Pain, PostoperativeCARENCT04885231
Impact of Counseling and Education on Opioid Consumption After ACL Reconstruction
A study testing Perioperative Pain Management Education and Counseling in people with Pain, Postoperative and Opioid Use, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Research question: Does an opioid limiting pain management counseling and education program result in decreased opioid consumption and improved pain control compared to traditional pain management programs after anterior cruciate ligament reconstruction (ACLR) surgery? At many institutions, the current standard of… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Pain, Postoperative, Opioid Use
- What is being tested?
- Perioperative Pain Management Education and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2021to 29 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Men and women aged 14 years and older
- All patients scheduled to undergo an ACLR with or without concomitant procedures such as arthroscopic cartilage procedures, meniscus repair or meniscectomy, and/or lateral extraarticular tenodesis (anterolateral ligament reconstruction)
- Willing to participate in a perioperative pain management education and counseling program
- Willing to track pain levels and opioid consumption through surveys administered via text
- Willing to receive a perioperative regional nerve block
- Language skills and cognitive ability required to participate in the study
- Provision of informed consent
Who cannot join
- Revision ACLR
- Concomitant open cartilage procedures or additional knee ligament repair or reconstruction
- Concomitant injury that would also influence pain management
- History of heroin use or opioid abuse requiring treatment
- If any previous ipsilateral knee surgery except for knee arthroscopy
- Preoperative Kellgren-Lawrence grade 3 and 4 on weightbearing radiographs
Show all 10Show fewer
- An allergy to any of the study medications
- Previously enrolled in the CARE trial
- Anticipated problems with the patient returning for follow-up or accurate completion of survey
- If patient cannot reliably receive texts and use internet to complete surveys
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Rehabilitation and Orthopaedic Institute
Baltimore, Maryland, 21207
About this study
Official title: Impact of Counseling and Education on Opioid Consumption After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
Research question: Does an opioid limiting pain management counseling and education program result in decreased opioid consumption and improved pain control compared to traditional pain management programs after anterior cruciate ligament reconstruction (ACLR) surgery?
At many institutions, the current standard of care is to instruct patients to take opioid pain medicine as needed when in severe pain to "stay ahead of the pain." This study is investigating whether modifying the instructions to take opioid pain medications only if in "unbearable pain" will have an effect on 1) reducing opioid consumption and 2) improving pain levels.
Read more
Adults who are undergoing an ACLR surgery will be invited to participate in the study and be randomly assigned to one of the two pain management programs. All patients will receive a comprehensive multi-modality pain management treatments and medications. Patients in both groups will receive the same type and amount of all postoperative medications. The only difference will be in the instructions about when to take the opioid medications.
The patients will then be sent an electronic survey twice per day for 2 weeks about their pain levels and number of opioid pills taken.
Read the detailed description
Prescription narcotic pain medications (opioids) were responsible for roughly 17,000 deaths in 2016 in the United States. Orthopedic surgeons were responsible for prescribing the third highest percentage of opioids among physicians in 2009. In recent years, orthopaedic surgeons have used many different types of non-opioid pain medications and methods to reduce patients' opioid after surgery. Opioid dependence can manifest from prescription use, especially in patients who have never used opioids before.
The purpose of this study is to research the effect of different pain management education programs on pain control and opioid use after an anterior cruciate ligament reconstruction (ACLR) surgery. Specifically, does education directed at avoiding opioids unless in "unbearable pain" have any effect on reducing pain levels and opioid consumption in the early postoperative period compared to traditional pain management education?
Patients who agree to participate in this study will be assigned at random to two opioid education programs after ACLR. All patients will be given peri-operative pain management counseling and education. Patients in the experimental group will be instructed to avoid opioids unless in unbearable pain. Patients in the control group will be instructed to take opioid medication as needed for severe pain to "stay ahead" of the pain. Participants in both groups will be prescribed the exact same type and amount of postoperative medications.
