Effects of Catheter Location on Postoperative Analgesia for Continuous Adductor Canal and Popliteal-Sciatic Nerve Blocks
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Pain (Average): Numeric Rating Scale for Pain
研究概览
简要总结
Currently, continuous adductor canal and popliteal-sciatic nerve blocks are used commonly for lower extremity post-operative pain control, specifically for total knee arthroplasty and foot/ankle surgery, respectively. A perineural catheter used to infuse local anesthetic for postoperative analgesia may be placed at various locations along the target nerves. Investigations of single-injection peripheral nerve blocks suggest that the onset of the block might be faster with one location over the other; but, the success rates are equivalent. However, remaining unknown is whether there is an optimal location to place a perineural catheter as part of a continuous peripheral nerve block.
详细描述
This will be a single-center (UCSD), randomized, controlled investigation.
Enrollment. Consenting adults undergoing knee arthroplasty or foot/ankle surgery with a planned adductor canal or popliteal perineural catheter, respectively, will be offered enrollment. Study inclusion will be proposed to eligible patients prior to surgery. If a patient desires study participation, written, informed consent will be obtained using a current UCSD IRB-approved ICF. Selection for inclusion will not be based on gender, race, or socioeconomic status. Inclusion and exclusion criteria are listed in section #10 below.
Following written, informed consent, The Investigators will record baseline anthropomorphic information (age, sex, height, and weight) that is already provided by all patients having surgery. All subjects will have a peripheral intravenous (IV) catheter inserted, standard noninvasive monitors applied, supplemental oxygen administered via a nasal cannula or face mask, and positioned supine (adductor canal) or prone (popliteal-sciatic). Midazolam and fentanyl (IV) will be titrated for patient comfort, while ensuring that patients remain responsive to verbal cues. The area that will be subsequently covered by the catheter dressing will be clipped of hair, if necessary. The ultrasound will be placed to visualize the short axis (cross-section) of the adductor canal or popliteal regional at both proximal and distal locations. If both sites are acceptable for catheter insertion, the subject will be randomized using a computer-generated list (blocks of 8) to one of two treatment groups in a 1:1 ratio using sealed, opaque, consecutively numbered envelopes stratified by catheter type (adductor canal vs. popliteal-sciatic): (1) proximal vs (2) distal insertion.
Catheter insertion. Catheter insertion will adhere to current UCSD standard-of-care. The only difference for subjects participating in the study (vs those not participating) will be that the specific catheter insertion location-both currently standard-of-care and used daily at UCSD because of clinical equipoise-will be determined randomly, instead of the physician simply choosing him/herself. All catheters will be placed by a regional anesthesia fellow or resident under the direct supervision and guidance of a regional anesthesia attending (or by the attending him/herself). All catheters will be placed using standard UCSD perineural catheter techniques, nerve in short-axis, ultrasound-guidance.
The area of insertion will be cleaned with chlorhexidine gluconate and isopropyl alcohol (ChloraPrep One-Step, Medi-Flex Hospital Products, Inc., Overland Park, KS, USA), and a clear, sterile, fenestrated drape applied. The ultrasound probe will be placed to visualize the short-axis (cross-section) of the target nerve(s). A skin wheal will be raised at the catheter-placement needle's anticipated point of entry (proximal or distal location). A 17 gauge needle (FlexTip, Teleflex Medical, Triangle Research Park, NC, USA) will be used to place all perineural catheters. The catheter-placement needle will be inserted through the skin wheal, advanced in-plane beneath the US transducer and directed to the target nerve as described below:
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
- Single (Participant)
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
- •undergoing surgery with an adductor canal or popliteal-sciatic perineural catheter for postoperative analgesia following primary tri-compartment knee arthroplasty or foot/ankle surgery;
- •anticipated to have at least moderate pain following surgery [NRS>3]; and,
- •age 18 years or older.
排除标准
- •pregnancy (a urine pregnancy test is standard at UCSD for female patients prior to menopause who are sexually active with the opposite sex within the previous year);
- •inability to communicate with the investigators and hospital staff;
- •clinical neuropathy in the surgical extremity;
- •chronic high-dose opioid use (defined as daily use for more than 4 weeks prior to surgery of at least the equivalent of 20 mg oxycodone);
- •BMI > 40 kg/m2;
- •allergy to study medications (lidocaine, ropivicaine);
- •known renal insufficiency; or,
- •incarceration.
研究组 & 干预措施
proximal catheter insertion
Adductor canal catheters: Inserted as described by Jæger et al., 2013: "...we performed an ultrasound survey at the medial part of the thigh, halfway between the superior anterior iliac spine and the [superior border of the] patella. In a short axis view, we identified the femoral artery underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery."
Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle will be inserted to intersect the sciatic nerve 6-7 cm proximal to the mark on the skin (therefore, proximal to the sciatic bifurcation) and injection with saline used to ensure subepimyseal spread.
干预措施: ropivacaine 0.2% (Drug)
distal catheter insertion
Adductor canal catheters: Inserted as described by Manickam et al. 2009
Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle tip will be inserted into the hypoechoic area between the two branches of the sciatic nerve immediately distal to the sciatic nerve bifurcation between the paraneurium and epineurium (the subparaneural space/compartment). As described by Tran et al, "An adequate position was defined as the presence of circular expansion of the paraneural sheath... Once circular expansion was obtained, we injected."
干预措施: ropivacaine 0.2% (Drug)
结局指标
主要结局
Pain (Average): Numeric Rating Scale for Pain
时间窗: Average for the day after surgery 08:00-24:00 (adductor) and the morning after surgery for 2 hours before phone call made between 10:00-noon (popliteal)
Numeric Rating Scale for Pain (0-10; 0=no pain and 10=worst imaginable pain)
次要结局
- Analgesic Use: IV Morphine Equivalents(Average for Intraoperative, in the recovery room, after the recovery room until 08:00 day after surgery, and 08:00-24:00 day after surgery)
- Ambulation: Distance in Meters(Average for morning and afternoon following surgery)
- Pain During Afternoon Physical Therapy Session(Average during physical therapy in the afternoon following surgery)
- Pain (Worst) :Numeric Rating Scale for Pain(Average for the day after surgery 08:00-24:00 (adductor) and the morning after surgery for 2 hours before phone call made between 10:00-noon (popliteal))
- Number of Participants That Had Fluid Leakage Reported at Catheter Site.(From surgery through the day after surgery)
- Total Local Anesthetic Infused (Adductor Only) : mL(The day following surgery recorded during mid-day rounds)
- Toe/Foot Numbness (Insensate) :0-10 Scale(Average for the morning after surgery for 2 hours before phone call made between 10:00-noon (popliteal only))
研究者
Brian M. Ilfeld, MD, MS
Professor of Anesthesiology, In Residence
University of California, San Diego