Multimodal Analgesic Regimen for Total Hip Arthroplasty: An Initiative to Minimize Postoperative Opioid Use
2026年6月22日 更新者：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.
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
100
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Antonio M Pellerito, BA
- 電話番号：586-859-3258
- メール：ampeller@umich.edu
研究場所
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Michigan
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Detroit、Michigan、アメリカ、48202
- Henry Ford Hospital
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コンタクト：
- Antonio Pellerito, BA
- 電話番号：586-859-3258
- メール：ampeller@umich.edu
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
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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.
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実験的：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.
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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).
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Postoperative Pain Score (Visual Analog Scale)
時間枠：Preoperative baseline through 3 weeks postoperatively
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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.
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Preoperative baseline through 3 weeks postoperatively
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Postoperative Nausea Score (Visual Analog Scale)
時間枠：Preoperative baseline through 3 weeks postoperatively
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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.
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Preoperative baseline through 3 weeks postoperatively
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Opioid Consumption
時間枠：Three weeks post-op
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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.
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Three weeks post-op
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Antiemetic Consumption
時間枠：three weeks postoperatively
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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.
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three weeks postoperatively
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Length of Hospital Stay
時間枠：Perioperative/Periprocedural
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Total number of days from surgical admission to hospital discharge following primary total hip arthroplasty.
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Perioperative/Periprocedural
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Episodes of Nausea
時間枠：Three weeks postoperatively
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Number of nausea episodes documented.
Inpatient episodes collected via electronic medical record; post-discharge episodes recorded by the patient in a postoperative pain journal.
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Three weeks postoperatively
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Hip Injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR.)
時間枠：Up to three months postoperatively
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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.
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Up to three months postoperatively
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Harris Hip Score
時間枠：Up to three months postoperatively
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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.
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Up to three months postoperatively
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PROMIS Physical Function
時間枠：Up to three months postoperatively
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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.
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Up to three months postoperatively
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Timed Up and Go Test (TUG)
時間枠：Prior to hospital discharge, assessed up to 2 weeks postoperatively
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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
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Prior to hospital discharge, assessed up to 2 weeks postoperatively
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Range of Motion (ROM)
時間枠：up to three months postoperatively
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Hip range of motion measured in degrees at postoperative follow-up visits by the treating surgeon or clinical staff.
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up to three months postoperatively
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Distance Walked During Physical Therapy Sessions
時間枠：Up to three months postoperatively
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Total distance walked in feet or meters recorded by physical therapy during inpatient physical therapy sessions following surgery.
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Up to three months postoperatively
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Surgical Site Infection
時間枠：Up to three months postoperatively
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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.
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Up to three months postoperatively
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Acute Prosthetic Joint Infection
時間枠：Up to three months postoperatively
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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.
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Up to three months postoperatively
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Wound Dehiscence
時間枠：Up to three months postoperatively
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Occurrence of wound dehiscence at the surgical site following primary total hip arthroplasty, identified during clinical follow-up visits or by chart review.
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Up to three months postoperatively
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PROMIS Pain Interference
時間枠：Up to three months postoperatively
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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.
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Up to three months postoperatively
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PROMIS Emotional Distress: Depression
時間枠：Up to three months postoperatively
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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.
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Up to three months postoperatively
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Michael Charters, MD、Henry Ford Health System
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2026年12月1日
研究の完了 (推定)
2027年5月30日
試験登録日
最初に提出
2026年6月5日
QC基準を満たした最初の提出物
2026年6月22日
最初の投稿 (実際)
2026年6月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月29日
QC基準を満たした最後の更新が送信されました
2026年6月22日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 14751-27
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