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CARE: Impact of Counseling and Education on Opioid Consumption After ACL Reconstruction

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Recruiting
CT.gov ID
NCT04885231
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
19.6
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Perioperative Pain Management Education and Counseling
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single center randomized control trial consisting of two groups - one control and one experimental.Single center randomized control trial consisting of two groups - one control and one experimental.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Impact of Counseling and Education on Opioid Consumption After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
Actual Study Start Date :
May 12, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Opioid-Limiting Perioperative Pain Management Education and Counseling

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."

Behavioral: Perioperative Pain Management Education and Counseling
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.
Active Comparator: Traditional Perioperative Pain Management Education and Counseling

Patients will be instructed to take opioids as needed for severe pain to manage and "stay ahead" of the postoperative pain

Behavioral: Perioperative Pain Management Education and Counseling
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.

Outcome Measures

Primary Outcome Measures

  1. Postoperative opioid consumption [3 months]

    The total morphine equivalents (TMEs) consumed by the patient after surgery

Secondary Outcome Measures

  1. Numeric Pain Scale [Two weeks]

    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.

  2. Patient Reported Outcomes - Satisfaction with social roles & activities [2 weeks, 6 weeks, 3 months]

    Patient reported social satisfaction will be assessed after surgery using PROMIS Satisfaction with Social roles and Activities questionnaire

  3. Patient Reported Outcomes - Physical Function [2 weeks, 6 weeks, 3 months]

    Patient reported physical functioning will be assessed after surgery using PROMIS Physical Function questionnaire

  4. Patient Reported Outcomes - Pain [2 weeks, 6 weeks, 3 months]

    Patient reported pain will be assessed after surgery using PROMIS Pain Interference questionnaire

  5. Patient Reported Outcomes - Fatigue [2 weeks, 6 weeks, 3 months]

    Patient reported fatigue will be assessed after surgery using PROMIS Fatigue questionnaire

  6. Patient Reported Outcomes - Depression [2 weeks, 6 weeks, 3 months]

    Patient reported depression will be assessed after surgery using PROMIS Emotional Distress - Depression questionnaire

  7. Patient Reported Outcomes - Anxiety [2 weeks, 6 weeks, 3 months]

    Patient reported anxiety will be assessed after surgery using PROMIS Emotional Distress - Anxiety questionnaire

  8. Opioid Prescription Refills [3 months]

    The mean number of opioid prescription refills per patient will be compared between the two treatment groups.

  9. Patient Satisfaction [2 weeks, 6 weeks, and 3 months]

    Patient satisfaction will be assessed by the Surgical Satisfaction Survey (SSQ-8), with responses ranging from Very Satisfied to Very Unsatisfied.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Men and women aged 14 years and older

  2. 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)

  3. Willing to participate in a perioperative pain management education and counseling program

  4. Willing to track pain levels and opioid consumption through surveys administered via text

  5. Willing to receive a perioperative regional nerve block

  6. Language skills and cognitive ability required to participate in the study

  7. Provision of informed consent

Exclusion Criteria:

  1. Revision ACLR

  2. Concomitant open cartilage procedures or additional knee ligament repair or reconstruction

  3. Concomitant injury that would also influence pain management

  4. History of heroin use or opioid abuse requiring treatment

  5. If any previous ipsilateral knee surgery except for knee arthroscopy

  6. Preoperative Kellgren-Lawrence grade 3 and 4 on weightbearing radiographs

  7. An allergy to any of the study medications

  8. Previously enrolled in the CARE trial

  9. Anticipated problems with the patient returning for follow-up or accurate completion of survey

  10. If patient cannot reliably receive texts and use internet to complete surveys

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Maryland Rehabilitation and Orthopaedic Institute Baltimore Maryland United States 21207

Sponsors and Collaborators

  • University of Maryland, Baltimore

Investigators

  • Principal Investigator: Jonathan D. Packer, MD, University of Maryland, Baltimore

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jonathan D. Packer, MD, Associate Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier:
NCT04885231
Other Study ID Numbers:
  • HP-00093883
First Posted:
May 13, 2021
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pain, Postoperative

Study Results

No Results Posted as of Jul 21, 2022