Efficacy of Ultrasound-Guided Transversus Abdominis Plane Block for Postoperative Pain Control in Laparoscopic Cholecystectomy: Prospective Randomized Controlled Trial in Pediatric Patients
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- cumulative opioid consumption (both intravenous and enteral) during the perioperative period
研究概览
简要总结
Laparoscopic cholecystectomy is associated with considerable postoperative pain and surgeon-administered local anesthetic infiltration is the standard practice for achieving post-operative analgesia. However, recent studies have shown that pediatric patients continue to experience significant pain during the first 24 hours.
The investigators plan to conduct a prospective, double-blinded, randomized study where patients will be designated into either a test group receiving an ultrasound-guided transversus abdominis plane (TAP) and rectus sheath (RS) blocks with ropivacaine and peri-portal sterile saline or the control group that will receive ultrasound-guided TAP block with sterile saline and peri-portal infiltration of ropivacaine. The anesthesia team and surgical team will both be blinded as well as the research personal in the postoperative period. Patients age 5-17 and American Society of Anesthesiology status I and II undergoing laparoscopic cholecystectomy will be included.
The study hypothesis is that ultrasound-guided peripheral nerve blocks, specifically single shot transversus abdominis plane and rectus sheath blocks, are superior to local wound infiltration during laparoscopic cholecystectomy for decreasing postoperative pain and pain related behavior and facilitating functional recovery.
详细描述
Patients will be randomized into either a test group receiving an ultrasound-guided TAP block with ropivacaine and peri-portal sterile saline or the control group that will receive ultrasound-guided TAP block with sterile saline and peri-portal infiltration of ropivicaine. All patients, who are scheduled to undergo laparoscopic cholecystectomy who meet the inclusion/exclusion criteria, and their parent(s)/guardian(s) will be called by the study staff the afternoon before surgery, who will follow a study script introducing the project and providing them with an opportunity to enroll in this study or opt out. If the patient cannot be reached the day before surgery, they will be offered the opportunity to enroll the day of surgery in the pre-operative holding area. If the decision is made to participate in the study, a physician study investigator will obtain appropriate consent and assent when applicable. Recruitment materials will be provided, if desired. A copy of this consent form will be placed in the Boston Children's Hospital medical record and a separate research record.
Stratified randomization of patients will be conducted by the pharmacy to maintain the double-blinded nature of the study. The pharmacy staff will deliver a study syringe labeled "regional" and a study syringe labeled "local". Depending on randomization, the "regional" syringe will be filled with either ropivacaine 0.2% or normal saline to the corresponding volume based on the dosing outlined. Similarly, the local syringe will be filled with the opposite solution. Thus, if the "regional" syringe is filled with ropivacaine, the local syringe will be filled with normal saline, and vice versa.
Both surgical and anesthesia teams will be blind to the intervention received by the patient.
The patients will be divided into two groups: 1. Abdominal Wall Block with Ropivacaine and 2. Surgical infiltration with Ropivacaine.
The abdominal wall block group will receive: bilateral transversus abdominis plane and rectus sheath blocks via ultrasound guidance. A total of 1.0ml/kg distributed between the four blocks (0.4+0.4+0.1+0.1) of 0.2% Ropivacaine (max 50ml) will be injected, as a one time single shot injection, into the fours sites. Surgical infiltration of the four port sites will receive 0.4ml/kg of sterile saline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient age 5-17 years old at time of surgery
- •ASA status 1-2
- •Parent is able to provide informed consent and patient's > age 7 able to give assent
- •Patients scheduled for laparoscopic cholecystectomy
- •Surgery will involve and be limited to laparoscopic cholecystectomy
- •Admission status: 24-hour admission to hospital
排除标准
- •Non-English speaking parents/patient.
- •All emergency laparoscopic cholecystectomies or conversion to an open procedure
- •Patients who will remain intubated or require ICU care postoperatively
- •Significant liver or renal disease
- •Coagulopathy
- •Underlying neurocognitive disorder or developmental delay affecting ability to convey feelings of pain to medical staff
- •Diagnosis of chronic pain syndrome
- •Active infection over nerve block sites
- •History of allergy to local anesthetic agents or non-steroidal anti-inflammatory drugs (NSAIDS)
- •Known alcohol or substance abuse within the past 6 months
- •Daily Opioid use
- •ASA class 3 or higher
研究组 & 干预措施
Abdominal Wall Block with Ropivacaine 0.2%
Patients will receive bilateral transversus abdominis plane and rectus sheath blocks via ultrasound guidance. A total of 1.0ml/kg distributed between the four blocks (0.4+0.4+0.1+0.1) of 0.2% Ropivacaine (max 50ml) will be injected, as a one time single shot injection, into the fours sites. Surgical infiltration of the four port sites will receive 0.4ml/kg of sterile saline.
干预措施: Abdominal Wall Block (Procedure)
Abdominal Wall Block with Ropivacaine 0.2%
Patients will receive bilateral transversus abdominis plane and rectus sheath blocks via ultrasound guidance. A total of 1.0ml/kg distributed between the four blocks (0.4+0.4+0.1+0.1) of 0.2% Ropivacaine (max 50ml) will be injected, as a one time single shot injection, into the fours sites. Surgical infiltration of the four port sites will receive 0.4ml/kg of sterile saline.
