Single Shot Lumbar Erector Spinae Plane (ESP) Block in Total Hip Replacement (THR)
キーワード
概要
説明
After a pilot study regarding opioid use for patient after THR, the sample size for either treatment or control arm is calculated to be 35 patients per group to achieve adequate power to detect such a difference.
Sealed opaque envelopes with allocation inside is prepared forehand and is subsequently drawn on the day of surgery. The attending anaesthetist receives the envelope right before induction, and opens the envelope after the patient is put under general anaesthesia (GA). If the operation is cancelled or the patient cannot use PCA post-operatively (e.g. post-operative mechanical ventilation) or post-operative delirium), the envelope is put back into the pool.
After the patient is put under GA and turned lateral, the envelope is opened. For the treatment arm, lumbar ESP block is performed while for control arm no regional anaesthesia is performed nor saline is injected into the ESP. Before proceeding to ESP block, the back is cleaned with aseptic technique and draped. 40 mL of 0.25% levobupivacaine (or maximum of 2mg/kg body weight made up to same volume) is injected into the ESP.
After the injection, the surgeon is told not to infiltrate any local anaesthetics into the incision site or the wound. Intra-operatively, intravenous fentanyl is given as the only analgesic by the attending anaesthetist. Post-operatively, the patient is given fentanyl PCA of standard setting anaesthetist). Oral paracetamol of 15mg/kg (maximum 1g) is given four times a day post-operatively, while other adjuvant like NSAID and gabapentinoid are not prescribed for the time being.
The patient is assessed by an independent assessor from the acute pain service team 24 hours after the operation, who is blinded from the allocation result. Primary outcomes, that are post-operative 24 hour PCA fentanyl use and pain score in numeric rating scale (NRS) from 0 to 10 at rest and upon mobilisation are assessed and documented in the electronic system and also the patient chart. Secondary outcomes like presence/absence of PONV and knee flexion power in MRC scale are also noted.
The data are collected by the investigator and input to Excel 2003. 2-sided student's t test is used to compare the primary outcomes and also knee flexion power between treatment group and control group, while the rate of PONV between two groups is compared by Chi-square test.
日付
| 最終確認済み: | 04/30/2020 |
| 最初に提出された: | 05/08/2020 |
| 提出された推定登録数: | 05/10/2020 |
| 最初の投稿: | 05/13/2020 |
| 最終更新が送信されました: | 05/15/2020 |
| 最終更新日: | 05/18/2020 |
| 実際の研究開始日: | 04/30/2020 |
| 一次完了予定日: | 09/30/2022 |
| 研究完了予定日: | 09/30/2022 |
状態または病気
介入/治療
Procedure: Treatment
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: Treatment lumbar ESP block is performed. Before proceeding to ESP block, the back is cleaned with aseptic technique and draped. 40 mL of 0.25% levobupivacaine (or maximum of 2mg/kg body weight made up to same volume) is injected into the ESP. | Procedure: Treatment unilateral (operative side), performed at L1 level, under ultrasound guidance |
| No Intervention: Control no regional anaesthesia is performed nor saline is injected into the ESP |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - Adult patients (age >=18) - American Society of Anesthesiologists (ASA) class 1-3 - primary elective unilateral THR - understand and accept the risk for general anaesthesia and ESP block - counselled of post-operative patient controlled analgesia (PCA) and deemed fit for its use. Exclusion Criteria: - emergency THR - bilateral THR - revision THR - THR done under neuraxial technique (e.g. spinal anaesthesia, combined spinal epidural anaesthesia) - Patient with contraindication for ESP block (i.e. patient refusal, injection site infection or spine pathology/surgery, coagulopathy with international normalised ratio (INR) > 1.4 and thrombocytopenia < 75 x 10^9/L) - patient who are mentally incompetent - severe obesity (Body Mass Index >= 35) - severe obstructive sleep apnea syndrome (Apnoea hypopnoea index >= 30, no matter on treatment or not) |
結果
主な結果の測定
1. post-operative pain score in Numeric Rating Scale (NRS) from 0 (no pain) to 10 (extreme pain) [24 hour post-operatively]
2. post-operative 24 hour fentanyl (intravenous patient-controlled analgesia) use [24 hour post-operatively]
二次的な結果の測定
1. Post-operative nausea and vomiting (PONV) [24 hour post-operatively]
2. knee flexion power (operative side) [24 hour post-operatively]
