Patients With Acute Hip Fractures Will Receive Either the PENG Block or no Block Respectively. (PENGBlock)
Evaluation of the PENG Block vs Placebo for Preoperative Pain Control in Hip Fractures in the Elderly - a Double-blinded Randomised Controlled Trial
Hip fracture pain is often severe and traditionally managed by systemic opioids which have increased risk of side effects in frail elderly patients. Inadequately controlled pain may lead to delirium which increases mortality and morbidity. The overall aim of this RCT is to investigate the potential for improved pain relief accomplished by the addition of the PENG block to current standard practice of pre-operative analgesia (systemic morphine), compared to the control group, which involves no block (operator will still go through the motion as if performing a block) plus standard pre-operative analgesia.
The investigator hypothesize that the addition of a single shot PENG block at the side of hip fracture in addition to traditional systemic morphine provides good preoperative pain relief on movement and reduces the need for breakthrough opioid requirements. The investigator hypothesize that the interventional group dynamic pain score assessed at 30 minutes after the block compared to control group dynamic pain score at 30 minutes after the "block" will be at least a 3 point difference between the 2 groups .
연구 개요
상세 설명
Specific Aim1: To determine difference in pain scores on movement (dynamic pain scores) in patients who receive the PENG block in the intervention group compared to no block in the control group at 30 minutes after performance of the block.
Specific Aim2: To determine if there is any difference in pain at rest between the intervention group and the control group, and if so, the magnitude of the difference in pain scores.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Singapore, 싱가포르, 169608
- 모병
- Pain Management Center Sinagpore General Hospital
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연락하다:
- Diana Xin Hui Chan
- 전화번호: 63266162
- 이메일: diana.chan.x.h@singhealth.com.sg
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 60 years old and above
- Provided consent for the study
- Patients with solitary hip fracture (no other fracture) - intracapsular neck of femur fracture, intertrochanteric fracture
- Either awaiting hip fracture surgery or no plans for hip fracture surgery within the next 24 hours
Exclusion Criteria:
- Patients with cognitive impairment or inability to give consent, or refusal to give consent
- Multiple fracture cases
- Peri-prosthetic fractures and revisions
- Subclinical vertebral fractures
- Hip fractures due to major accidents such as road traffic accidents, fall from height or more than 2 meters
- Multiple trauma
- Pathological fractures secondary to metastases
Patients with contraindications to block performance
- Coagulopathy as demonstrated by PT/PTT/INR
- On antiplatelets or anticoagulation
- Infection/ compromised skin integrity at site of block performance
- Allergy to local anaesthetics and opioids
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: Control
Only standard care
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스탠다드 케어
다른 이름들:
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실험적: Intervention group
The PENG block was performed for intervention group with local anaesthetic solution composed of 20 ml of ropivacaine 0.5%.
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Local anaesthetic solution composed of ropivacaine 0.5%(intervention group)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Dynamic pain scores (Numerical pain score (NRS) at 15 degrees leg lift)
기간: 30 minutes after receiving intervention
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The difference in dynamic pain scores (NRS at 15 degrees leg lift) at 30 minutes post block performance in the intervention group vs the control group.
Assessment of the dynamic pain score is done prior to discharge from recovery at SGH Pain Management Centre.
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30 minutes after receiving intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain scores (NRS) at rest (static pain) and on movement (dynamic pain)
기간: Up to 24 hours from performance of block
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It is measured at Baseline, Immediately after performance of block, 30 minutes after the lock in recovery At 60 minutes, 180 minutes and 24 hours post block in the ward
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Up to 24 hours from performance of block
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Pain scores collected to estimate the onset and duration of block Pain scores to estimate the onset and duration of block
기간: Up to 24 hours from performance of block
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Taking the recorded time taken for the pain relieve to estimate onset time using models
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Up to 24 hours from performance of block
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Total opioid use over 24 hours as a surrogate measure
기간: Up to 24 hours from performance of block
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Using the data recorded for : Oral morphine use Intravenous morphine use for patients on PCA Doses of opioid use will be converted to morphine milligram equivalent daily dose (MEDD) for standardized comparison. |
Up to 24 hours from performance of block
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Tay E. Hip fractures in the elderly: operative versus nonoperative management. Singapore Med J. 2016 Apr;57(4):178-81. doi: 10.11622/smedj.2016071.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2 (기타 식별자: Instituto Cardiovascular de Buenos Aires)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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