Opioid-Free Orthopaedic Surgery

Not Applicable

Active, not recruiting

• Conditions: Pain Management
• Interventions: Drug: Opioids; Drug: Opioid-Free

• Registration Number: NCT04176783
• Lead Sponsor: OrthoCarolina Research Institute, Inc.

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-26
• Study First Submitted: 2018-04-16
• Study First Submitted QC: 2019-11-22
• Study First Posted: 2019-11-25
• Primary Completion: 2021-07-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 511

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid	Opioids	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.
Opioid-Free	Opioid-Free	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.

Primary Outcome Measures

Name	Time	Method
Pain at 24 hours postop	24 hours	Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score

Secondary Outcome Measures

Name	Time	Method
Pain at 1 year postop	1 year	Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score
General Health	1 year	Veterans Rand-12
Pain at 12 hours postop	12 hours	Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score
Pain at 2 weeks postop	2 weeks	Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score
Pain at 6 weeks postop	6 weeks	Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score
Pain at 6 hours postop	6 hours	Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score

Trial Locations

Locations (1)

OrthoCarolina, P.A.; 🇺🇸 Charlotte, North Carolina, United States