Surveys will be sent electronically to patients twice per day for 2 weeks to monitor pain levels and the amount of opioid consumption. Also, patients will be asked to complete demographic and patient-reported outcome questionnaires after surgery. Patients will be involved in the study for 3 months.
- Conditions
- Pain, Postoperative, Opioid Use
- Being tested
- Perioperative Pain Management Education and Counseling
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative Pain Management Education and CounselingBehavioural
All patients will receive both verbal postoperative pain management education and counseling as well as a written handout. Multi-modality non-opioid methods of pain control will be thoroughly discussed.
| Study group | Role | What they receive |
|---|---|---|
| Opioid-Limiting Perioperative Pain Management Education and Counseling | Experimental | Patients will be instructed to take oxycodone only as a last resort if the pain becomes unbearable. "The goal should be to take as little oxycodone as possible." Receives: Behavioral: Perioperative Pain Management Education and Counseling |
| Traditional Perioperative Pain Management Education and Counseling | Active comparator | Patients will be instructed to take opioids as needed for severe pain to manage and "stay ahead" of the postoperative pain Receives: Behavioral: Perioperative Pain Management Education and Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
The total morphine equivalents (TMEs) consumed by the patient after surgery
Measured: 3 months
Secondary outcomes (9)
Numeric Pain Scale
Participants will record a Numeric Pain Scale (NPS) score every day on a scale of 0-10, where 0= no pain and 10= worst possible pain. Mean NPS values for each postoperative day will be compared between groups.
Measured: Two weeks
Patient Reported Outcomes - Satisfaction with social roles & activities
Patient reported social satisfaction will be assessed after surgery using PROMIS Satisfaction with Social roles and Activities questionnaire
Measured: 2 weeks, 6 weeks, 3 months
Patient Reported Outcomes - Physical Function
Patient reported physical functioning will be assessed after surgery using PROMIS Physical Function questionnaire
Measured: 2 weeks, 6 weeks, 3 months
Patient Reported Outcomes - Pain
Patient reported pain will be assessed after surgery using PROMIS Pain Interference questionnaire
Measured: 2 weeks, 6 weeks, 3 months
Patient Reported Outcomes - Fatigue
Patient reported fatigue will be assessed after surgery using PROMIS Fatigue questionnaire
Measured: 2 weeks, 6 weeks, 3 months
Patient Reported Outcomes - Depression
Patient reported depression will be assessed after surgery using PROMIS Emotional Distress - Depression questionnaire
Measured: 2 weeks, 6 weeks, 3 months
Patient Reported Outcomes - Anxiety
Patient reported anxiety will be assessed after surgery using PROMIS Emotional Distress - Anxiety questionnaire
Measured: 2 weeks, 6 weeks, 3 months
Opioid Prescription Refills
The mean number of opioid prescription refills per patient will be compared between the two treatment groups.
Measured: 3 months
Patient Satisfaction
Patient satisfaction will be assessed by the Surgical Satisfaction Survey (SSQ-8), with responses ranging from Very Satisfied to Very Unsatisfied.
Measured: 2 weeks, 6 weeks, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start12 May 2021
- Primary completion1 Sep 2024
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center randomized control trial consisting of two groups - one control and one experimental.
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan D. Packer, MD, University of Maryland, Baltimore
- Investigators
- Jonathan D. Packer, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885231
- Sponsor's protocol ID
- HP-00093883
- Acronym
- CARE
- Status last verified
- Apr 2025
- First submitted
- 2 May 2021
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andelman SM, Bu D, Debellis N, Nwachukwu C, Osman N, Gladstone JN, Colvin AC. Preoperative Patient Education May Decrease Postoperative Opioid Use After Meniscectomy. Arthrosc Sports Med Rehabil. 2019 Dec 20;2(1):e33-e38. doi: 10.1016/j.asmr.2019.10.006. eCollection 2020 Feb.
