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Quadroiliac Plane Block for Analgesia After Renal Transplantation

2026年7月29日 更新者:Engin Ihsan Turan、Kanuni Sultan Suleyman Training and Research Hospital

Analgesic Efficacy of Ultrasound-Guided Quadroiliac Plane Block Versus Surgical Wound Infiltration in Patients Undergoing Renal Transplantation: A Prospective, Randomized, Double-Blind, Controlled Clinical Trial

Renal transplantation is a major abdominal surgical procedure that may cause moderate to severe postoperative pain. Opioids are commonly used as part of multimodal analgesia; however, opioid-related adverse effects such as sedation, respiratory depression, nausea, vomiting, and constipation may delay recovery and mobilization.

The quadroiliac plane block is an ultrasound-guided interfascial plane block performed near the attachment of the quadratus lumborum muscle to the iliac crest. The technique may provide analgesia over a broad lower abdominal area and may reduce postoperative opioid requirements.

This prospective, randomized, double-blind, controlled clinical trial will compare an ultrasound-guided unilateral quadroiliac plane block with surgical wound infiltration in adult patients undergoing renal transplantation. Participants will be randomly assigned to receive either a quadroiliac plane block with 40 mL of 0.25% bupivacaine or surgical wound infiltration with 10 mL of 0.25% bupivacaine.

All participants will receive standardized multimodal analgesia and intravenous patient-controlled analgesia with tramadol. The primary objective is to compare cumulative tramadol consumption during the first 24 hours after surgery. Postoperative pain scores, dermatomal sensory distribution, motor block, nausea, vomiting, sedation, and quality of recovery will also be evaluated.

調査の概要

詳細な説明

This study is designed as a prospective, randomized, double-blind, parallel-group, controlled clinical trial involving adult patients undergoing renal transplantation.

Eligible participants will be randomly assigned in a 1:1 ratio to either the quadroiliac plane block group or the surgical wound infiltration group. A computer-generated block-randomization sequence will be used. Treatment assignments will be concealed in sequentially prepared, sealed envelopes and managed by a study team member who is not involved in postoperative outcome assessment.

Participants and postoperative outcome assessors will be masked to group allocation. The anesthesiologist performing the assigned intervention will be aware of the allocation but will not participate in postoperative data collection. The intervention will be performed while the participant remains anesthetized.

Quadroiliac Plane Block Group Participants assigned to the experimental group will receive an ultrasound-guided unilateral quadroiliac plane block on the surgical side. The participant will be placed in the lateral decubitus position. A low-frequency curvilinear ultrasound transducer will be positioned immediately above the posterior superior iliac spine and oriented parallel to the vertebral column.

The quadratus lumborum muscle, its attachment to the iliac crest, and the erector spinae muscle will be identified. A 22-gauge, 80-mm echogenic block needle will be advanced using an in-plane approach toward the fascial plane between the quadratus lumborum and erector spinae muscles. After confirmation of the target plane by hydrodissection and negative aspiration, 40 mL of 0.25% bupivacaine will be administered.

Surgical Wound Infiltration Group Participants assigned to the active-comparator group will receive surgical wound infiltration after completion of surgical closure. A total of 10 mL of 0.25% bupivacaine will be administered along the surgical incision into the subcutaneous tissues using an evenly distributed infiltration technique.

Standardized Postoperative Analgesia

At the end of surgery, all participants will receive the following intravenous medications:

Tramadol 100 mg Paracetamol 1 g Dexketoprofen 50 mg Postoperatively, intravenous paracetamol 1 g will be administered three times daily.

Intravenous patient-controlled analgesia will be provided using tramadol at a concentration of 3 mg/mL. The device will be programmed to deliver a 20 mg patient-initiated bolus with a 15-minute lockout interval and without a background infusion.

Outcome Assessments Postoperative pain intensity will be evaluated using an 11-point Numerical Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be assessed both at rest and during movement at postoperative hours 0, 1, 6, 12, and 24.

The primary outcome will be cumulative tramadol consumption recorded by the patient-controlled analgesia device during the first 24 postoperative hours.

The sensory distribution of the quadroiliac plane block will be assessed at postoperative hour 2 using a cold sensation test with an ice cube. Relevant abdominal dermatomes will be evaluated, and areas with reduced or absent cold sensation will be recorded.

Postoperative motor function will be evaluated at predefined assessment times. The presence of nausea, vomiting, and sedation will also be recorded during the first 24 postoperative hours.

Quality of postoperative recovery will be evaluated using the Quality of Recovery-11 questionnaire at postoperative hour 24.

The study aims to determine whether the ultrasound-guided quadroiliac plane block reduces postoperative tramadol consumption and improves analgesia and recovery compared with surgical wound infiltration in patients undergoing renal transplantation.

