Multimodal Analgesic Regimen for Total Hip Arthroplasty: An Initiative to Minimize Postoperative Opioid Use
2026년 6월 22일 업데이트: Michael Charters, MD, Henry Ford Health System
This study examines whether patients undergoing total hip replacement surgery can manage their pain effectively while using fewer opioid pain medications.
Participants will be randomly assigned to one of two groups.
The first group will receive the standard postoperative pain medication regimen, with all prescriptions sent directly to their pharmacy as usual.
The second group will receive the same medications, but their opioid prescription will only be provided as a printed copy rather than being sent directly to the pharmacy, requiring them to choose whether to fill it.
All participants will keep a pain journal and complete questionnaires about their medication intake over the first 21 days post-op as well as there function and wellbeing at follow up visits over 3 months.
The goal is to determine whether this approach reduces opioid use while still adequately controlling pain after hip replacement surgery.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
100
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Antonio M Pellerito, BA
- 전화번호: 586-859-3258
- 이메일: ampeller@umich.edu
연구 장소
-
-
Michigan
-
Detroit, Michigan, 미국, 48202
- Henry Ford Hospital
-
연락하다:
- Antonio Pellerito, BA
- 전화번호: 586-859-3258
- 이메일: ampeller@umich.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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Adult patients age 18 and older
- Patients who have undergone total hip arthroplasty by a single, fellowship trained Orthopaedic Surgeon.
Exclusion Criteria:
- Patients with incomplete data in medical records
- Chronic opioid use in the last 3 months
- Ipsilateral joint surgery in the last year
- Cannot tolerate oral medications
- Swallowing difficulties
- Intolerance to Tylenol, Celebrex, Robaxin, Neurontin, or Tramadol
- History of Alcohol abuse
- History of Drug abuse
- History of Renal impairment
- History of Peptic ulcer disease
- History of GI bleeding
- Illicit narcotic usage in past 6 months
- Chronic liver disease
- Chronic pain syndrome
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 |
|---|---|
|
활성 비교기: Standard Postoperative Pain Protocol (Control)
Participants receive the standard postoperative multimodal pain regimen following primary total hip arthroplasty.
All prescriptions, including opioids, are sent directly to the patient's pharmacy per usual care.
Participants complete a postoperative pain journal, medication log, respond to phone/text check-ins regarding pain scores, and complete PROMIS, HOOS Jr., and Harris Hip Score questionnaires at follow-up visits postoperatively.
|
Participants receive the standard postoperative multimodal pain regimen following primary total hip arthroplasty.
All prescriptions are sent directly to the patient's pharmacy.
Opioid consumption tracked via the Michigan Automated Prescription System (MAPS) and patient medication journal.
Pain and medication consumption are assessed via daily pain/medication logs daily for the first week, then weekly for two additional weeks.
|
|
실험적: Opioid-Reduced Postoperative Pain Protocol (Treatment)
Participants receive the standard postoperative multimodal pain regimen following primary total hip arthroplasty.
Opioid prescriptions (Tramadol) are printed and given to the patient rather than sent directly to the pharmacy, requiring the patient to drive to the pharmacy if they choose to fill them.
Participants complete a postoperative pain journal, mediation logs, respond to phone/text check-ins, and complete PROMIS, HOOS Jr., and Harris Hip Score questionnaires at follow-up visits postoperatively.
|
Participants receive the standard postoperative multimodal pain regimen following primary total hip arthroplasty.
Tramadol is prescribed but the prescription is printed and given to the patient rather than sent to the pharmacy, requiring the patient to actively choose to fill it.
This behavioral barrier is designed to reduce opioid consumption while preserving patient autonomy.
Pain and medication intake is assessed via daily pain journals and medication logs for the first week, then weekly for two additional weeks.
Opioid consumption is also tracked via the Michigan Automated Prescription System (MAPS).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postoperative Pain Score (Visual Analog Scale)
기간: Preoperative baseline through 3 weeks postoperatively
|
Pain severity measured using a visual analog scale (VAS) scored 0-10, where 0 represents no pain and 10 represents the worst possible pain.
Scores collected preoperatively, daily during inpatient admission, daily for the first week post-discharge, then weekly for 2 additional weeks via patient pain journal and phone/text check-ins.
|
Preoperative baseline through 3 weeks postoperatively
|
|
Postoperative Nausea Score (Visual Analog Scale)
기간: Preoperative baseline through 3 weeks postoperatively
|
Nausea severity measured using a visual analog scale (VAS) scored 0-10, where 0 represents no nausea and 10 represents the worst possible nausea.
