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Quadroiliac Plane Block for Analgesia After Renal Transplantation

2026년 7월 29일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Engin ihsan Turan, principal investigator
  • 전화번호: +905382431114
  • 이메일: enginihsan@hotmail.com

연구 장소

    • Istanbul
      • Istanbul, Istanbul, 터키 (Türkiye), 34303
        • 모병
        • Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
활성 비교기: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Cumulative Tramadol Consumption During the First 24 Postoperative Hours
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Postoperative Pain Scores at Rest
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 20일

기본 완료 (추정된)

2027년 7월 20일

연구 완료 (추정된)

2027년 7월 21일

연구 등록 날짜

최초 제출

2026년 7월 16일

QC 기준을 충족하는 최초 제출

2026년 7월 16일

처음 게시됨 (실제)

2026년 7월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 29일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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