干预措施: Surgical infiltration (Procedure)
Abdominal Wall Block with Ropivacaine 0.2%
Patients will receive bilateral transversus abdominis plane and rectus sheath blocks via ultrasound guidance. A total of 1.0ml/kg distributed between the four blocks (0.4+0.4+0.1+0.1) of 0.2% Ropivacaine (max 50ml) will be injected, as a one time single shot injection, into the fours sites. Surgical infiltration of the four port sites will receive 0.4ml/kg of sterile saline.
干预措施: Sterile saline (Drug)
Abdominal Wall Block with Ropivacaine 0.2%
Patients will receive bilateral transversus abdominis plane and rectus sheath blocks via ultrasound guidance. A total of 1.0ml/kg distributed between the four blocks (0.4+0.4+0.1+0.1) of 0.2% Ropivacaine (max 50ml) will be injected, as a one time single shot injection, into the fours sites. Surgical infiltration of the four port sites will receive 0.4ml/kg of sterile saline.
干预措施: Ropivacaine 0.2% (Drug)
Abdominal Wall Block with Ropivacaine 0.2%
Patients will receive bilateral transversus abdominis plane and rectus sheath blocks via ultrasound guidance. A total of 1.0ml/kg distributed between the four blocks (0.4+0.4+0.1+0.1) of 0.2% Ropivacaine (max 50ml) will be injected, as a one time single shot injection, into the fours sites. Surgical infiltration of the four port sites will receive 0.4ml/kg of sterile saline.
干预措施: Ultrasound (Device)
Surgical Infiltration with Ropivacaine 0.5%
Patients will receive surgical infiltration of local anesthetic into the 4 laparoscopic port sites. A total of 0.4 ml/kg (0.1+0.1+0.1+0.1) of 0.5% Ropivacaine, divided between the four port sites (max 20 ml), will be used. A total of 1ml/kg, divided between the TAP (0.4ml/kg on each side) and RS (0.1ml/kg on each side), of sterile saline will be used for the nerve blocks.
干预措施: Abdominal Wall Block (Procedure)
Surgical Infiltration with Ropivacaine 0.5%
Patients will receive surgical infiltration of local anesthetic into the 4 laparoscopic port sites. A total of 0.4 ml/kg (0.1+0.1+0.1+0.1) of 0.5% Ropivacaine, divided between the four port sites (max 20 ml), will be used. A total of 1ml/kg, divided between the TAP (0.4ml/kg on each side) and RS (0.1ml/kg on each side), of sterile saline will be used for the nerve blocks.
干预措施: Surgical infiltration (Procedure)
Surgical Infiltration with Ropivacaine 0.5%
Patients will receive surgical infiltration of local anesthetic into the 4 laparoscopic port sites. A total of 0.4 ml/kg (0.1+0.1+0.1+0.1) of 0.5% Ropivacaine, divided between the four port sites (max 20 ml), will be used. A total of 1ml/kg, divided between the TAP (0.4ml/kg on each side) and RS (0.1ml/kg on each side), of sterile saline will be used for the nerve blocks.
干预措施: Sterile saline (Drug)
Surgical Infiltration with Ropivacaine 0.5%
Patients will receive surgical infiltration of local anesthetic into the 4 laparoscopic port sites. A total of 0.4 ml/kg (0.1+0.1+0.1+0.1) of 0.5% Ropivacaine, divided between the four port sites (max 20 ml), will be used. A total of 1ml/kg, divided between the TAP (0.4ml/kg on each side) and RS (0.1ml/kg on each side), of sterile saline will be used for the nerve blocks.
干预措施: Ultrasound (Device)
Surgical Infiltration with Ropivacaine 0.5%
Patients will receive surgical infiltration of local anesthetic into the 4 laparoscopic port sites. A total of 0.4 ml/kg (0.1+0.1+0.1+0.1) of 0.5% Ropivacaine, divided between the four port sites (max 20 ml), will be used. A total of 1ml/kg, divided between the TAP (0.4ml/kg on each side) and RS (0.1ml/kg on each side), of sterile saline will be used for the nerve blocks.
干预措施: Ropivacaine 0.5% (Drug)
结局指标
主要结局
cumulative opioid consumption (both intravenous and enteral) during the perioperative period
时间窗: 24 hours
次要结局
- time to mobilization out of bed(24 hours)
- time to first liquid and/or solid PO intake(24 hours)
- overall patient functional recovery evidenced by validated patient surveys(24 hours)
- post-operative patient-reported pain scores upon arrival to the post-operative care unit and inpatient unit(every eight hours thereafter on the hospital floor for total of 24 hours postoperatively)
- post-operative episodes of opioid-related side effects, such as nausea, vomiting, constipation, urinary retention, and pruritis(24 hours)
研究者
Karen Boretsky
Dr. Karen Boretsky
Boston Children's Hospital