Posterior Quadratus Lumborum Block Using 0.125% Versus 0.25% Bupivacaine for Analgesia in Children Undergoing LPEC
Comparison of Analgesic Efficiency in Laparoscopic Percutaneous Extraperitoneal Closure for Pediatric Inguinal Hernia and Hydrocele Provided by Ultrasound Guided Posterior Quadratus Lumborum Block Using Between 0.125% and 0.25% Bupivacaine
調査の概要
詳細な説明
Fifty participants both male and female aged from 1 to 6 years old, AGED FROM 1 TO 6 YEARS OLD, ASA class I to II undergoing elective Laparoscopic percutaneous extraperitoneal closure for pediatric inguinal hernia and hydrocele will be randomly divided into two equal groups of twenty five by using computer generated random table.
All received premedication in the form of midazolam 0.1 mcg/kg IV. Perioperative monitoring included continuous ECG, NIBP and pulse oximetry. Baseline reading of these were recorded. General anesthesia will be inducted using thiopental 5 mg/kg then atracurium 0.5 mg/kg to facilitate endotracheal tube intubation and fentanyl 1 mcg/kg. Anesthesia will be maintained using 2% isoflurane with oxygen to air 40:60.
Posterior quadratus lumborum block (The technique which local anesthetic agent is injected at middle thoracolumbar fascia between erector spina muscle and quadratus lumborum muscle) provided by GE, LOGIQe VERSION (12L-RS, LINEAR ARRAY) ultrasound guided and using stimuplex needle 22G-2 inches on both sides under sterile technique in lateral position will be performed in all patients immediately after induction and before starting surgery. patients will be allocated randomly into two equal groups, twenty five in each as the following GROUP 1 will receive 0.25% bupivacaine 0.4 ml/kg. per each side. GROUP 2 will receive 0.125% bupivacaine 0.4 ml/kg. per each side. The patients and parents along with independent anesthesiologist and attending nurses were not aware of group allocation.
The surgical intervention was started not less than 10 minutes after block. Pneumoperitonium pressure was limited not exceed 10 mmHg. After completion of surgery, anesthesia was discontinued and muscle relaxant was reversed as usual. After extubation, the patients will be transfer to PACU.
Postoperative pain will be assessed by attending nurses, using CHEOPs SCORE. Acetaminophen 10 mg/kg. orally will be given as rescue analgesia for patient with CHEOPs SCORE more than 6. Parameters will be assessed
Intraoperative measurements:
- Hemodynamic parameters: HR and MAP were recorded before, immediately and every 5 minutes after induction of anesthesia until the end of the operation.
- Analgesic requirement: All through the procedure (By measure analgesic need intraoperative in the form of fentanyl 0.5 mcg/kg) In case of increase in intraoperative MAP or HR of more than 20% from baseline.
- Incidence of complications: In the form of hypotension, hematoma, intraabdominal organ injury LAST.
Postoperative measurements:
- Quality of analgesia: Assessed immediately postoperatively every 30 minutes in the PACU and then at 4, 8, 12 hours at ward using CHEOPs SCORE and 24 hours postoperatively using PARENT'S POSTOPERATIVE PAIN MEASUREMENT(PPPM).
- Incidence of complications: In the form assessment of intensity of motor block by using MODIFIED BROMAGE SCORE, vomiting and hemodynamic instability.
- Others: In the form of parent's satisfaction of analgesia and length of hospital stay.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：SUWITCHA TAMRONGCHOTE, MD
- 電話番号：+66989425629
- メール：S.NI.KTAMP@GMAIL.COM
研究連絡先のバックアップ
- 名前：NUTTAPHONG LEPANANON, MD
- 電話番号：+66850602800
- メール：N_PEDIAN@HOTMAIL.COM
研究場所
-
-
Bangkok
-
Ratchathewi、Bangkok、タイ、10400
- 募集
- Queen Sirikit National Institute of Child Health
-
コンタクト：
- Kullasate Sakpichaisakul, MD
- メール：kullasate.s@rsu.ac.th
-
コンタクト：
- Kantapon Trongkamolchai, MD
- メール：kantapon260619870@gmail.com
-
主任研究者：
- Kullasate Sakpichaisakul, MD
-
副調査官：
- Kantapon Trongkamolchai, MD
-
副調査官：
- Somjit Sri-udomkajorn, MD
-
副調査官：
- Sirorat Suwannachote, MD
-
副調査官：
- Ravivan Wittawassamrankul, R Ph
-
副調査官：
- Ravindra Arya, MD, DM
-
副調査官：
- Suwitcha Tamrongchote, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Children scheduled for laparoscopic percutaneous extraperitoneal closure(LPEC) for pediatric inguinal hernia and hydrocele
- ASA I-II physical status patients
- Complete inform consent for intervention
Exclusion Criteria:
- Contraindication for regional anesthesia
- Sensitive to local anesthetic agent, opioid or acetaminophen
- Previous history of abdominal surgery
- History of neuromuscular disease
- G6PD deficiency
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：ROUTINE DRUG - CONCENTRATION QLB
The patients will receive bilateral posterior quadratus lumborum block using 0.25% bupivacaine 0.4 ml/kg. in each side.
|
Analgesic efficiency comparison between two concentration of bupivacaine hydrochloride using for posterior quadratus lumborum block in LPEC
|
|
アクティブコンパレータ：ALTERNATIVE DRUG - CONCENTRATION QLB
The patients will receive bilateral posterior quadratus lumborum block using 0.125% bupivacaine 0.4 ml/kg. in each side.
|
Analgesic efficiency comparison between two concentration of bupivacaine hydrochloride using for posterior quadratus lumborum block in LPEC
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality of postoperative analgesia
時間枠：24 hours after surgery
|
Postoperative pain score as CHEOPs SCORE
|
24 hours after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of complications
時間枠：12 hours after surgery
|
Intensity of motor block by using MODIFIED BROMAGE SCORE, vomiting and hemodynamic instability
|
12 hours after surgery
|
協力者と研究者
捜査官
- 主任研究者：SUWITCHA TAMRONGCHOTE, MD、Queen Sirikit National Institute of Child Health (QSNICH)
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
術後の痛みの臨床試験
-
Bingol UniversityAtaturk Universityまだ募集していません術前不安 | 恐れ | PAİN
-
Dexa Medica Group完了
Bupivacaine hydrochlorideの臨床試験
-
Zhejiang Provincial People's HospitalShandong Suncadia Medicine Co., Ltd.募集
-
Tanta University完了デクスメデトミジン | 腹腔鏡下胆嚢摘出術 | 方形腰ブロック | 術後鎮痛 | ブピバカイン | 超音波ガイドエジプト
-
Kulsoom International Hospital募集
-
Allama Iqbal Teaching Hospital完了
-
Tanta University完了