuse - based on the investigator's assessment
- •Rheumatoid arthritis
- •BMI > 40
- •Neuromuscular pathology in the lower limbs
- •Pregnancy
研究组 & 干预措施
Certa Catheter
A Certa-catheter (suture method) is inserted under ultrasound guidance at the midthigh level in the adductor canal, using an in plane technique, short/oblique axis view.
A bolus of ropivacaine will be administered during real time US imaging to ensure correct placement of the catheter (initial bolus). An infusion pump will be connected immediately following catheter insertion, delivering intermittent boluses every 8 hours until 12 pm on POD2.
2 dressings will be applied (medial and lateral) to obscure which catheter has been placed.
干预措施: Initial bolus (Certa and standard catheter groups) (Drug)
Certa Catheter
A Certa-catheter (suture method) is inserted under ultrasound guidance at the midthigh level in the adductor canal, using an in plane technique, short/oblique axis view.
A bolus of ropivacaine will be administered during real time US imaging to ensure correct placement of the catheter (initial bolus). An infusion pump will be connected immediately following catheter insertion, delivering intermittent boluses every 8 hours until 12 pm on POD2.
2 dressings will be applied (medial and lateral) to obscure which catheter has been placed.
干预措施: Intermittent boluses (Certa and standard catheter groups) (Drug)
Standard Catheter
A Standard-catheter is inserted under ultrasound guidance at the midthigh level in the adductor canal, using an in plane technique, short/oblique axis view.
A bolus of ropivacaine will be administered during real time US imaging to ensure correct placement of the catheter (initial bolus). An infusion pump will be connected immediately following catheter insertion, delivering intermittent boluses every 8 hours until 12 pm on POD2.
2 dressings will be applied (medial and lateral) to obscure which catheter has been placed.
干预措施: Initial bolus (Certa and standard catheter groups) (Drug)
Standard Catheter
A Standard-catheter is inserted under ultrasound guidance at the midthigh level in the adductor canal, using an in plane technique, short/oblique axis view.
A bolus of ropivacaine will be administered during real time US imaging to ensure correct placement of the catheter (initial bolus). An infusion pump will be connected immediately following catheter insertion, delivering intermittent boluses every 8 hours until 12 pm on POD2.
2 dressings will be applied (medial and lateral) to obscure which catheter has been placed.
干预措施: Intermittent boluses (Certa and standard catheter groups) (Drug)
Single Bolus
A bolus of ropivacaine will be injected into the adductor canal, at the midthigh level, using a 80 mm x 22G Pajunk needle during real time US imaging (initial bolus).
A sham catheter (25 Certa and 25 standard catheters according to randomi-zation) will be fixed externally and covered by dressings as in the catheter groups groups (Certa and standard). Care will be taken to use approximately the same amount of time as used in the catheter groups (Certa and standard) An infusion pump will be connected immediately following catheter insertion, delivering intermittent boluses into the dressing every 8 hour until 12 PM on POD2.
干预措施: Initial bolus (Single bolus group) (Drug)
Single Bolus
A bolus of ropivacaine will be injected into the adductor canal, at the midthigh level, using a 80 mm x 22G Pajunk needle during real time US imaging (initial bolus).
A sham catheter (25 Certa and 25 standard catheters according to randomi-zation) will be fixed externally and covered by dressings as in the catheter groups groups (Certa and standard). Care will be taken to use approximately the same amount of time as used in the catheter groups (Certa and standard) An infusion pump will be connected immediately following catheter insertion, delivering intermittent boluses into the dressing every 8 hour until 12 PM on POD2.
干预措施: Intermittent boluses (Single bolus group) (Drug)
结局指标
主要结局
Total opioid consumption
时间窗: from end of surgery until 12 (noon) on POD 2 (Postoperative Day)
• Total opioid consumption (PCA pump and any potential rescue administration) between groups (SB vs CC, SB vs SC and CC vs SC)
次要结局
- VAS (Visual analog scale) flexion(o Pain is recorded preoperatively before administration of medication, and postoperatively at the PACU (Postoperative Care Unit), at 8 PM on the day of surgery, at 8 AM, 12 (noon) and 8 PM on POD 1 and finally at 8 AM and 12 (noon) on POD 2.)
- VAS rest(o Pain is recorded preoperatively before administration of medication, and postoperatively at the PACU, at 8 PM on the day of surgery, at 8 AM, 12 (noon) and 8 PM on POD 1 and finally at 8 AM and 12 (noon) on POD 2.)
- VAS-TUG (Time-Up-and-Go-Test)(12 (noon) on POD 1 and 2)
- TUG-test(12 (noon) on POD 1 and 2)
- 6 minutes walk test(12 (noon) on POD 1 and 2)
- MVIC (Maximum Voluntary Isometric Contraction)(Preoperatively and at 12 (noon) on POD 1 and 2)
- TUG test, patient number(12 (noon) on POD 1 and 2)
研究者
Ulrik Grevstad
MD, phd
University Hospital, Gentofte, Copenhagen