PubMed 32266356Aso K, Izumi M, Sugimura N, Okanoue Y, Kamimoto Y, Yokoyama M, Ikeuchi M. Additional benefit of local infiltration of analgesia to femoral nerve block in total knee arthroplasty: double-blind randomized control study. Knee Surg Sports Traumatol Arthrosc. 2019 Jul;27(7):2368-2374. doi: 10.1007/s00167-018-5322-7. Epub 2018 Dec 8.
PubMed 30536047Dysart SH, Barrington JW, Del Gaizo DJ, Sodhi N, Mont MA. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Early Outcomes After Total Knee Arthroplasty: 24-Hour Data From the PILLAR Study. J Arthroplasty. 2019 May;34(5):882-886.e1. doi: 10.1016/j.arth.2018.12.026. Epub 2018 Dec 25.
PubMed 30799269Hyland SJ, Deliberato DG, Fada RA, Romanelli MJ, Collins CL, Wasielewski RC. Liposomal Bupivacaine Versus Standard Periarticular Injection in Total Knee Arthroplasty With Regional Anesthesia: A Prospective Randomized Controlled Trial. J Arthroplasty. 2019 Mar;34(3):488-494. doi: 10.1016/j.arth.2018.11.026. Epub 2018 Nov 23.
PubMed 30554925Kim N, Matzon JL, Abboudi J, Jones C, Kirkpatrick W, Leinberry CF, Liss FE, Lutsky KF, Wang ML, Maltenfort M, Ilyas AM. A Prospective Evaluation of Opioid Utilization After Upper-Extremity Surgical Procedures: Identifying Consumption Patterns and Determining Prescribing Guidelines. J Bone Joint Surg Am. 2016 Oct 19;98(20):e89. doi: 10.2106/JBJS.15.00614.
PubMed 27869630Kuang MJ, Du Y, Ma JX, He W, Fu L, Ma XL. The Efficacy of Liposomal Bupivacaine Using Periarticular Injection in Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. J Arthroplasty. 2017 Apr;32(4):1395-1402. doi: 10.1016/j.arth.2016.12.025. Epub 2016 Dec 23.
PubMed 28082044Kumar K, Gulotta LV, Dines JS, Allen AA, Cheng J, Fields KG, YaDeau JT, Wu CL. Unused Opioid Pills After Outpatient Shoulder Surgeries Given Current Perioperative Prescribing Habits. Am J Sports Med. 2017 Mar;45(3):636-641. doi: 10.1177/0363546517693665. Epub 2017 Feb 9.
PubMed 28182507Kunze KN, Polce EM, Lilly DT, Garcia FL, Cohn MR, Nho SJ, Chahla J. Adjunct Analgesia Reduces Pain and Opioid Consumption After Hip Arthroscopy: A Systematic Review of Randomized Controlled Trials. Am J Sports Med. 2020 Dec;48(14):3638-3651. doi: 10.1177/0363546520905884. Epub 2020 Mar 2.
PubMed 32119562McLaughlin DC, Cheah JW, Aleshi P, Zhang AL, Ma CB, Feeley BT. Multimodal analgesia decreases opioid consumption after shoulder arthroplasty: a prospective cohort study. J Shoulder Elbow Surg. 2018 Apr;27(4):686-691. doi: 10.1016/j.jse.2017.11.015. Epub 2018 Jan 3.
PubMed 29305103Namdari S, Nicholson T, Abboud J, Lazarus M, Steinberg D, Williams G. Interscalene Block with and without Intraoperative Local Infiltration with Liposomal Bupivacaine in Shoulder Arthroplasty: A Randomized Controlled Trial. J Bone Joint Surg Am. 2018 Aug 15;100(16):1373-1378. doi: 10.2106/JBJS.17.01416.
