- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04112550
Clinical Effectiveness of Pre-operative Methadone in Single Level Lateral Transpsoas Interbody Fusions
Clinical Effectiveness of Pre-operative Methadone in Single Level Lateral Transpsoas Interbody Fusions: A Randomized, Double-blinded, Controlled Trial
Spinal operations including lumbar fusions for degenerative disorders are becoming more prevalent as the population ages. Inadequate or excessive postoperative analgesia can result in medical comorbidities and prolonged hospital length of stay and patient dissatisfaction.
Existing literature has highlighted the preoperative administration of methadone as a promising adjuvant for post operative pain control. Methadone has the benefit of being long-acting and has more stable serum concentration and a single preoperative dose may have significant benefits post operatively.
Here the investigators propose a prospective parallel-group, randomized, double-blinded study to assess post operative analgesic requirements after preoperative administration of either methadone 15 mg or Oxycodone 10/325. Primary outcome will be total IV and PO narcotic consumption in the post operative course. Secondary outcomes examined will include time to mobility, need for specialist pain management consultation, early readmission (within 2 weeks) for inadequate pain control, and complications associated with administration.
연구 개요
상태
상세 설명
Lumbar spinal fusions are becoming increasingly popular and prevalent in the treatment of a variety of spinal pathologies, but predominantly for degenerative disease which is most prevalent in the obese and or older population. These operations can result in relatively high post operative surgical pain and necessitate significant post operative opioid consumption which can precipitate co-morbid medical conditions such as respiratory depression and failure, pneumonia, gastrointestinal ileus, deep venous thrombosis, and pulmonary embolism. Additionally, these medical comorbidities also represent an increased burden on healthcare expenditure with increased length of hospital stay, inpatient testing and treatment, and need for additional follow up.
The investigators objective is to study the effect of a long term opioid analgesic, methadone, in a uniform population undergoing a single level minimally invasive lumbar fusion. The preoperative single dose administration of methadone has already been shown to be effective in improving post operative pain control in open multi-level spinal fusion patient populations and has become the standard of care in most surgical centers across the country. The long half-life of methadone results in improved steady state pharmacokinetics relative to other traditional opioids and is thought to improve pain control while decreasing consumption. In addition to Mu opioid receptor agonism, Methadone is thought to also have adjunctive analgesic and anti-tolerance effects due to CNS excitatory glutamatergic NMDA receptor antagonism. There are also reports of synergistic effects from serotonin and norepinephrine reuptake inhibition.
The investigators predict that a single preoperative oral methadone administration can result in improved postoperative analgesia with requirement of less IV and PO traditional narcotics within the first 2 weeks post operatively and also will not increase co-morbid risks relative to traditional shorter acting opioid analgesics that are presently given preoperatively.
연구 유형
등록 (예상)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Saeed S Sadrameli, MD, MS
- 전화번호: 2817431385
- 이메일: ssadrameli@houstonmethodist.org
연구 연락처 백업
- 이름: Marcus S Wong, MD
- 전화번호: 8324574452
- 이메일: mswong@houstonmethodist.org
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age: 18 - 70
- Will undergo one level minimally invasive lumbar fusion surgery
- Primary symptoms are back and/or leg pain
Exclusion Criteria:
- Preoperative chronic renal insufficiency or failure (defined as a serum creatinine more than 2 mg/dl)
- Significant liver disease (cirrhosis or hepatic failure)
- American Society of Anesthesiologists (ASA) physical status IV or V
- Pulmonary disease necessitating home oxygen therapy
- Patients with acute bronchial asthma or hypercarbia
- Patient who has or is suspected of having a paralytic ileus
- Preoperative use of methadone or hydromorphone
- Known hypersensitivity to methadone
- Known hypersensitivity to oxycodone
- Recent history of opioid or alcohol abuse
- Inability to use a PCA device
- Inability to speak English
- Any patient judged by the anesthesia care team to potentially require prolonged postoperative intubation
- Participation in another clinical trial
- Inability of patient to provide study informed consent (including patients who are cognitively impaired)
- Presence of drug interaction between methadone/oxycodone and patient's regular or PRN medications
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Methadone
This cohort will receive oral methadone 15mg po tablet pre-operatively
|
FDA approved medication to treat pain
|
활성 비교기: Oxycodone
This cohort will receive oxycodone/acetaminophen 10/325 po tablet pre-operatively
|
FDA approved medication to treat pain
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Post-operative in-hospital patient's narcotic requirement
기간: Post-operative day 0 to 4
|
The total Morphine Milligram Equivalent (MME) for each post-operative day
|
Post-operative day 0 to 4
|
Improvement in low back pain between the two cohorts as assessed by Oswestry Disbility Index (ODI)
기간: 14 days
|
Change in ODI (scale from 0 to 100) from pre-op to post-op (14 days post-op)
|
14 days
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Sean M Barber, MD, The Methodist Hospital Research Institute
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
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
- Pro00022567
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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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-
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