Pain ManagementCORENCT04176783
Opioid-Free Orthopaedic Surgery
A study testing Opioids and Opioid-Free in people with Pain Management, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial summary
To compare the safety and effectiveness of two pain control pathways following routine orthopaedic surgical procedures (single level or two-level ACDF/ACDA, 1st CMC arthroplasty, Hallux Valgus/Rigidus corrections, diagnostic knee arthroscopies, total hip arthroplasty, and total shoulder arthroplasty / reverse total… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management
- What is being tested?
- Opioids and Opioid-Free
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 511 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2018to 31 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patient is scheduled to undergo one of the following procedures:
- Primary single-level or two-level ACDF or ACDA for degenerative disease
- Primary 1st CMC arthroplasty
- Primary Hallux Valgus or Hallux Rigidus correction
- Diagnostic knee arthroscopy +/- meniscal debridement
- Elective primary total shoulder or reverse total shoulder arthroplasty
- Primary total hip arthroplasty
Who cannot join
- Revision surgery for one of the study-specific procedures
- Chronic opioid therapy - per investigator discretion
- Significant liver disease - (NOTE: Patients with a history of liver disease will have a hepatic panel drawn to be reviewed by the study investigator to asses if the values are within acceptable limits for inclusion in the study)
- Fracture or soft tissue injury
- Sickle cell disease
- Workers compensation
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- Alcohol dependence
- Contra-indication to regional anesthesia
- History of gastrointestinal (GI) bleeding or peptic ulcer
- History of bleeding problems
- Patients taking anticoagulants, not including aspirin (only applies to Randomized portion of study. These patients can still participate in Observational Control Group)
- Renal insufficiency - Creatinine clearance less than 30 mL/min (only applies to patients having surgery requiring NSAIDs treatment)
- Outpatient THA or TSA/RTSA
- Hammertoe in isolation (Hallux Valgus/Rigidus exclusion only)
- Concomitant meniscal repair or microfracture (Knee Arthroscopy exclusion only)
- Ineligible for spinal anesthesia (THA exclusion only)
- Previous ipsilateral hip surgery, not including hip scope (THA exclusion only)
- Allergy to non-steroidal anti-inflammatory medications (NSAIDs)
Trial locations and contacts
1 site in 1 country.
United States1 site
OrthoCarolina, P.A.
Charlotte, North Carolina, 28207
About this study
Official title: Carolina's Opioid Reduction Effort
To compare the safety and effectiveness of two pain control pathways following routine orthopaedic surgical procedures (single level or two-level ACDF/ACDA, 1st CMC arthroplasty, Hallux Valgus/Rigidus corrections, diagnostic knee arthroscopies, total hip arthroplasty, and total shoulder arthroplasty / reverse total shoulder arthroplasty). The control group will undergo surgery with an opioid-based pain protocol and the intervention group will undergo surgery with a multimodal, opioid-free protocol.
Patients will have data collected with respect to pain scores, overall comfort level, overall satisfaction with the surgical experience and recovery, constipation, falls, and overall satisfaction with pain control, in addition to procedure-specific outcome scores and patient-specific metrics.
- Conditions
- Pain Management
- Being tested
- Opioids, Opioid-Free
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpioidsDrug
Also called Control
narcotic pain medicine
Opioid-FreeDrug
Also called Intervention, Non-Opioid
non narcotoc pain medication
| Study group | Role | What they receive |
|---|---|---|
| Opioid | Active comparator | The opioid-based arm utilizes traditional, standard-of-care treatment for each applicable surgery. The medications (including dosage and frequency) used in this arm vary depending on the surgery being performed; however, tend to include medications in the opioid family such as Hydromorphone, Hydrocodone, Tramadol, or Oxycodone. Receives: Drug: Opioids |
| Opioid-Free | Active comparator | The opioid-free arm utilizes medications that do not belong to the opioid family of medications. All medications used are FDA-approved and no experimental medications are being used. The medications (including dosage and frequency) used in this arm vary depending on the surgery being performed; however, tend to include medications such as Gabapentin, Tylenol, Meloxicam, Bupivacaine, or Ketorolac. Receives: Drug: Opioid-Free |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at 24 hours postop
Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score
Measured: 24 hours
Secondary outcomes (6)
Pain at 6 hours postop
Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score
Measured: 6 hours
Pain at 12 hours postop
Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score
Measured: 12 hours
Pain at 2 weeks postop
Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score
Measured: 2 weeks
Pain at 6 weeks postop
Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score
Measured: 6 weeks
Pain at 1 year postop
Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score
Measured: 1 year
General Health
Veterans Rand-12
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start26 Mar 2018
- Primary completion21 Jul 2021
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nady M Hamid, MD, Principal investigator, OrthoCarolina Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176783
- Sponsor's protocol ID
- 9120
- Acronym
- CORE
- Status last verified
- Mar 2025
- First submitted
- 16 Apr 2018
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Publications
Shing EZ, Leas D, Michalek C, Wally MK, Hamid N. Study protocol: randomized controlled trial of opioid-free vs. traditional perioperative analgesia in elective orthopedic surgery. BMC Musculoskelet Disord. 2021 Jan 23;22(1):104. doi: 10.1186/s12891-021-03972-9.
