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Retrolaminar Plane Block Versus Anterior Quadratus Lumborum Block in Pediatric Urogenital Surgery

2026年7月14日 更新者:Münevver Kayhan、Istanbul University - Cerrahpasa

Comparison of the Postoperative Analgesic Efficacy of Retrolaminar Plane Block and Anterior Quadratus Lumborum Block in Pediatric Lower Urogenital Surgery: A Randomized Controlled Trial

Effective control of postoperative pain following pediatric lower urogenital surgery is important for enhancing recovery and reducing opioid requirements. Anterior quadratus lumborum block and retrolaminar block are two ultrasound-guided truncal block techniques used for perioperative analgesia in lower abdominal surgery. However, direct comparisons of their analgesic efficacy in pediatric lower urogenital procedures remain limited.

This prospective, randomized, controlled trial will enroll 76 pediatric patients aged 6 months to 12 years with American Society of Anesthesiologists physical status I-III who are scheduled for elective lower urogenital surgery. Participants will be randomly assigned in a 1:1 ratio to receive either an anterior quadratus lumborum block or a retrolaminar block. Both techniques will be performed under ultrasound guidance in addition to standardized general anesthesia.

The primary outcome will be rescue analgesic requirement during the first 24 postoperative hours. Secondary outcomes will include postoperative pain scores, time to first rescue analgesic administration, intraoperative remifentanil consumption, adverse effects such as nausea and vomiting, and caregiver satisfaction. The study aims to compare the postoperative analgesic efficacy and safety of anterior quadratus lumborum block and retrolaminar block in pediatric patients undergoing lower urogenital surgery.

調査の概要

詳細な説明

Effective postoperative pain control following pediatric lower urogenital surgery is essential for improving recovery, reducing distress, facilitating oral intake, and decreasing opioid consumption. Ultrasound-guided regional anesthesia techniques have become an important component of multimodal analgesia strategies in pediatric anesthesia. Anterior quadratus lumborum block and retrolaminar block are two truncal block techniques used to provide analgesia for lower abdominal surgical procedures. However, direct comparisons of the postoperative analgesic efficacy of these techniques in pediatric lower urogenital surgery remain limited.

The aim of this study is to compare the postoperative analgesic efficacy of anterior quadratus lumborum block and retrolaminar block in pediatric patients undergoing lower urogenital surgery. Secondary objectives include evaluation of rescue analgesic requirements, postoperative pain scores, time to first rescue analgesic administration, intraoperative opioid consumption, adverse effects, and caregiver satisfaction.

This study is designed as a prospective, randomized, controlled, assessor-blinded clinical trial involving pediatric patients aged 6 months to 12 years with American Society of Anesthesiologists physical status I to III who are scheduled for elective lower urogenital surgery. Eligible participants will be randomly assigned in a 1:1 ratio to either the anterior quadratus lumborum block group or the retrolaminar block group using a computer-generated randomization sequence. Allocation concealment will be maintained using sequentially numbered opaque sealed envelopes.

All patients will receive standardized general anesthesia. Following induction of anesthesia, regional blocks will be performed under sterile conditions with ultrasound guidance. In both groups, 0.25 percent bupivacaine will be administered at a volume of 0.4 milliliters per kilogram.

Intraoperative monitoring will include heart rate and arterial blood pressure measurements recorded at baseline and predefined time points during surgery. If either parameter increases by 20 percent or more compared with baseline values, remifentanil infusion will be initiated and total remifentanil consumption will be recorded.

Postoperative pain assessment will be performed using the Face, Legs, Activity, Cry, and Consolability Scale. This scale ranges from 0 to 10 points, with higher scores indicating greater pain intensity. Rescue analgesia will be administered when the score is 4 or higher.

Patients will be evaluated in the post-anesthesia care unit and during ward follow-up at predefined time points. Pain scores, total rescue analgesic consumption, time to first rescue analgesic administration, adverse events including postoperative nausea and vomiting, and caregiver satisfaction will be recorded.

The primary outcome measure is total rescue analgesic requirement during the first 24 postoperative hours. Secondary outcome measures include postoperative pain scores, time to first rescue analgesic administration, intraoperative remifentanil consumption, incidence of postoperative nausea and vomiting, block success, and caregiver satisfaction.