PubMed 30106818Pitchon DN, Dayan AC, Schwenk ES, Baratta JL, Viscusi ER. Updates on Multimodal Analgesia for Orthopedic Surgery. Anesthesiol Clin. 2018 Sep;36(3):361-373. doi: 10.1016/j.anclin.2018.05.001. Epub 2018 Jul 11.
PubMed 30092934Rucinski K, Cook JL. Effects of preoperative opioid education on postoperative opioid use and pain management in orthopaedics: A systematic review. J Orthop. 2020 Jan 21;20:154-159. doi: 10.1016/j.jor.2020.01.020. eCollection 2020 Jul-Aug.
PubMed 32025140Schoenfeld AJ, Jiang W, Chaudhary MA, Scully RE, Koehlmoos T, Haider AH. Sustained Prescription Opioid Use Among Previously Opioid-Naive Patients Insured Through TRICARE (2006-2014). JAMA Surg. 2017 Dec 1;152(12):1175-1176. doi: 10.1001/jamasurg.2017.2628.
PubMed 28813584Sethi PM, Brameier DT, Mandava NK, Miller SR. Liposomal bupivacaine reduces opiate consumption after rotator cuff repair in a randomized controlled trial. J Shoulder Elbow Surg. 2019 May;28(5):819-827. doi: 10.1016/j.jse.2019.01.008. Epub 2019 Mar 28.
PubMed 30928396Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period. JAMA Intern Med. 2016 Sep 1;176(9):1286-93. doi: 10.1001/jamainternmed.2016.3298.
PubMed 27400458
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Counseling and Education on Opioid Consumption After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04885231
- Acronym / sponsor ID
- CARE / HP-00093883
- Conditions
- Pain, Postoperative, Opioid Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research question: Does an opioid limiting pain management counseling and education program result in decreased opioid consumption and improved pain control compared to traditional pain management programs after anterior cruciate ligament reconstruction (ACLR) surgery?
At many institutions, the current standard of care is to instruct patients to take opioid pain medicine as needed when in severe pain to "stay ahead of the pain." This study is investigating whether modifying the instructions to take opioid pain medications only if in "unbearable pain" will have an effect on 1) reducing opioid consumption and 2) improving pain levels.
Adults who are undergoing an ACLR surgery will be invited to participate in the study and be randomly assigned to one of the two pain management programs. All patients will receive a comprehensive multi-modality pain management treatments and medications. Patients in both groups will receive the same type and amount of all postoperative medications. The only difference will be in the instructions about when to take the opioid medications.
The patients will then be sent an electronic survey twice per day for 2 weeks about their pain levels and number of opioid pills taken.
Detailed description
Prescription narcotic pain medications (opioids) were responsible for roughly 17,000 deaths in 2016 in the United States. Orthopedic surgeons were responsible for prescribing the third highest percentage of opioids among physicians in 2009. In recent years, orthopaedic surgeons have used many different types of non-opioid pain medications and methods to reduce patients' opioid after surgery. Opioid dependence can manifest from prescription use, especially in patients who have never used opioids before.
The purpose of this study is to research the effect of different pain management education programs on pain control and opioid use after an anterior cruciate ligament reconstruction (ACLR) surgery. Specifically, does education directed at avoiding opioids unless in "unbearable pain" have any effect on reducing pain levels and opioid consumption in the early postoperative period compared to traditional pain management education?
Patients who agree to participate in this study will be assigned at random to two opioid education programs after ACLR. All patients will be given peri-operative pain management counseling and education. Patients in the experimental group will be instructed to avoid opioids unless in unbearable pain. Patients in the control group will be instructed to take opioid medication as needed for severe pain to "stay ahead" of the pain. Participants in both groups will be prescribed the exact same type and amount of postoperative medications.
