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OpenTrials
Completed

NCT Number: NCT04176783

Opioid-Free Orthopaedic Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OrthoCarolina, P.A.

Charlotte, North Carolina, 28207, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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)

Treatment and study plan

Opioids

Drug

narcotic pain medicine

Other names: Control

Opioid-Free

Drug

non narcotoc pain medication

Other names: Intervention, Non-Opioid

Primary outcomes

  1. Pain at 24 hours postop

    Time frame: 24 hours

    Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score

Secondary outcomes

  1. Pain at 6 hours postop

    Time frame: 6 hours

    Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score

  2. Pain at 12 hours postop

    Time frame: 12 hours

    Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score

  3. Pain at 2 weeks postop

    Time frame: 2 weeks

    Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score

  4. Pain at 6 weeks postop

    Time frame: 6 weeks

    Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score

  5. Pain at 1 year postop

    Time frame: 1 year

    Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score

  6. General Health

    Time frame: 1 year

    Veterans Rand-12

Sponsors and collaborators

Lead sponsor

OrthoCarolina Research Institute, Inc.

Other

Registry information

Official study title

Carolina's Opioid Reduction Effort

Acronym: CORE

Important dates

Study start
2018
Primary completion
2021
Study completion
2024
First posted
Nov 25, 2019
Registry last updated
Mar 20, 2025

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.

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