研究の種類

介入

入学 (推定)

60

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

  • 名前:Engin ihsan Turan, principal investigator
  • 電話番号:+905382431114
  • メール:enginihsan@hotmail.com

研究場所

    • Istanbul
      • Istanbul、Istanbul、トルコ(Türkiye)、34303
        • 募集
        • Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
        • 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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Age between 18 and 80 years
  • American Society of Anesthesiologists physical status I-III
  • Scheduled to undergo renal transplantation surgery
  • Ability to understand the study procedures and postoperative assessments
  • Provision of written informed consent

Exclusion Criteria:

  • Known allergy to bupivacaine or other amide-type local anesthetics
  • Infection at the planned injection site
  • Coagulopathy or anticoagulant therapy associated with an unacceptable bleeding risk for regional anesthesia
  • Sepsis
  • Severe spinal deformity or anatomical abnormality preventing performance of the quadroiliac plane block
  • Inability to cooperate or communicate reliably
  • Cognitive impairment or intellectual disability preventing informed consent or reliable outcome assessment
  • Altered level of consciousness
  • Breastfeeding
  • Refusal to participate

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:ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的:Quadro-Iliac Plane Block Group
Participants assigned to this group will receive an ultrasound-guided unilateral quadroiliac plane block on the surgical side while under general anesthesia. The block will be performed using 40 mL of 0.25% bupivacaine. All participants will receive the same standardized multimodal analgesic regimen and postoperative intravenous patient-controlled analgesia with tramadol.
With the participant in the lateral decubitus position, a low-frequency curvilinear ultrasound transducer will be positioned immediately above the posterior superior iliac spine and oriented parallel to the vertebral column. The quadratus lumborum muscle, its attachment to the iliac crest, and the erector spinae muscle will be identified. A 22-gauge, 80-mm echogenic needle will be advanced using an in-plane approach into the fascial plane between the quadratus lumborum and erector spinae muscles. After confirmation of the target plane by hydrodissection and negative aspiration, 40 mL of 0.25% bupivacaine will be administered on the surgical side.
アクティブコンパレータ:Surgical Wound Infiltration Group
Participants assigned to this group will receive surgical wound infiltration at the end of surgery. A total of 10 mL of 0.25% bupivacaine will be infiltrated into the subcutaneous tissues along the surgical incision. All participants will receive the same standardized multimodal analgesic regimen and postoperative intravenous patient-controlled analgesia with tramadol.
Following completion of surgical closure, a total of 10 mL of 0.25% bupivacaine will be infiltrated evenly into the subcutaneous tissues along the surgical incision. The infiltration will be performed using a standardized technique before the participant emerges from general anesthesia.

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
Cumulative Tramadol Consumption During the First 24 Postoperative Hours
時間枠:During the first 24 postoperative hours
The total amount of tramadol delivered by the patient-controlled analgesia device will be recorded in milligrams.
During the first 24 postoperative hours

二次結果の測定

結果測定
メジャーの説明
時間枠
Postoperative Pain Scores at Rest
時間枠:At postoperative hours 0, 1, 6, 12, and 24
Pain at rest will be assessed using an 11-point Numerical Rating Scale ranging from 0, no pain, to 10, the worst imaginable pain.
At postoperative hours 0, 1, 6, 12, and 24
Postoperative Pain Scores During Movement
時間枠:At postoperative hours 0, 1, 6, 12, and 24
Pain during movement will be assessed using an 11-point Numerical Rating Scale ranging from 0, no pain, to 10, the worst imaginable pain.
At postoperative hours 0, 1, 6, 12, and 24
Incidence of Postoperative Nausea and Vomiting
時間枠:During the first 24 postoperative hours
The number and proportion of participants experiencing nausea, vomiting, or both will be recorded.
During the first 24 postoperative hours
Quality of Recovery-11 Score
時間枠:At postoperative hour 24
Postoperative recovery and patient satisfaction will be assessed using the Quality of Recovery-11 questionnaire. Higher scores indicate better postoperative recovery.
At postoperative hour 24
Dermatomal Distribution Assessed by Cold Sensation
時間枠:At postoperative hour 2
The abdominal dermatomes showing changed or absent cold sensation will be assessed using an ice-cube test.
At postoperative hour 2

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。

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20日

一次修了 (推定)

2027年7月20日

研究の完了 (推定)

2027年7月21日

試験登録日

最初に提出

2026年7月16日

QC基準を満たした最初の提出物

2026年7月16日

最初の投稿 (実際)

2026年7月21日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月30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29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

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?

未定

IPD プランの説明

A final decision regarding the sharing of de-identified individual participant data has not yet been made. The decision will be made after completion of the study and publication of the primary results, taking into consideration participant confidentiality, ethics committee requirements, institutional policies, and applicable data protection regulations.

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