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Comparison of Different Volumes Spread of Erector Spinae Block in Post Mastectomy Pain Syndrome Management

2021년 12월 30일 업데이트: Nevert Adel, Mansoura University

Comparison of Different Volumes Spread of Erector Spinae Block in Post Mastectomy Pain Syndrome Management: A Randomized Controlled Trial

Cancer breast is one of the most common tumors among women and surgery is still the key for its management and cure. Post-mastectomy pain control is crucial as acute postoperative pain is a significant factor in the development of persistent chronic pain in the form of post-mastectomy pain syndrome.

Post-mastectomy pain syndrome (PMPS) is a common complication after breast cancer surgery and is often challenging to manage. It is estimated that PMPS occurs in 20%-44% of patients after breast surgery.

Adequate pain control for PMPS has become one of the most important goals and recently can achieve by multiple tools including multimodal analgesia and regional techniques.

Erector spinae block (ESB) is one of the new described regional techniques. Although its mechanism is not clear, the published data agree that it is promising block for chronic and acute pain and its simplicity and safety compared with thoracic epidural or bilateral paravertebral blocks.

ESB can be performed using a superficial approach between the large rhomboid muscle and the erector spinae muscle or the deep method beneath the erector spinae.

The use of the ESPB for chronic pain has recently expanded for various neuropathic pain conditions. Also, it reported with several volumes range from 10 to 30 ml of total volume.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This prospective randomized open comparative study will be conducted in pain clinic, Mansoura University Hospitals. The study will be approved by the Ethics Research Committee of the Faculty of Medicine, Mansoura University and will be carried out in compliance with the Helsinki Declaration. Informed written consent will be signed from every patient participating in this study after full description of all details of every aspect in this study.

Patients more than 18 years old of both genders with PMPS not responding to medical treatments, and numeric rating scale (NRS) ≥ 4 that ranged from 0 (no pain) to 10 (extreme pain)., American society of Anesthesiology Physical Status class I and II, and Body mass index ˂ 30 were included in this study.

The exclusion criteria are patient refusal, local or systemic sepsis, coagulopathy, unstable cardiovascular and respiratory diseases, previous neurological deficits, history of psychiatric disorders, history of drug abuse, distorted local anatomy, and those who were allergic to the used medications were excluded from the study.

All the patients will inform about the numerical rating score (NRS) from zero to 10 (where 0 no pain, 10 the worst pain) to describe their pain.

Random selection of patients:

The study participants were randomly grouped on a scale of 1:1, using a computer-generated list of random numbers. The distribution results were sealed in an opaque envelope and kept by the study administrator. On the day of block, the study manager handed the envelope to the anesthesiologist who will perform the block.

Grouping:

Group A: receive ESR with 1mL of methylprednisolone 40mg/mL with 10 mL of 0.5% bupivacaine and 2mL of nonionic contrast in 7 ml saline 0.9% (total 20 ml with bupivacaine 0.25%).

Group B: receive ESR with 1mL of methylprednisolone 40mg/mL with 15 mL of 0.5% bupivacaine and 2mL of nonionic contrast in 12 ml saline 0.9% (total 30 ml with bupivacaine 0.25%).

연구 유형

중재적

등록 (예상)

50

단계

  • 2 단계

연락처 및 위치

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

연구 연락처

연구 연락처 백업

연구 장소

  • 이집트
      • Mansoura, 이집트
        • 모병
        • Nevert adel
        • 연락하다:
        • 연락하다:
        • 부수사관:
          • ghada F Amer, MD

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

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

Inclusion Criteria:

  • Patients more than 18 years old of both genders
  • with post-mastectomy pain syndrome not responding to medical treatments,
  • and numeric rating scale (NRS) ≥ 4 that ranged from 0 (no pain) to 10 (extreme pain).,
  • American society of Anesthesiology Physical Status class I and II,
  • and Body mass index ˂ 30 were included in this study

Exclusion Criteria:

  • patient refusal,
  • local or systemic sepsis,
  • coagulopathy,
  • unstable cardiovascular
  • and respiratory diseases,
  • previous neurological deficits,
  • history of psychiatric disorders,
  • history of drug abuse,
  • distorted local anatomy,
  • and those who were allergic to the used medications

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
활성 비교기: Group 20 ml
receive ESB with 1mL of methylprednisolone 40mg/mL with 10 mL of 0.5% bupivacaine and 2mL of nonionic contrast in 7 ml saline 0.9% (total 20 ml with bupivacaine 0.25%).
다른: erector spinae block
The patients will do the procedure under fluoroscopic guidance. The patients were placed in prone position. After the identification of the T4 transverse process, the targeted injection site was anesthetized with 3-4 ml of 2% lidocaine. A 25-gauge spinal needle was advanced until it contacted the transverse process at the T4 level. Next, a solution of 1mL of methylprednisolone 40mg/mL with 7 mL of 0.25% bupivacaine and 2mL of nonionic contrast in 10 ml saline 0.9% (group A) and in 20 ml saline 0.9% (group B) will injected. Then another photo will be taken with the fluoroscopy to determine the level of spread in each group. After finished, the patients will transfer to the post-operative care unit and will monitored for any complication for one hour.
활성 비교기: Group 30 ml
receive ESB with 1mL of methylprednisolone 40mg/mL with 15 mL of 0.5% bupivacaine and 2mL of nonionic contrast in 12 ml saline 0.9% (total 30 ml with bupivacaine 0.25%).
다른: erector spinae block
The patients will do the procedure under fluoroscopic guidance. The patients were placed in prone position. After the identification of the T4 transverse process, the targeted injection site was anesthetized with 3-4 ml of 2% lidocaine. A 25-gauge spinal needle was advanced until it contacted the transverse process at the T4 level. Next, a solution of 1mL of methylprednisolone 40mg/mL with 7 mL of 0.25% bupivacaine and 2mL of nonionic contrast in 10 ml saline 0.9% (group A) and in 20 ml saline 0.9% (group B) will injected. Then another photo will be taken with the fluoroscopy to determine the level of spread in each group. After finished, the patients will transfer to the post-operative care unit and will monitored for any complication for one hour.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The level spread of each volume.
기간: immediately after injection. C arm photo will be taken to know the level of distribution
The level spread of each volume.
immediately after injection. C arm photo will be taken to know the level of distribution
Numerical analogue scale
기간: after 4 weeks from procedure
from 0 (no pain) to 10 (sever pain)
after 4 weeks from procedure
Numerical analogue scale
기간: after 8 weeks from procedure
from 0 (no pain) to 10 (sever pain)
after 8 weeks from procedure
Numerical analogue scale
기간: after 12 weeks from procedure
from 0 (no pain) to 10 (sever pain)
after 12 weeks from procedure

2차 결과 측정

결과 측정
측정값 설명
기간
Patient satisfaction
기간: after 4 weeks from the procedure
evaluated by using a linear scale in which 0 is very dissatisfied and 10 is very satisfied.
after 4 weeks from the procedure

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Mansoura University

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)

2021년 12월 12일

기본 완료 (예상)

2022년 6월 1일

연구 완료 (예상)

2022년 9월 1일

연구 등록 날짜

최초 제출

2021년 12월 13일

QC 기준을 충족하는 최초 제출

2021년 12월 30일

처음 게시됨 (실제)

2022년 1월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 1월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 12월 30일

마지막으로 확인됨

2021년 12월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • R.21.11.1523

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. .

유방암에 대한 임상 시험

erector spinae block에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

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CROs in Suriname

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다