PubMed 33485328
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carolina's Opioid Reduction Effort
- ClinicalTrials.gov ID
- NCT04176783
- Acronym / sponsor ID
- CORE / 9120
- Conditions
- Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 Nov 2019 (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.
To compare the safety and effectiveness of two pain control pathways following routine orthopaedic surgical procedures (single level or two-level ACDF/ACDA, 1st CMC arthroplasty, Hallux Valgus/Rigidus corrections, diagnostic knee arthroscopies, total hip arthroplasty, and total shoulder arthroplasty / reverse total shoulder arthroplasty). The control group will undergo surgery with an opioid-based pain protocol and the intervention group will undergo surgery with a multimodal, opioid-free protocol.
Patients will have data collected with respect to pain scores, overall comfort level, overall satisfaction with the surgical experience and recovery, constipation, falls, and overall satisfaction with pain control, in addition to procedure-specific outcome scores and patient-specific metrics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Opioid | Active comparator | Drug: OpioidsThe opioid-based arm utilizes traditional, standard-of-care treatment for each applicable surgery. The medications (including dosage and frequency) used in this arm vary depending on the surgery being performed; however, tend to include medications in the opioid family such as Hydromorphone, Hydrocodone, Tramadol, or Oxycodone. |
| Opioid-Free | Active comparator | Drug: Opioid-FreeThe opioid-free arm utilizes medications that do not belong to the opioid family of medications. All medications used are FDA-approved and no experimental medications are being used. The medications (including dosage and frequency) used in this arm vary depending on the surgery being performed; however, tend to include medications such as Gabapentin, Tylenol, Meloxicam, Bupivacaine, or Ketorolac. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Primary single-level or two-level ACDF or ACDA for degenerative disease
- Primary 1st CMC arthroplasty
- Primary Hallux Valgus or Hallux Rigidus correction
- Diagnostic knee arthroscopy +/- meniscal debridement
- Elective primary total shoulder or reverse total shoulder arthroplasty
Key exclusion criteria (18 listed)
- Revision surgery for one of the study-specific procedures
- Chronic opioid therapy - per investigator discretion
- Significant liver disease - (NOTE: Patients with a history of liver disease will have a hepatic panel drawn to be reviewed by the study investigator to asses if the values are within acceptable limits for inclusion in the study)
- Fracture or soft tissue injury
- Sickle cell disease
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 |
|---|---|---|
| OpioidsAlso: Controlnarcotic pain medicine | Drug | Opioid |
| Opioid-FreeAlso: Intervention, Non-Opioidnon narcotoc pain medication | Drug | Opioid-Free |
Primary outcome
Pain at 24 hours postop
Time frame: 24 hours
Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score
6 secondary outcomes
Pain at 6 hours postop
Time frame: 6 hours
Pain at 12 hours postop
Time frame: 12 hours
Pain at 2 weeks postop
Time frame: 2 weeks
Pain at 6 weeks postop
Time frame: 6 weeks
Pain at 1 year postop
Time frame: 1 year
General Health
Time frame: 1 year
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 20 Mar 2025.
- Derived from this study: PubMed 33485328Shing EZ, Leas D, Michalek C, Wally MK, Hamid N. Study protocol: randomized controlled trial of opioid-free vs. traditional perioperative analgesia in elective orthopedic surgery. BMC Musculoskelet Disord. 2021 Jan 23;22(1):104. doi: 10.1186/s12891-021-03972-9.
- Individual participant dataSharing planned: No. No plan
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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.
Nady M Hamid, MD principal investigator
OrthoCarolina Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioids and Opioid-Free in people with Pain Management, run by OrthoCarolina Research Institute, Inc. 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 18 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 20 Mar 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?
Pain at 24 hours postop (time frame: 24 hours). 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 NCT04176783, which also lists 1 linked publication.
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 20 Mar 2025; AzTrials last refreshed its copy on 28 Oct 2026.