Surveys will be sent electronically to patients twice per day for 2 weeks to monitor pain levels and the amount of opioid consumption. Also, patients will be asked to complete demographic and patient-reported outcome questionnaires after surgery. Patients will be involved in the study for 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center randomized control trial consisting of two groups - one control and one experimental.
| Arm | Type | Receives |
|---|---|---|
| Opioid-Limiting Perioperative Pain Management Education and Counseling | Experimental | Behavioral: Perioperative Pain Management Education and CounselingPatients will be instructed to take oxycodone only as a last resort if the pain becomes unbearable. "The goal should be to take as little oxycodone as possible." |
| Traditional Perioperative Pain Management Education and Counseling | Active comparator | Behavioral: Perioperative Pain Management Education and CounselingPatients will be instructed to take opioids as needed for severe pain to manage and "stay ahead" of the postoperative pain |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women aged 14 years and older
- All patients scheduled to undergo an ACLR with or without concomitant procedures such as arthroscopic cartilage procedures, meniscus repair or meniscectomy, and/or lateral extraarticular tenodesis (anterolateral ligament reconstruction)
- Willing to participate in a perioperative pain management education and counseling program
- Willing to track pain levels and opioid consumption through surveys administered via text
- Willing to receive a perioperative regional nerve block
Key exclusion criteria (10 listed)
- Revision ACLR
- Concomitant open cartilage procedures or additional knee ligament repair or reconstruction
- Concomitant injury that would also influence pain management
- History of heroin use or opioid abuse requiring treatment
- If any previous ipsilateral knee surgery except for knee arthroscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perioperative Pain Management Education and CounselingAll patients will receive both verbal postoperative pain management education and counseling as well as a written handout. Multi-modality non-opioid methods of pain control will be thoroughly discussed. | Behavioural | Opioid-Limiting Perioperative Pain Management Education and Counseling, Traditional Perioperative Pain Management Education and Counseling |
Primary outcome
Postoperative opioid consumption
Time frame: 3 months
The total morphine equivalents (TMEs) consumed by the patient after surgery
9 secondary outcomes
Numeric Pain Scale
Time frame: Two weeks
Patient Reported Outcomes - Satisfaction with social roles & activities
Time frame: 2 weeks, 6 weeks, 3 months
Patient Reported Outcomes - Physical Function
Time frame: 2 weeks, 6 weeks, 3 months
Patient Reported Outcomes - Pain
Time frame: 2 weeks, 6 weeks, 3 months
Patient Reported Outcomes - Fatigue
Time frame: 2 weeks, 6 weeks, 3 months
Patient Reported Outcomes - Depression
Time frame: 2 weeks, 6 weeks, 3 months
Patient Reported Outcomes - Anxiety
Time frame: 2 weeks, 6 weeks, 3 months
Opioid Prescription Refills
Time frame: 3 months
Patient Satisfaction
Time frame: 2 weeks, 6 weeks, and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Background: PubMed 32266356Andelman SM, Bu D, Debellis N, Nwachukwu C, Osman N, Gladstone JN, Colvin AC. Preoperative Patient Education May Decrease Postoperative Opioid Use After Meniscectomy. Arthrosc Sports Med Rehabil. 2019 Dec 20;2(1):e33-e38. doi: 10.1016/j.asmr.2019.10.006. eCollection 2020 Feb.
- Background: PubMed 30536047Aso K, Izumi M, Sugimura N, Okanoue Y, Kamimoto Y, Yokoyama M, Ikeuchi M. Additional benefit of local infiltration of analgesia to femoral nerve block in total knee arthroplasty: double-blind randomized control study. Knee Surg Sports Traumatol Arthrosc. 2019 Jul;27(7):2368-2374. doi: 10.1007/s00167-018-5322-7. Epub 2018 Dec 8.
- Background: PubMed 30799269Dysart SH, Barrington JW, Del Gaizo DJ, Sodhi N, Mont MA. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Early Outcomes After Total Knee Arthroplasty: 24-Hour Data From the PILLAR Study. J Arthroplasty. 2019 May;34(5):882-886.e1. doi: 10.1016/j.arth.2018.12.026. Epub 2018 Dec 25.
