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RIPB Versus EOIPB for Pain Control After Laparoscopic Cholecystectomy (RIPB-EOIPB)

2026년 5월 20일 업데이트: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Comparison of the Effects of Recto-Intercostal Plane Block and External Oblique Intercostal Plane Block on Postoperative Analgesia in Patients Undergoing Elective Laparoscopic Cholecystectomy

This prospective observational study aims to compare the effects of bilateral ultrasound-guided recto-intercostal plane block(RIPB) and bilateral ultrasound-guided external oblique intercostal plane block(EOIPB) on postoperative analgesia in patients undergoing elective laparoscopic cholecystectomy under general anesthesia.

Both blocks are performed after anesthesia induction as part of routine preemptive multimodal analgesia practice. Patients who receive bilateral recto-intercostal plane block will be included in the RIPB group, and patients who receive bilateral external oblique intercostal plane block will be included in the EOIPB group.

The primary outcome is cumulative intravenous tramadol consumption via patient-controlled analgesia during the first 24 postoperative hours. Secondary outcomes include postoperative pain scores at rest and during activity, rescue analgesic requirement, postoperative nausea and vomiting, time to mobilization, length of hospital stay, quality of recovery assessed using the Quality of Recovery-15 questionnaire, and block-related complications.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Laparoscopic cholecystectomy is one of the most commonly performed minimally invasive abdominal surgical procedures. Although it is associated with less postoperative pain and faster recovery compared with open surgery, postoperative pain may still occur due to trocar insertion, abdominal wall trauma, pneumoperitoneum-related peritoneal irritation, and visceral manipulation. Inadequate analgesia may delay mobilization, increase analgesic consumption, contribute to postoperative nausea and vomiting, and negatively affect postoperative recovery.

Ultrasound-guided fascial plane blocks are increasingly used as part of multimodal analgesia strategies for abdominal surgery. These techniques may reduce postoperative analgesic requirements by targeting the thoracoabdominal nerve branches that supply the abdominal wall. The recto-intercostal plane block and the external oblique intercostal plane block are two ultrasound-guided fascial plane blocks that may provide analgesia for the upper abdominal wall through different anatomical planes.

This study is designed as a prospective observational study in patients scheduled for elective laparoscopic cholecystectomy under general anesthesia. Patients will be included according to the regional analgesia technique performed as part of routine clinical practice. Patients receiving bilateral recto-intercostal plane block will form the RIPB group, while patients receiving bilateral external oblique intercostal plane block will form the EOIPB group. Both blocks will be performed after anesthesia induction as part of a preemptive analgesia approach.

All patients will receive standardized general anesthesia and routine postoperative multimodal analgesia. Intravenous tramadol will be administered postoperatively using a patient-controlled analgesia device. Postoperative pain intensity will be evaluated using the Numeric Rating Scale at predetermined time points during the first 24 hours. Total tramadol consumption, rescue analgesic requirement, postoperative nausea and vomiting, quality of recovery, mobilization time, length of hospital stay, and possible block-related complications will be recorded.

The study aims to determine whether recto-intercostal plane block provides superior postoperative analgesia compared with external oblique intercostal plane block in patients undergoing elective laparoscopic cholecystectomy.

연구 유형

관찰

등록 (추정된)

60

연락처 및 위치

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

연구 연락처

연구 장소

  • 터키 (Türkiye)
    • Istanbul
      • Sancaktepe, Istanbul, 터키 (Türkiye), 34000
        • 모병
        • Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research 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

샘플링 방법

확률 샘플

연구 인구

Adult patients aged 18-75 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled for elective laparoscopic cholecystectomy under general anesthesia and who provide written informed consent will be included.

설명

Inclusion Criteria:

  • Age between 18 and 75 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective laparoscopic cholecystectomy under general anesthesia
  • Written informed consent obtained

Exclusion Criteria:

  • Refusal to participate
  • Inability to understand the study protocol or provide informed consent
  • Known allergy to local anesthetics, tramadol, paracetamol, dexketoprofen, or other study drugs
  • Chronic opioid or steroid use
  • Psychiatric or cognitive disorder preventing reliable pain assessment
  • Inability to use patient-controlled analgesia
  • Pregnancy or breastfeeding
  • Coagulopathy
  • Infection at the block site
  • Difficult or prolonged intubation requiring three or more attempts
  • Conversion to open surgery
  • Surgery lasting longer than 120 minutes
  • Intraoperative or postoperative complications requiring deviation from the standard analgesia protocol

