NCT03084536已完成2 期
PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Average Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year
研究概览
简要总结
In this double blinded randomized placebo-controlled trial, 160 subjects scheduled for breast surgery involving the axilla will be administered a multimodal pain regimen including acetaminophen, dexamethasone, celecoxib, and gabapentin. 80 subjects will also receive a Pectoral Nerve blocks I and II (PECS I and II block) preoperatively.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo elective breast cancer surgeries at Barnes-Jewish Hospital:
- •unilateral axillary dissection
- •unilateral modified radical mastectomy
- •mastectomy with same day unilateral reconstruction
- •unilateral sentinel lymph node biopsy (SLNB)
- •partial mastectomy with unilateral SLNB
- •simple mastectomy with unilateral SLNB
- •At least 18 years of age.
- •Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document.
- •Enrollment in the SATISFY-SOS study (WUSTL IRB# 201203088, NCT02032030).
排除标准
- •Planned for bilateral axillary or bilateral reconstruction surgery.
- •Previous surgery on the surgical breast and/or axilla with the exception of partial mastectomy or sentinel lymph node biopsy
- •Pre-existing pain in the axilla affecting the ability to use extremity for activities of daily living or requiring medication for treatment.
- •Current or past medical history of liver disease or cirrhosis with an elevated INR >1.4 or currently elevated transaminase levels.
- •Known contraindications to peripheral nerve block placement.
- •Pregnant or breastfeeding.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition
- •Planned additional surgery to the surgical breast or axilla in the next year (exception would be minor surgery to breast but not axilla such as simple tissue expander replacement or lumpectomy)
研究组 & 干预措施
Placebo PECS blocks
Placebo Comparator
- A sham block (normal saline) will be placed preoperatively
- To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number.
- Perioperative analgesic regimen will be encouraged. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative holding area. On the day of surgery all patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist.
干预措施: Gabapentin (Drug)
Preoperative PECS blocks
Active Comparator
- PECS I & II block will be administered preoperatively
- For unilateral surgeries, a PECS I block will be performed with 0.15mL/kg of 0.375% bupivacaine (maximum 10mL). The PECS II block will be performed with 0.3 mL/kg of the same solution (maximum 20mL). If there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side with 0.2mL/kg of 0.375% bupivacaine (maximum 20mL)
- To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number
- Perioperative analgesic will be encouraged.. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative area. All patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist
干预措施: Bupivacaine (Drug)
Preoperative PECS blocks
Active Comparator
- PECS I & II block will be administered preoperatively
- For unilateral surgeries, a PECS I block will be performed with 0.15mL/kg of 0.375% bupivacaine (maximum 10mL). The PECS II block will be performed with 0.3 mL/kg of the same solution (maximum 20mL). If there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side with 0.2mL/kg of 0.375% bupivacaine (maximum 20mL)
- To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number
- Perioperative analgesic will be encouraged.. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative area. All patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist
干预措施: Gabapentin (Drug)
Preoperative PECS blocks
Active Comparator
- PECS I & II block will be administered preoperatively
- For unilateral surgeries, a PECS I block will be performed with 0.15mL/kg of 0.375% bupivacaine (maximum 10mL). The PECS II block will be performed with 0.3 mL/kg of the same solution (maximum 20mL). If there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side with 0.2mL/kg of 0.375% bupivacaine (maximum 20mL)
- To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number
- Perioperative analgesic will be encouraged.. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative area. All patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist
干预措施: Celecoxib (Drug)
Preoperative PECS blocks
Active Comparator
- PECS I & II block will be administered preoperatively
- For unilateral surgeries, a PECS I block will be performed with 0.15mL/kg of 0.375% bupivacaine (maximum 10mL). The PECS II block will be performed with 0.3 mL/kg of the same solution (maximum 20mL). If there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side with 0.2mL/kg of 0.375% bupivacaine (maximum 20mL)
- To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number
- Perioperative analgesic will be encouraged.. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative area. All patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist
干预措施: Acetaminophen (Drug)
Preoperative PECS blocks
Active Comparator
- PECS I & II block will be administered preoperatively
- For unilateral surgeries, a PECS I block will be performed with 0.15mL/kg of 0.375% bupivacaine (maximum 10mL). The PECS II block will be performed with 0.3 mL/kg of the same solution (maximum 20mL). If there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side with 0.2mL/kg of 0.375% bupivacaine (maximum 20mL)
- To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number
- Perioperative analgesic will be encouraged.. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative area. All patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist
干预措施: Midazolam (Drug)
Preoperative PECS blocks
Active Comparator
- PECS I & II block will be administered preoperatively
- For unilateral surgeries, a PECS I block will be performed with 0.15mL/kg of 0.375% bupivacaine (maximum 10mL). The PECS II block will be performed with 0.3 mL/kg of the same solution (maximum 20mL). If there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side with 0.2mL/kg of 0.375% bupivacaine (maximum 20mL)
- To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number
- Perioperative analgesic will be encouraged.. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative area. All patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist
干预措施: Fentanyl (Drug)
Placebo PECS blocks
Placebo Comparator
- A sham block (normal saline) will be placed preoperatively
- To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number.
- Perioperative analgesic regimen will be encouraged. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative holding area. On the day of surgery all patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist.
干预措施: Celecoxib (Drug)
Placebo PECS blocks
Placebo Comparator
- A sham block (normal saline) will be placed preoperatively
- To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number.
- Perioperative analgesic regimen will be encouraged. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative holding area. On the day of surgery all patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist.
干预措施: Acetaminophen (Drug)
Placebo PECS blocks
Placebo Comparator
- A sham block (normal saline) will be placed preoperatively
- To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number.
- Perioperative analgesic regimen will be encouraged. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative holding area. On the day of surgery all patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist.
干预措施: Midazolam (Drug)
Placebo PECS blocks
Placebo Comparator
- A sham block (normal saline) will be placed preoperatively
- To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number.
- Perioperative analgesic regimen will be encouraged. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative holding area. On the day of surgery all patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist.
干预措施: Fentanyl (Drug)
结局指标
主要结局
Average Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year
时间窗: At 1 year
* The participant is asked to rate their pain by circling the one number that best describes their pain on the average. * 0=no pain and 10 = pain as bad as they can imagine. The higher number indicates worse pain.
Interference as Measured by the Brief Pain Inventory (BPI) at 1 Year
时间窗: At 1 year
* The participant is asked circle the one number that describes how much, during the past week pain has interfered with general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, sleep, and enjoyment of life. * 0=does not interference and 10 = completely interferes. The higher number indicates more interference from pain. * The scores for each subsection will be averaged.
Worst Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year
时间窗: At 1 year
* The participant is asked to rate their pain by circling the one number that best describes their pain at its worst in the past week. * 0=no pain and 10 = pain as bad as they can imagine. The higher number indicates worse pain.
次要结局
- Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Mental Health Summary Measure(At baseline and 1 year post-surgery)
- Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Physical Health Summary Measure(At baseline and 1 year post-surgery)
研究者
研究点 (1)
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