일차 슬관절 전치환술에서 통증 감소를 위한 Venlafaxine의 사용
일차 슬관절 전치환술에서 급성 수술 후 통증과 오피오이드 소비를 줄이기 위한 Venlafaxine의 사용
Patients experience pain after their knee replacement surgery - and some may continue to experience persistent pain long after their knee replacement surgery. Traditional pain management strategies reply on pain medication such as opioids for pain control. However, these drugs do not work well for pain associated with movement or the the nerve pain (tingling, electrical sensations) after surgery. In addition, opioids are associated with significant side effects such as nausea, vomiting, respiratory depression, depression, cognitive dysfunction and risk of persistent opioid use. Neuropathic pain medications, such as venlafaxine are effective in managing nerve pain. Recent studies also support its potential role in acute pain management. Here, we propose a prospective randomized clinical trial 1) to evaluate the efficacy of Venlafaxine in reducing pain intensity and opioid consumption at post-operative day 1 (POD1) and 1- week after surgery, and 2) to examine whether the use of Venlafaxine will reduce the incidents of chronic postsurgical pain in TKA patients at 3-month time point.
연구 개요
상세 설명
Patients meeting the inclusion criteria will be randomized to receive either Venlafaxine extended release (ER) 37.5 mg/d or a placebo on the day of surgery and continue the treatment for 7 days after surgery. The primary outcomes include pain severity score (numeric rating scale, NRS) and consumption of morphine miligram equivalent (MME) at 24 hours. The secondary outcome will measure MME and NRS at postoperative day 7. In addition, the disability scale and perceived function 3 months after surgery will be compared to the baseline level by using PROMIS (Patient-Reported Outcomes Measurement Information System)10 Global Health, KOOS, JR. (Knee injury and Osteoarthritis Outcome Score Short Form), and VR-12 (Veterans RAND 12 Item Health Survey) Scale.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
-
-
California
-
San Francisco, California, 미국, 94143
- University of California San Francisco
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- adult (male and female) subjects aged 18 to 75,
- English speaking,
- are scheduled for primary total knee arthroplasty with planned spinal anesthesia with saphenous peripheral nerve block at the adductor canal.
Exclusion Criteria:
- general anesthesia,
- hepatic & renal failure,
- history of diabetic peripheral neuropathic pain,
- chronic opioid use,
- concurrent use of antidepressants, triptans, and/or linezolid,
- allergy to the study medications,
- prior knee surgery,
- BMI > 40,
- bleeding disorders,
- history of recent falls,
- concurrent benzodiazepine use.
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 |
|---|---|
|
위약 비교기: Placebo
Subjects in placebo arm will receive inactive placebo capsule daily for 7 consecutive days starting on day of primary arthroplasty surgery. |
placebo filled pill daily for 7 consecutive days.
다른 이름들:
|
|
실험적: Venlafaxine
Subjects in venlafaxine arm will receive venlafaxine 37.5mg daily for 7 consecutive days starting on day of primary arthroplasty surgery. |
venlafaxine 37.5mg daily for 7 consecutive days.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Total Opioid Consumption on Postoperative Day 1
기간: Postoperative Day 1
|
Total opioid consumption measured in morphine milligram equivalents (MME) on postoperative day 1. |
Postoperative Day 1
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
NRS Pain Score at Postoperative Day 1
기간: Postoperative Day 1
|
Pain Scores will be measured on the Numerical Rating Scale (NRS), the score ranges from 0-10, zero indicating no pain and 10 indicating the worst pain. |
Postoperative Day 1
|
|
BPI Pain Interference Score at Postoperative Day 7
기간: Postoperative Day 7
|
The Brief Pain Inventory (BPI) assesses the severity of pain and its impact on functioning.The BPI scale defines pain as follows:1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain. |
Postoperative Day 7
|
|
Pain Severity and Interference at 3 Months Post Operatively
기간: 3 months
|
The Brief Pain Inventory (BPI) assesses the severity of pain and its impact on functioning.The BPI scale defines pain as follows:1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain. |
3 months
|
|
Opioid Consumption at 7 Days Postoperatively
기간: 7 days
|
morphine miligram equivalent |
7 days
|
|
Functionality at 3 Months - KOOS Short Form
기간: 3 months
|
Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS-12), a 12-item patient-reported questionnaire assessing knee-related quality of life. Scored 0-100 where 0 = extreme knee problems and 100 = no knee problems. Higher scores represent better knee function. Values reported as change from baseline to 3 months postoperatively (3-month score minus baseline score); higher change scores indicate greater improvement. Assessed at baseline and 3 months postoperatively. |
3 months
|
|
Number of Participants Consuming Opioids at 3 Months
기간: 3 months
|
number of participants who reported consuming opioids at the 3-month follow-up. |
3 months
|
|
Patient Satisfaction With Pain Control
기간: Postoperative Days 1, 2, 7, and 3 months
|
Patient satisfaction with pain control measured on a 0-100 visual analog scale, where 0 = completely dissatisfied and 100 = completely satisfied. Assessed at POD1, POD2, POD7, and 3 months postoperatively. Values represent model-predicted means from mixed-effects repeated measures analysis. |
Postoperative Days 1, 2, 7, and 3 months
|
|
Functionality at 3 Months - PROMIS Global-10
기간: 3 months
|
PROMIS Global-10 (Patient-Reported Outcomes Measurement Information System), reported as T-scores standardized to the US general population (mean=50, SD=10). Four subscores reported separately: Global Mental Health (GMH), Global Physical Health (GPH), Mental Component Score (MCS), and Physical Component Score (PCS). For all subscores, higher T-scores represent better health outcomes. Values reported as change from baseline to 3 months postoperatively (3-month score minus baseline score); higher change scores indicate greater improvement. Assessed at baseline and 3 months postoperatively. |
3 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Matthias Behrends, MD, University of California, San Francisco
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
- 20-32595
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
We will share our raw clinical data with other researchers.
IPD 공유 기간
For the entire study period
IPD 공유 액세스 기준
Non-profit and research purpose.
IPD 공유 지원 정보 유형
- 연구_프로토콜
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. .