Comparison of the analgesic efficacy of ultrasound guided Sacral Erector Spinae Plane Block with ultrasound guided Caudal epidural Block in paediatric patients undergoing lower limb surgery under general anaesthesia: a randomised controlled study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Duration of post-operative analgesia is defined as the time after surgery within the first 24 hours at which Face, Leg, Activity, Cry and Consolability score (FLACC score) (a validated pain score) more than 4 or a verbal request of analgesics from verbal children.
研究概览
简要总结
Regional anesthesia is now recommended as an adjunct to general anesthesia whenever feasible for its opioid and anesthetic sparing effect. Caudal epidural block (CEB) is one of the most routinely practiced regional anesthetic procedures for intra and post-operative analgesia in paediatric patients. Although complications are rare, adverse effects reported include intravascular, subarachnoid or intraosseous space injection, hypotension (more common in adults), epidural hematoma as well as urinary retention. USG-guided ESPB is now a common regional anesthetic technique used in clinical practice for a variety of indications including breast reconstruction surgeries, lumbar spine fusion surgeries, post thoracotomy surgeries and hemorrhoidectomy surgeries. In paediatric patients it has shown effective pain control in hypospadias surgery, lower abdominal surgeries, hip surgeries and spine surgeries. It is considered a very safe block and very few adverse effects have been reported till date because the target area that is the vertebral transverse process is an avascular space and is away from all major vital structures and the neuraxis. The various approaches to the ESPB include thoracic, lumbar and sacral depending on the level of the target dermatomes. Sacral ESPB blocks lumbo-sacral dermatomes and is useful for lower abdominal and lower limb surgeries.
On extensive literature review, we could not find any study directly comparing sacral ESPB and caudal epidural block in pediatric patients undergoing lower limb surgery. Therefore, this study to compare sacral ESPB with caudal epidural block has been planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •The study will include all paediatric patients of age 1 years.
- •9 years, of either sex, ASA(American Society of Anesthesiologists classification of Physical Status) grade I and II undergoing elective or emergency lower limb surgery whose plan of anesthesia is decided as general anesthesia with a regional anesthesia technique.
排除标准
- •1.Contraindications to regional technique e.g. allergy to local anesthetic drugs, local site infection, sepsis, coagulation disturbance, anatomical abnormalities etc 2.Infants ( because of challenging blocks in this age group).
- •3.More than 9 years of age (due to the anatomical difficulties expected during caudal epidural block because of progressive ossification of sacrococcygeal ligament making the identification of the sacral hiatus difficult.) 4.Patient with neurological disorders 5.Patient with cutaneous anomalies (angioma, hair tuft, naevus , dimple at the site of block) 6.Inability to identify landmarks.
- •7.Patients on anti-epileptic drugs or any other enzyme inducers as that would affect the metabolism of the drug.
- •8.Hypersensitivity/contra-indication to any of the study drugs- local anesthetic or analgesic 9.Patients with polytrauma and patients with fractures of both upper and lower limb.
结局指标
主要结局
Duration of post-operative analgesia is defined as the time after surgery within the first 24 hours at which Face, Leg, Activity, Cry and Consolability score (FLACC score) (a validated pain score) more than 4 or a verbal request of analgesics from verbal children.
时间窗: T0 0 hour | T1 1 hour | T2 2 hours | T3 6 hours | T4 12 hours | T5 24 hours
次要结局
- 1.To assess & compare intraoperative opioid requirement in both the groups defined as total number of doses of fentanyl required.(2.To determine & compare the number & cumulative doses of rescue analgesics in the first 24 hours postoperatively.)