A Comparison of Lidocaine Versus Ropivacaine for Bilateral Continuous Thoracic Paravertebral Nerve Blocks for Post-bowel Surgery Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- 11-point Verbal Numerical Rating Scale (NRS) Pain Assessment
研究概览
简要总结
This research study is testing whether the local anesthetic lidocaine is as effective as ropivacaine for post-operative pain control in continuous thoracic paravertebral nerve blocks. Ropivacaine and Lidocaine are FDA-approved drugs that has been successfully used in this hospital for post-operative pain control for the past few years, thus has become the standard drugs used for this nerve block. Lidocaine has numerous potential advantages over ropivacaine, such as faster onset of action, better safety profile and greater anti-inflammatory action. Catheters placed near both sides of a patient's spine for postoperative pain control are called thoracic paravertebral nerve blocks and are a part of routine care. Through those catheters, a "numbing" medication, or local anesthetic, to block the transmission of pain from the surgical incision to the spinal cord, thus reducing pain. The research part of the study is whether subjects will receive either the local anesthetic lidocaine or ropivacaine. The goal of this study is to determine whether the lidocaine controls pain better and facilitates a faster recovery after abdominal surgery than ropivacaine.
In this research study, the investigators will compare patient-reported pain scores, any additional pain medication requirements for adequate pain control, time it takes for bowel function to return to normal following surgery, as well as the incidence of any side effects, such as numbness and weakness, subjects may experience between those receiving lidocaine versus those receiving ropivacaine. The investigators will screen 100 patients and enroll 60 subjects into this study.
详细描述
After determining eligibility, subjects will be enrolled in one of the two study groups on the day of surgery using a sealed envelope determined by a computer-generated list that made assignments randomly based on enrollment number. The study groups are defined as:
Study group: Lidocaine 0.25%(L) 32 patients Control group: Ropivacaine 0.2%(R) 32 patients
Paravertebral nerve block catheter placement and activation:
After standard monitors and supplemental oxygen are applied, the patient will be placed in a sitting position. The two points of needle entry will be marked on the skin corresponding to each of the bilateral paravertebral catheter placements. The thoracic spine level will be at the anatomic level corresponding to the midpoint of the incision as determined by the surgeon preoperatively (range T7 to T11). The needle entry sites will be 2.5 cm lateral on each side of the midpoint of the spinous process of the corresponding thoracic vertebrae. The area will be prepared and draped in a sterile fashion, and 1% lidocaine infiltrated subcutaneously at each point of anticipated needle entry. For each of the two catheter placements, a sterile 18 gauge Tuohy needle (B. Braun Medical, Inc., Perifix Continuous Epidural Anesthesia Set, Product Code CE18T) will be introduced perpendicularly to the skin until the transverse process is encountered, and the depth to the skin will be noted. The needle will then be readjusted in a caudad direction and inserted inferior to the corresponding transverse process to a depth approximately 1 cm deep to the transverse process. After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. Next 5 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through each catheter yielding a total activation dose of 15 ml of 0.5% Ropivacaine on each side. The catheters will be secured with Steri-strips and a transparent occlusive dressing. Vital signs will be monitored by the nurse at regular intervals until the patient is taken to the operating room.
Postoperative Management:
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)
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
- 否
入选标准
- •ASA I-III subjects
- •Ages 18-80 years
- •Weight between 60 and 110 Kg
- •At least 60in (152cm) tall
- •Scheduled for elective open colonic surgery at UPMC Presbyterian Shadyside Hospital in Pittsburgh, Pennsylvania
排除标准
- •Age younger than 18 years or older than 80 years
- •Any contraindication to the placement of bilateral thoracic paravertebral catheters
- •American Society of Anesthesiologists physical status IV or greater
- •Chronic painful conditions
- •Preoperative opioid use
- •Coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively
- •Allergy to any of the drugs/agents used study protocol
- •Personal or family history of malignant hyperthermia
- •Serum creatinine greater than 1.3 g/dl
- •Pregnancy
- •Having an altered mental status (not oriented to place, person, or time)
- •Emergency surgery and those with sepsis, unstable angina, congestive heart disease, valvular heart disease, and severe COPD
- •Patient's inability to provide adequate informed consent
- •Non-english speaking
- •Patient refusal
研究组 & 干预措施
Lidocaine
Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.
At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.
干预措施: Lidocaine (Drug)
Ropivacaine
Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.
Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
11-point Verbal Numerical Rating Scale (NRS) Pain Assessment
时间窗: 24 hours from the end of surgery
The primary outcome of the study is the NRS score for pain at rest at 24 hours. The NRS Pain Assessment requires patients to select a number between 0 - 10 where 0 is no pain and 10 is the worst imaginable pain. Patients pick one whole number on this scale to describe their pain.
次要结局
- Time to First Ambulation(Walking Greater Than 15 Feet)(During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery))
- Time to First Flatus/Defecation(During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery))
- Hospital Length of Stay.(During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery))
- Number of Patients With Complications (Including But Not Limited to Pneumonia, Atelectasis, Hypotension, Motor Weakness, Etc.)(During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery))
- Postoperative Opioid Consumption (Milligrams of Dilaudid or Equivalent)(During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery))
- Consumption of Nerve Block Boluses Will Also be Recorded Daily(During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery))
研究者
Jacques E. Chelly
Vice Chair of Clinical Research
University of Pittsburgh