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
RIPB Group
Patients who received bilateral ultrasound-guided recto-intercostal plane block after anesthesia induction as part of routine preemptive analgesia for elective laparoscopic cholecystectomy.
절차: Bilateral Ultrasound-Guided Recto-Intercostal Plane Block
Bilateral recto-intercostal plane block was performed under ultrasound guidance after anesthesia induction. Local anesthetic was injected into the fascial plane between the rectus abdominis muscle and the intercostal structures as part of routine preemptive analgesia.
EOIPB Group
Patients who received bilateral ultrasound-guided external oblique intercostal plane block after anesthesia induction as part of routine preemptive analgesia for elective laparoscopic cholecystectomy.
절차: Bilateral Ultrasound-Guided External Oblique Intercostal Plane Block
Bilateral external oblique intercostal plane block was performed under ultrasound guidance after anesthesia induction. Local anesthetic was injected into the fascial plane between the external oblique muscle and the intercostal muscles as part of routine preemptive analgesia.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Cumulative Postoperative Tramadol Consumption
기간: Postoperative 24 hours
Total intravenous tramadol consumption delivered via patient-controlled analgesia during the first 24 hours after surgery.
Postoperative 24 hours

2차 결과 측정

결과 측정
측정값 설명
기간
Postoperative Pain Scores at Rest
기간: Postoperative 20 minutes, 40 minutes, 1, 3, 6, 12, 18, and 24 hours
Pain intensity at rest assessed using the Numeric Rating Scale, ranging from 0 indicating no pain to 10 indicating the worst imaginable pain.
Postoperative 20 minutes, 40 minutes, 1, 3, 6, 12, 18, and 24 hours
Postoperative Pain Scores During Activity
기간: Postoperative 20 minutes, 40 minutes, 1, 3, 6, 12, 18, and 24 hours
Pain intensity during activity assessed using the Numeric Rating Scale, ranging from 0 indicating no pain to 10 indicating the worst imaginable pain.
Postoperative 20 minutes, 40 minutes, 1, 3, 6, 12, 18, and 24 hours
Quality of Recovery
기간: Postoperative 24 hours
Quality of recovery assessed using the Quality of Recovery-15 questionnaire.Quality of recovery will be assessed using the Quality of Recovery-15 questionnaire. The Quality of Recovery-15 is a 15-item patient-reported outcome measure with a total score ranging from 0 to 150, where higher scores indicate better postoperative recovery.
Postoperative 24 hours
Rescue Analgesic Requirement
기간: Postoperative 24 hours
Number of patients requiring additional rescue analgesia due to Numeric Rating Scale score of 4 or higher.
Postoperative 24 hours
Postoperative Nausea and Vomiting
기간: Postoperative 24 hours
Incidence of postoperative nausea and vomiting during the first 24 hours after surgery.
Postoperative 24 hours
Time to Mobilization
기간: From the end of surgery until first postoperative mobilization, assessed up to 48 hours postoperatively.
Time from the end of surgery to first postoperative mobilization.
From the end of surgery until first postoperative mobilization, assessed up to 48 hours postoperatively.
Length of Hospital Stay
기간: From the date of surgery through the date of hospital discharge, assessed up to 30 days postoperatively.
Duration of postoperative hospital stay until discharge.
From the date of surgery through the date of hospital discharge, assessed up to 30 days postoperatively.
Block-Related Complications
기간: Postoperative 24 hours
Incidence of complications related to the regional block procedure, including pneumothorax and local anesthetic systemic toxicity.
Postoperative 24 hours

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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 (실제)

2026년 4월 25일

기본 완료 (추정된)

2026년 7월 22일

연구 완료 (추정된)

2026년 10월 25일

연구 등록 날짜

최초 제출

2026년 5월 15일

QC 기준을 충족하는 최초 제출

2026년 5월 20일

처음 게시됨 (실제)

2026년 5월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 20일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • RIPB-EOIPB-LC-01

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data will not be shared due to institutional data privacy policies and participant confidentiality.

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. .

수술 후 통증에 대한 임상 시험

Bilateral Ultrasound-Guided Recto-Intercostal Plane Block에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Brazil

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다