오피오이드 프리 정형외과
오피오이드가 없는 다양한 정형외과 절차를 검사하는 이중 맹검 무작위 통제 시험
The goal of this investigation is to compare effectiveness of this multimodal regimen at controlling postoperative pain with and without the use of opioid medications.
연구 개요
상세 설명
Prolonged opioid usage after orthopaedic surgery is an important consideration for both the opioid epidemic and postoperative outcomes. The investigators have developed a multimodal pain control regimen designed to decrease or even potentially eliminate the need for opioids after an orthopedic procedure. This is a prospective double blinded randomized controlled trial utilizing a multimodal pain regimen consisting of education and our standard multimodal pain control regimen. Then, the plan is to randomize patients to receive either encapsulated opioids or placebo. The team will assess patient's pain levels, satisfaction, opioid usage, side effects, patient reported outcomes, and complications. This study will serve as a foundation for future opioid-free surgeries and investigations, while helping to identify patients and factors at risk for prolonged opioid usage postoperatively.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
-
-
Georgia
-
Atlanta, Georgia, 미국, 30322
- Emory University Hospital
-
Atlanta, Georgia, 미국, 30029
- The Emory Clinic
-
Tucker, Georgia, 미국, 30084
- Emory Orthopedic and Spine Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Any patient with advanced arthritis undergoing a total joint replacement (e.g. total shoulder arthroplasty, anatomic or reverse), in the primary setting.
- Any patient undergoing an orthopaedic procedure or surgery of their finger, hand, wrist, forearm, or elbow
- Any patient undergoing an orthopaedic procedure or surgery for their hip, knee, ankle or foot
- Patients who have exhausted 3+ months of nonoperative treatment to include activity modifications, optional corticosteroid injections, and physical therapy.
- Patients over the age of 18 years old that are willing to participate in the study and mentally capable to consent
Exclusion Criteria:
- Patients with concurrent and significant injuries to other bones or organs, local infections, history of alcohol or medical abuse, preoperative opioid use within 3 months of the surgery, advanced renal or liver disease, contraindication to receiving a nerve block, uncontrolled diabetes mellitus (HbA1C >9.0), or if a prior gastric ulcer precludes Aspirin and anti-inflammatory medications. Prior to inclusion, the patient will undergo blood testing to evaluate both kidney and liver function, including estimated glomerular filtration rate (GFR) as well as alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
- Workman's compensation status, minors, vulnerable subjects, women who are pregnant, or those who are not willing to consent to participate in the study.
- Patients who, in the opinion of the investigator, may be non-compliant with study schedules or procedures
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: Opioid Group
Participants will receive encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed after surgery Safety" Prescription: Oxycodone5 mg po q6 hours as needed for pain |
Encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed |
|
실험적: Placebo Group
Participants will receive encapsulated placebo tablets x24, to take po q6 hours as need for pain after surgery "Safety" Prescription: Oxycodone5 mg po q6 hours as needed for pain |
Encapsulated placebo tablets x24, to take po q6 hours as need for pain |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Pain (VAS) Score
기간: Three times a day postoperatively for the first 2 weeks, then 3 months, 6 months, 12 months, and 24 months postoperative
|
The investigators will assess patient postoperative pain utilizing a visual analog scale (VAS) for the first 14 days postoperatively. They will also assess pain at each postoperative visit after at 6 weeks, 3 months, 6 months, 12 months and 24 months. This scale will assess pain at 3 different timepoints throughout the day defined as morning, afternoon, and evening. The pain scale will range from 0-10 with 10 being a worse outcome quantifying the highest pain rating. |
Three times a day postoperatively for the first 2 weeks, then 3 months, 6 months, 12 months, and 24 months postoperative
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postoperative Opioid Consumption
기간: Postoperative Days 1-14
|
Total opioid consumption in Morphine milligram equivalents (MME) during the first 2 weeks after surgery will be measured. |
Postoperative Days 1-14
|
|
Number of participants that required Rescue Opioid Prescription
기간: Postoperative Days 1-14
|
Number of participants that required the prescribed rescue ("safety") opioid prescription during the first 2 postoperative weeks. |
Postoperative Days 1-14
|
|
Number of tables consumed as Rescue Opioid
기간: Postoperative Days 1-14
|
Number of tablets taken from the prescribed rescue ("safety") opioid prescription during the first 2 postoperative weeks. |
Postoperative Days 1-14
|
|
Number of Additional Opioid Prescription Refills
기간: Postoperative Days 1-14
|
Number of additional opioid prescription refills required during the postoperative period. |
Postoperative Days 1-14
|
|
Number of participants experiencing Postoperative Nausea
기간: Three times a day postoperatively for the first 2 weeks
|
Number of participants experiencing nausea during the postoperative period. This scale will assess nausea at 3 different timepoints throughout the day defined as morning, afternoon, and evening. The scale will range from 0-10 with 10 being a worse outcome quantifying the highest nausea rating. |
Three times a day postoperatively for the first 2 weeks
|
|
Hand/Wrist function Measured by the Single Assessment Numeric Evaluation (SANE)
기간: Baseline (Preoperative); and at 3, 6, 12, and 24 months postoperatively.
|
The Single Assessment Numeric Evaluation (SANE) score requires the patient to rate their injured extremity 0-100 as a percentage of their function compared to normal. A rating of 0 is the minimum value and denotes the worse outcome a patient can have on the scale. |
Baseline (Preoperative); and at 3, 6, 12, and 24 months postoperatively.
|
|
Upper Extremity Function Measured by the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
기간: Baseline (Preoperative); and at 12 and 24 months postoperatively.
|
Upper extremity disability will be assessed using the QuickDASH questionnaire. Scores range from 0 to 100, with lower scores indicating less disability. |
Baseline (Preoperative); and at 12 and 24 months postoperatively.
|
|
Overall Satisfaction with the procedure and Pain Management
기간: 12 and 24 months postoperatively
|
Overall satisfaction with the surgical procedure and postoperative pain management will be assessed using a patient-reported 5-point rating scale. Participants will select one of the following responses: "Very satisfied", "satisfied", "neutral", "dissatisfied", and "Very dissatisfied". Responses are assigned a score from 1 to 5, where 1 corresponds to "very dissatisfied" and 5 corresponds to "very satisfied". Higher scores indicate greater satisfaction and better perceived outcomes |
12 and 24 months postoperatively
|
|
Willingness to undergo the same procedure with the same pain management
기간: 12 and 24 months postoperatively
|
Number of Participants that confirm their willingness to undergo the same procedure again using the same postoperative pain management regimen. |
12 and 24 months postoperatively
|
|
Number of participants Experiencing Major Postoperative Complications
기간: From surgery through 24 months postoperatively
|
Number of participants experiencing one or more major postoperative complications, including temporary or permanent nerve injury, hematoma, superficial or deep infection, recurrent moderate or severe pain, fracture, implant loosening, dislocation, or revision surgery. |
From surgery through 24 months postoperatively
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Eric Wagner, MD, Emory University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- STUDY00000478
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
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. .