Scores collected preoperatively, daily during inpatient admission, daily for the first week post-discharge, then weekly for 2 additional weeks via patient pain journal and phone/text check-ins.
|
Preoperative baseline through 3 weeks postoperatively
|
|
Opioid Consumption
기간: Three weeks post-op
|
Total opioid consumption measured in morphine milligram equivalents (MME) and by dose and quantity.
Inpatient opioid use collected via electronic medical record and the Michigan Automated Prescription System (MAPS).
Post-discharge opioid use recorded by the patient in a postoperative pain journal.
|
Three weeks post-op
|
|
Antiemetic Consumption
기간: three weeks postoperatively
|
Total antiemetic consumption recorded by dose and quantity.
Inpatient use collected via electronic medical record; post-discharge use recorded by the patient in a postoperative pain journal.
|
three weeks postoperatively
|
|
Length of Hospital Stay
기간: Perioperative/Periprocedural
|
Total number of days from surgical admission to hospital discharge following primary total hip arthroplasty.
|
Perioperative/Periprocedural
|
|
Episodes of Nausea
기간: Three weeks postoperatively
|
Number of nausea episodes documented.
Inpatient episodes collected via electronic medical record; post-discharge episodes recorded by the patient in a postoperative pain journal.
|
Three weeks postoperatively
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Hip Injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR.)
기간: Up to three months postoperatively
|
Patient-reported outcome measure assessing hip pain and function specific to joint replacement patients.
Scored on a 0-100 scale, with higher scores indicating better hip function.
Administered at scheduled postoperative follow-up visits.
|
Up to three months postoperatively
|
|
Harris Hip Score
기간: Up to three months postoperatively
|
Clinician-administered outcome measure assessing hip pain, function, absence of deformity, and range of motion following total hip arthroplasty.
Scored on a scale of 0 to 100, where higher scores indicate better hip function and outcomes.
|
Up to three months postoperatively
|
|
PROMIS Physical Function
기간: Up to three months postoperatively
|
Patient-reported outcome measure assessing self-reported capability to perform physical activities.
Administered via the PROMIS Physical Function item bank at scheduled postoperative follow-up visits.
Scores are reported as T-scores with a mean of 50 and standard deviation of 10 in the general population, where higher scores indicate better physical function.
|
Up to three months postoperatively
|
|
Timed Up and Go Test (TUG)
기간: Prior to hospital discharge, assessed up to 2 weeks postoperatively
|
Functional mobility test measuring the time in seconds for a patient to rise from a chair, walk 3 meters, turn, walk back, and sit down.
Administered by physical therapy prior to hospital discharge
|
Prior to hospital discharge, assessed up to 2 weeks postoperatively
|
|
Range of Motion (ROM)
기간: up to three months postoperatively
|
Hip range of motion measured in degrees at postoperative follow-up visits by the treating surgeon or clinical staff.
|
up to three months postoperatively
|
|
Distance Walked During Physical Therapy Sessions
기간: Up to three months postoperatively
|
Total distance walked in feet or meters recorded by physical therapy during inpatient physical therapy sessions following surgery.
|
Up to three months postoperatively
|
|
Surgical Site Infection
기간: Up to three months postoperatively
|
Occurrence of superficial or deep surgical site infection at the operative site following primary total hip arthroplasty, identified during clinical follow-up visits or by chart review.
|
Up to three months postoperatively
|
|
Acute Prosthetic Joint Infection
기간: Up to three months postoperatively
|
Occurrence of acute periprosthetic joint infection following primary total hip arthroplasty, identified during clinical follow-up visits or by chart review per standard clinical criteria.
|
Up to three months postoperatively
|
|
Wound Dehiscence
기간: Up to three months postoperatively
|
Occurrence of wound dehiscence at the surgical site following primary total hip arthroplasty, identified during clinical follow-up visits or by chart review.
|
Up to three months postoperatively
|
|
PROMIS Pain Interference
기간: Up to three months postoperatively
|
Patient-reported outcome measure assessing the degree to which pain interferes with daily activities and social participation.
Administered via the PROMIS Pain Interference item bank at scheduled postoperative follow-up visits.
Scores are reported as T-scores with a mean of 50 and standard deviation of 10 in the general population, where higher scores indicate greater pain interference.
|
Up to three months postoperatively
|
|
PROMIS Emotional Distress: Depression
기간: Up to three months postoperatively
|
Patient-reported outcome measure assessing depressive symptoms including helplessness, hopelessness, and emotional exhaustion.
