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Erector Spinae Plane Block for Rib Fracture Analgesia in the Emergency Department

2021년 5월 15일 업데이트: Dana Sajed, University of Southern California

Rib fractures, while in isolation are self-limited and benign, can be exquisitely painful. Poorly controlled rib fracture pain can compromise respiratory function leading to increased morbidity and mortality, especially in the elderly. Currently, opioid medications are the mainstay of analgesia but are associated with significant adverse effects, such as respiratory depression and delirium. In an effort to improve acute pain in the ED and concomitantly reduce opioid use, ultrasound-guided regional anesthesia has been implemented more frequently The erector spinae plane block (ESPB) is a relatively new ultrasound-guided procedure for thoracic analgesia.

Previously, the serratus anterior plane (SAP) block has been used for this indication. However, typical anatomical distribution limits the effectiveness of the SAP block to anterior rib fractures, while the majority of traumatic rib fractures are posterior, thus require a more central blockade such as the proposed ESPB. The ESPB can be done as a single injection into the superficial structures of the back under ultrasound guidance and as such, is a both a relatively safe and technically easy procedure to perform, especially in comparison to the more traditional alternatives of epidurals, paravertebral and intercostal injections.

There have been no prospective studies evaluating the efficacy and safety of the ESPB in the emergency department setting for acute rib fractures. The investigators hypothesize that the ESPB will provide improved acute pain scores in the emergency department compared to parental analgesia alone. Secondarily, investigators hypothesize that this will translate to less inpatient opioid requirements and improved incentive spirometry values.

연구 개요

상태

아직 모집하지 않음

상세 설명

Rib fractures, while in isolation are self-limited and benign, can be exquisitely painful. Poorly controlled rib fracture pain can compromise respiratory function leading to increased morbidity and mortality, especially in the elderly. Currently, opioid medications are the mainstay of analgesia but are associated with significant adverse effects, such as respiratory depression and delirium. Additionally, even short courses can predispose to life-long addiction perpetuating the opioid epidemic. In an effort to improve acute pain in the ED and concomitantly reduce opioid use, ultrasound-guided regional anesthesia has been implemented more frequently. As an example, ultrasound-guided peripheral nerve blocks for hip fractures have a promising track record for reducing opioid use and improving pain scores. The erector spinae plane block (ESPB) is a relatively new ultrasound-guided procedure for thoracic analgesia. It was first described in 2016 by Forero, et al., as an effective alternative to traditional neuraxial blockade for post-operative and chronic thoracic pain. A recent literature review by Kot et al., 2019 revealed six prospective studies in post-operative patients concluding that the ESPB was at least as effective as opioids in thoracic pain reduction, easy to use and with a low complication rate. One prospective study in post-operative breast surgery patients demonstrated a reduction in morphine by 65% compared to control. Most literature on the ESPB in the ED are case reports, which demonstrate its versatility in a myriad of clinical situations such as renal colic, acute herpes zoster, acute transverse process fractures, extensive burns, mechanical back pain, acute pancreatitis and acute rib fractures. This review found the ESPB to be effective at reducing pain scores for all reported indications with no complications. The ESPB is a particularly attractive multimodal form of analgesia in the ED where acute traumatic rib fractures are a common presentation. Usually the involuntary splinting from acute pain results in the typical pulmonary complications, but high doses of opioids and the subsequent respiratory depressive effects can lead to higher rates of atelectasis, pneumonia and respiratory failure. In order to combat this "between a rock and a hard place" scenario, regional analgesia has emerged as an effective means of improving both pain respiratory mechanics. Previously, the serratus anterior plane (SAP) block has been used for this indication. However, typical anatomical distribution limits the effectiveness of the SAP block to anterior rib fractures, while the majority of traumatic rib fractures are posterior, thus require a more central blockade such as the proposed ESPB. The ESPB can be done as a single injection into the superficial structures of the back under ultrasound guidance and as such, is a both a relatively safe and technically easy procedure to perform, especially in comparison to the more traditional alternatives of epidurals, paravertebral and intercostal injections. Another consideration of these technically more difficult procedures is that they are relatively contraindicated in the anticoagulated patient precluding a substantial number of elderly patients from their therapeutic benefits. The aforementioned reviews have supported the safety of the ESPB with no complications reported. Specifically, of the 10 case reports utilizing this block in the ED, none reported any complications. The 3 cases reported by Luftig et al, in 2018 specific to ED management of acute rib fractures were technically feasible, highly efficacious and safe. However, there have been no prospective studies evaluating the efficacy and safety of the ESPB in the emergency department setting for acute rib fractures. The investigators hypothesize that the ESPB will provide improved acute pain scores in the emergency department compared to parental analgesia alone. Secondarily, the investigators hypothesize that this will translate to less inpatient opioid requirements and improved incentive spirometry values.

연구 유형

중재적

등록 (예상)

40

단계

  • 해당 없음

연락처 및 위치

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

연구 연락처

  • 이름: Dana Sajed
  • 전화번호: 858 361 4685
  • 이메일: sajed@usc.edu

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 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Age >=18
  • At least 1 acute rib fracture. Acute defined as within 7 days of presentation.
  • Numerical pain score on presentation at least 5 out of 10. This will identify patients that justify the invasive procedure.
  • Admitted to hospital for at least 24 hours of observation.
  • Be able to consent and participate in study by assuming necessary positioning for intervention

Exclusion Criteria:

  • Hypotension/shock (shock index >1.0, SBP < 90)
  • Distracting injury not amenable to ESPB as determined by the enrolling physician. (i.e extremity fracture, burn, laceration, contusion, joint dislocation, etc.)
  • Examples of patients not able to consent/participate are intubated patients or patients in spinal precautions (i.e c-collar)
  • Known hypersensitivity to local anesthetic
  • Evidence of infection at the proposed site of injection

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: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: ESPB Block
Patients with rib fracture randomized to block group
Nerve block with local anesthetic in the erector spinae plane
다른 이름들:
  • 신경 차단
  • 건설자 Spinae 블록
활성 비교기: Standard Care
Patients with rib fracture receiving IV analgesia/standard care
IV analgesia, typically Morphine/Opioid medications
다른 이름들:
  • 모르핀
  • 오피오이드

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
To determine the effectiveness of the ESPB for pain management of acute rib fractures in the emergency department using a 10 point isual analog scale
기간: 0, 1, 2 and 24 hours assessment
Change in pain level from fractures as measured using a visual analog scale
0, 1, 2 and 24 hours assessment

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Tom Mailhot, MD, LAC+USC Medical Center

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 (예상)

2021년 7월 1일

기본 완료 (예상)

2022년 6월 30일

연구 완료 (예상)

2022년 8월 31일

연구 등록 날짜

최초 제출

2021년 5월 12일

QC 기준을 충족하는 최초 제출

2021년 5월 15일

처음 게시됨 (실제)

2021년 5월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 5월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 5월 15일

마지막으로 확인됨

2021년 5월 1일

추가 정보

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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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