- Background: PubMed 30554925Hyland SJ, Deliberato DG, Fada RA, Romanelli MJ, Collins CL, Wasielewski RC. Liposomal Bupivacaine Versus Standard Periarticular Injection in Total Knee Arthroplasty With Regional Anesthesia: A Prospective Randomized Controlled Trial. J Arthroplasty. 2019 Mar;34(3):488-494. doi: 10.1016/j.arth.2018.11.026. Epub 2018 Nov 23.
- Background: PubMed 27869630Kim N, Matzon JL, Abboudi J, Jones C, Kirkpatrick W, Leinberry CF, Liss FE, Lutsky KF, Wang ML, Maltenfort M, Ilyas AM. A Prospective Evaluation of Opioid Utilization After Upper-Extremity Surgical Procedures: Identifying Consumption Patterns and Determining Prescribing Guidelines. J Bone Joint Surg Am. 2016 Oct 19;98(20):e89. doi: 10.2106/JBJS.15.00614.
- Background: PubMed 28082044Kuang MJ, Du Y, Ma JX, He W, Fu L, Ma XL. The Efficacy of Liposomal Bupivacaine Using Periarticular Injection in Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. J Arthroplasty. 2017 Apr;32(4):1395-1402. doi: 10.1016/j.arth.2016.12.025. Epub 2016 Dec 23.
- Background: PubMed 28182507Kumar K, Gulotta LV, Dines JS, Allen AA, Cheng J, Fields KG, YaDeau JT, Wu CL. Unused Opioid Pills After Outpatient Shoulder Surgeries Given Current Perioperative Prescribing Habits. Am J Sports Med. 2017 Mar;45(3):636-641. doi: 10.1177/0363546517693665. Epub 2017 Feb 9.
- Background: PubMed 32119562Kunze KN, Polce EM, Lilly DT, Garcia FL, Cohn MR, Nho SJ, Chahla J. Adjunct Analgesia Reduces Pain and Opioid Consumption After Hip Arthroscopy: A Systematic Review of Randomized Controlled Trials. Am J Sports Med. 2020 Dec;48(14):3638-3651. doi: 10.1177/0363546520905884. Epub 2020 Mar 2.
- Background: PubMed 29305103McLaughlin DC, Cheah JW, Aleshi P, Zhang AL, Ma CB, Feeley BT. Multimodal analgesia decreases opioid consumption after shoulder arthroplasty: a prospective cohort study. J Shoulder Elbow Surg. 2018 Apr;27(4):686-691. doi: 10.1016/j.jse.2017.11.015. Epub 2018 Jan 3.
- Background: PubMed 30106818Namdari S, Nicholson T, Abboud J, Lazarus M, Steinberg D, Williams G. Interscalene Block with and without Intraoperative Local Infiltration with Liposomal Bupivacaine in Shoulder Arthroplasty: A Randomized Controlled Trial. J Bone Joint Surg Am. 2018 Aug 15;100(16):1373-1378. doi: 10.2106/JBJS.17.01416.
- Background: PubMed 30092934Pitchon DN, Dayan AC, Schwenk ES, Baratta JL, Viscusi ER. Updates on Multimodal Analgesia for Orthopedic Surgery. Anesthesiol Clin. 2018 Sep;36(3):361-373. doi: 10.1016/j.anclin.2018.05.001. Epub 2018 Jul 11.
- Background: PubMed 32025140Rucinski K, Cook JL. Effects of preoperative opioid education on postoperative opioid use and pain management in orthopaedics: A systematic review. J Orthop. 2020 Jan 21;20:154-159. doi: 10.1016/j.jor.2020.01.020. eCollection 2020 Jul-Aug.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan D. Packer, MD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perioperative Pain Management Education and Counseling in people with Pain, Postoperative and Opioid Use, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid consumption (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04885231, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.