Administered via the PROMIS Emotional Distress.
Depression item bank at scheduled postoperative follow-up visits.
Scores are reported as T-scores with a mean of 50 and standard deviation of 10 in the general population, where higher scores indicate greater emotional distress.
|
Up to three months postoperatively
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Michael Charters, MD, Henry Ford Health System
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Beakley BD, Kaye AM, Kaye AD. Tramadol, Pharmacology, Side Effects, and Serotonin Syndrome: A Review. Pain Physician. 2015 Jul-Aug;18(4):395-400.
- Scully RE, Schoenfeld AJ, Jiang W, Lipsitz S, Chaudhary MA, Learn PA, Koehlmoos T, Haider AH, Nguyen LL. Defining Optimal Length of Opioid Pain Medication Prescription After Common Surgical Procedures. JAMA Surg. 2018 Jan 1;153(1):37-43. doi: 10.1001/jamasurg.2017.3132.
- Cho CH, Song KS, Min BW, Lee KJ, Ha E, Lee YC, Lee YK. Multimodal approach to postoperative pain control in patients undergoing rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2011 Oct;19(10):1744-8. doi: 10.1007/s00167-010-1294-y. Epub 2010 Oct 19.
- Fiore JF Jr, Olleik G, El-Kefraoui C, Verdolin B, Kouyoumdjian A, Alldrit A, Figueiredo AG, Valanci S, Marquez-GdeV JA, Schulz M, Moldoveanu D, Nguyen-Powanda P, Best G, Banks A, Landry T, Pecorelli N, Baldini G, Feldman LS. Preventing opioid prescription after major surgery: a scoping review of opioid-free analgesia. Br J Anaesth. 2019 Nov;123(5):627-636. doi: 10.1016/j.bja.2019.08.014. Epub 2019 Sep 25.
- Fiore JF Jr, El-Kefraoui C, Chay MA, Nguyen-Powanda P, Do U, Olleik G, Rajabiyazdi F, Kouyoumdjian A, Derksen A, Landry T, Amar-Zifkin A, Bergeron A, Ramanakumar AV, Martel M, Lee L, Baldini G, Feldman LS. Opioid versus opioid-free analgesia after surgical discharge: a systematic review and meta-analysis of randomised trials. Lancet. 2022 Jun 18;399(10343):2280-2293. doi: 10.1016/S0140-6736(22)00582-7.
- Chia PA, Cannesson M, Bui CCM. Opioid free anesthesia: feasible? Curr Opin Anaesthesiol. 2020 Aug;33(4):512-517. doi: 10.1097/ACO.0000000000000878.
- Moutzouros V, Jildeh TR, Khalil LS, Schwartz K, Hasan L, Matar RN, Okoroha KR. A Multimodal Protocol to Diminish Pain Following Common Orthopedic Sports Procedures: Can We Eliminate Postoperative Opioids? Arthroscopy. 2020 Aug;36(8):2249-2257. doi: 10.1016/j.arthro.2020.04.018. Epub 2020 Apr 28.
- Pirkle S, Reddy S, Bhattacharjee S, Shi LL, Lee MJ. Chronic Opioid Use Is Associated With Surgical Site Infection After Lumbar Fusion. Spine (Phila Pa 1976). 2020 Jun 15;45(12):837-842. doi: 10.1097/BRS.0000000000003405.
- Bravo L, Mico JA, Berrocoso E. Discovery and development of tramadol for the treatment of pain. Expert Opin Drug Discov. 2017 Dec;12(12):1281-1291. doi: 10.1080/17460441.2017.1377697. Epub 2017 Sep 17.
- Goldman AH, Griffis CE, Johnson DD, Balazs GC. Shifts in Prescribers' Initial Postoperative Opioid Prescriptions Following Primary Total Hip Arthroplasty Between 2014 and 2018. J Arthroplasty. 2020 Nov;35(11):3208-3213. doi: 10.1016/j.arth.2020.06.002. Epub 2020 Jun 10.
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 (추정된)
2026년 6월 1일
기본 완료 (추정된)
2026년 12월 1일
연구 완료 (추정된)
2027년 5월 30일
연구 등록 날짜
최초 제출
2026년 6월 5일
QC 기준을 충족하는 최초 제출
2026년 6월 22일
처음 게시됨 (실제)
2026년 6월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 22일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 14751-27
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .