Henry Ford Hospital
Detroit, Michigan, 48202, United States
NCT Number: NCT07672808
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Detroit, Michigan, 48202, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Perioperative/Periprocedural
Total number of days from surgical admission to hospital discharge following primary total hip arthroplasty.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: up to three months postoperatively
Hip range of motion measured in degrees at postoperative follow-up visits by the treating surgeon or clinical staff.
Time frame: Up to three months postoperatively
Total distance walked in feet or meters recorded by physical therapy during inpatient physical therapy sessions following surgery.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Henry Ford Health System
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07239817
Agnosia, Anesthesia and Analgesia
Milan, Italy
View Trial DetailsNCT01536301
Agnosia, Arthroplasty, Replacement, Hip
Nîmes, Gard, France
View Trial DetailsNCT05678101
Arthroplasty, Replacement, Hip, Femoral Fractures
Stockholm, Sweden
View Trial DetailsNCT04599894
Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
Changchun, China
View Trial Details