Based on the sample size calculation, a total of 76 patients will be enrolled. Statistical analyses will be performed using appropriate parametric or nonparametric methods, and a p value less than 0.05 will be considered statistically significant.

研究の種類

介入

入学 (推定)

76

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

  • 名前:Ayse Cigdem Tutuncu, Professor Doctor
  • 電話番号:02124143000
  • メール:actutuncu@gmail.com

研究場所

    • Istanbul
      • Bakırköy、Istanbul、トルコ(Türkiye)、34153
        • Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Age between 6 months and 12 years
  • Scheduled for lower abdominal urogenital surgery (e.g., inguinal hernia repair or orchiopexy for undescended testis)
  • American Society of Anesthesiologists physical status classification I-III
  • Written informed consent obtained from a parent or legal guardian

Exclusion Criteria:

  • History of allergy to local anesthetic agents
  • Presence of infection at the planned injection site
  • Coagulopathy or any other condition contraindicating regional anesthesia
  • Planned laparoscopic orchiopexy
  • American Society of Anesthesiologists physical status classification IV
  • Inability to obtain informed consent from a parent or legal guardian
  • Anticipated requirement for postoperative intensive care unit admission

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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:トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的:Anterior Quadratus Lumborum Block Group
Participants assigned to this group will receive an ultrasound-guided anterior quadratus lumborum block following induction of general anesthesia for postoperative analgesia. The block will be performed under sterile conditions using 0.25 percent bupivacaine at a volume of 0.4 milliliters per kilogram. Standardized general anesthesia and postoperative analgesic protocols will be applied to all participants.
An ultrasound-guided anterior quadratus lumborum block will be performed after induction of general anesthesia. Following identification of the quadratus lumborum and psoas major muscles, 0.25 percent bupivacaine will be injected into the fascial plane between these muscles at a volume of 0.4 milliliters per kilogram.
実験的:Retrolaminar Block Group
Participants assigned to this group will receive an ultrasound-guided retrolaminar block following induction of general anesthesia for postoperative analgesia. The block will be performed under sterile conditions using 0.25 percent bupivacaine at a volume of 0.4 milliliters per kilogram. Standardized general anesthesia and postoperative analgesic protocols will be applied to all participants.
An ultrasound-guided retrolaminar block will be performed after induction of general anesthesia. After identification of the target vertebral lamina, 0.25 percent bupivacaine will be administered into the retrolaminar plane at a volume of 0.4 milliliters per kilogram.

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
Total Rescue Analgesic Requirement During the First 24 Postoperative Hours
時間枠:First 24 hours after surgery
Total rescue analgesic consumption during the first 24 postoperative hours will be recorded. Pain assessment will be performed using the Face, Legs, Activity, Cry, and Consolability Scale. The scale ranges from 0 to 10, with higher scores indicating greater pain intensity. Rescue analgesia will be administered when the score is 4 or higher.
First 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
Postoperative Pain Scores
時間枠:Postoperative 1, 2, 4, 8, 16, and 24 hours
Pain intensity will be assessed using the Face, Legs, Activity, Cry, and Consolability Scale. Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Postoperative 1, 2, 4, 8, 16, and 24 hours
Time to First Rescue Analgesic Administration
時間枠:First 24 hours after surgery
The time from completion of surgery to the administration of the first rescue analgesic will be recorded in minutes.
First 24 hours after surgery
Intraoperative Remifentanil Consumption
時間枠:From induction of anesthesia until the end of surgery
Total remifentanil consumption during surgery will be recorded in micrograms per kilogram.
From induction of anesthesia until the end of surgery

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:münevver kayhan、Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
  • スタディディレクター:Ayse Cigdem Tutuncu, Professor Doctor、Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
  • スタディチェア:Pinar Kendigelen, Professor Doctor、Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月25日

一次修了 (推定)

2027年7月20日

研究の完了 (推定)

2027年9月1日

試験登録日

最初に提出

2026年7月14日

QC基準を満たした最初の提出物

2026年7月14日

最初の投稿 (実際)

2026年7月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月17日

QC基準を満たした最後の更新が送信されました

2026年7月14日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • ctf- rlb&antqlb

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

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