Effect of Different Truncal Blocks Under Ultrasound-Guidance on Pain Management After Open Reduction of Pediatric Developmental Dysplasia of the Hip: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change of FLACC pain scores at different time points (at rest and at movement)
研究概览
简要总结
The aim of the study is to evaluate the effectiveness of ultrasound-guided transversalis fascia plane block (TFPB) and quadratus lumborum block (QLB) on post-operative analgesia in pediatric patients with Developmental Dysplasia of the Hip (DDH)under going open reduction surgeries(Salter acetabular osteotomy,combined with proximal femoral rotation osteotomy).The effectiveness of TFPB/QLB for perioperative analgesia in lumbar nerves (L1) innervated surgery have been demonstrated in recent studies. However, this regional technique rarely applied to children.The objective of our research is to assess the quality of postoperative analgesia in pediatric patients who had received a preoperative TFPB/QLB for hip surgery.
详细描述
90 pediatric patients(age 2-10years) in the BeiJing Ji Shui Tan Hospital and The Second Affiliated Hospital of Wen Zhou Medical University with American Society of Anesthesiologists (ASA) physical status I or II, who are scheduled to undergo open reduction surgeries (Salter acetabular osteotomy,combined with proximal femoral rotation osteotomy)are selected and divided into 3 equal groups with 30 subjects.The consent forms are approved by the institutional Ethics Committee.
Inclusion Criteria: Pediatric patients between 2 years to 10 years with DDH, scheduled for unilateral open reduction surgeries(Salter acetabular osteotomy,combined with proximal femoral rotation osteotomy).
Exclusion Criteria:Patients will be excluded if participants meet any of the following criteria:patients with known allergy to local anaesthetics, mental disability, peripheral neuropathy, a coagulopathy disorder,localized infection in the area, and any reason cause reoperation.
Electrocardiogram, non-invasive blood pressure, pulse oximetry, temperature,capnography, and end tidal anesthetic concentration values are monitored in patients Parental presence will be allowed if requested for the induction of anesthesia. Pediatrics without vein access will receive general anesthesia which induces with 8% sevoflurane in 70% nitrous oxide and 30% oxygen, via a facemask. When loss of consciousness is achieved,investigators need to establish vein access routinely.Intravenous induction for general anesthesia with endotracheal intubation is commenced using intravenous propofol 3 mg/kg, cis-atracurium 0.2 mg/kg,fentanyl 2. ug/kg. Anesthesia will be maintained using remifentanyl, and a volatile anesthetic(sevoflurane). The inhaled concentration of sevoflurane will be adjusted to maintain hemodynamic stability, which is defined as a change in systolic blood pressure and heart rate of no more than 20% of baseline parameters. The use of opioids during the perioperative periods at the discretion of the anesthetist. Some anesthetists administer opioids preemptively, however, in the majority of cases the decision is based on the cardiovascular response to stimulation; an increase in heart rate of 10% from baseline is usually interpreted as insufficient analgesia and is treated with opioids. Patients will be given either fentanyl in doses of 1-2mcg/kg, remifentanil as continuous infusion 0.01-0.03 mcg/ (kg.min) or a combination of these.
TFPB group Patients in transversalis fascia plane block group(Group T) will receive ultrasound-guided transversalis fascia plane block using0.3% ropivacaine(0.8 ml/kg) after general anesthesia. A high-frequency probe (Sono-Site HFL50x, 15- 6 MHz, 55-mm broadband linear array) connected to an S-nerve ultrasound machine((Sonosite Inc,Bothell, WA, USA) was positioned with a transverse orientation, between iliac crest and costal margin.With the patient in a supine position, the needle is advanced from the anterior using an in-plane technique. A linear ultrasound probe is orientated transversely over the lateral abdomen between the iliac crest and the costal margin. The external oblique, internal oblique,and transversus abdominis muscles are imaged, and the more posterior transversus aponeurosis is isolated from these muscles.The reflection of the peritoneum curving away from the muscles from anterior to posterior, and the perinephric fat, which lies behind the peritoneum and deep to the transversalis fascia, are both identified. The perinephric fat is generally more prominent closer to the iliac crest. The quadratus lumborum is identified medial to the aponeurosis of the transversus abdominis. The end point is more visible if the needle is passed through the posterior''tail'' of the transversus muscle, as the transversus aponeurosis is thinner and less distinct as a separate layer. After passing through the deep surface of transversus abdominis muscle, local anesthetic is injected to separate the transversalis fascia from the transversus muscle. The correct needle position was confirmed by injection of 2 ml of normal saline solution that was spreading anterio-posteriorly between the anterior border of QLM and its fascia, in addition to a minimal anterior spread in TAP plane. After negative aspiration, 0.8 ml/Kg of ropivacaine 0.3%was injected.
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
- 2 Years 至 10 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged between 2 years and 10 years with DDH,
- •scheduled for unilateral open reduction surgeries(Salter acetabular osteotomy,combined with proximal femoral rotation osteotomy)
排除标准
- •Patients will be excluded if they meet any of the following criteria:
- •patients with known allergy to local anaesthetics,
- •mental disability,
- •peripheral neuropathy,
- •a coagulopathy disorder,
- •localized infection in the area,
- •any reason cause reoperation.
结局指标
主要结局
Change of FLACC pain scores at different time points (at rest and at movement)
时间窗: for the first 48 post-operative hours(at PACU, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 48 hours after surgery),the analgesic effects of patients at different times need to be evaluated, both at rest and at movement
using age-appropriate and validated tools (ie, the Face, Legs, Activity, Consolability Scale \[FLACC\] which evaluates the intensity of pain, ranged from 0-10, 0 means no pain and 10 means severe pain) to evaluate the change of pain scores at different time points which indirectly reflect the analgesia effect, both at rest and at movement.
次要结局
- PACU fentanyl consumptions(the time of staying in postanesthesia care unit(PACU), about 30 minutes to 60 minutes after surgery)
- Parental satisfaction score (0-10)(at 48 post-operative hours, when removed the NCA/PCA pump)
- The analgesia effects(for the first 48 post-operative hours)
- the rescue analgesics(for the first 48 post-operative hours)
- complications(for the first 48 post-operative hours)
- Intra-operative opioid consumptions(during the surgery, average 3 hours)
- PACU stay(the time of staying in post-anesthesia care unit(PACU), about 30 minutes to 60 minutes after surgery)
- PACU fentanyl rate(the time of staying in post-anesthesia care unit(PACU), about 30 minutes to 60 minutes after surgery)
- Hospital stay(the time of staying in hospital, average 12 days)
研究者
congcong huang
Department of Anesthesiology
Second Affiliated Hospital of Wenzhou Medical University
