Multimodal Analgesia in Shoulder Arthroplasty

NCT03586934 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: ORA 17071004
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Opioid medications are associated with many side effects and the risk of abuse or overdose. Orthopaedic surgeons are currently investigating ways to control pain after surgery while limiting the amount of opioid medications prescribed. One way to reduce the amount of opioid medications prescribed, and potentially avoid opioid-associated adverse events, is to use multiple non-opioid medications and anesthetic drugs before surgery, during surgery, and after surgery. This study aims to evaluate a protocol with non-opioid pain medications to reduce the need for opioid medication after shoulder surgery.

Conditions

Shoulder Pain; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Number of Oxycodone tablets

  Number of tablets taken by patient after hospital discharge

  From time of discharge until the date the subject is no longer using oxycodone or up 90 days after surgery, whichever came first

Secondary Outcomes (6)

• Patient Reported Outcome Measures

  administered preoperatively, 6 weeks, 3 months

• Shoulder range of motion and strength testing

  tested as appropriate at 3 weeks, 6 weeks, and 3 months

• Complications

  Up to 90 days

• Pain Score

  From time of randomization until the date of hospital discharge, assessed up to 90 days after surgery.

• Postoperative Inpatient Opioid Utilization

  From time of randomization until the date of hospital discharge, assessed up to 90 days after surgery.

Other Outcomes (1)

• Illinois Prescription Monitoring Program (IPMP)

  Up to 90 days

Study Arms (2)

Traditional (Standard) Protocol

OTHER

Preoperative Single shot interscalene block (30 mL 0.5 ropivacaine), postoperative morphine patient controlled analgesia (1 mg/10 min/30 mg) with Hydrocodone-Acetaminophen (oral, 5/325 mg, 1 tab q4h pro re nata (PRN) for pain score of 1-3), Hydrocodone-Acetaminophen (oral, 10/325 mg, 1 tab q4h PRN for pain score of 4-6) Morphine injectable solution (2 mg IV q3h PRN for pain score 7-10), and oxycodone hydrochloride (oral, 10 mg q12h x2 doses) through postoperative day one. Discharged from hospital with hydrocodone bitartrate and acetaminophen (Norco) (5/325 mg or 10/325 mg, 1-2 oral tabs q4-6h PRN pain) script.

Drug: Ropivacaine; Drug: Morphine Injectable Solution; Drug: hydrocodone bitartrate and acetaminophen; Drug: Morphine; Drug: Oxycodone Hydrochloride

Multimodal Anesthesia and Analgesia

EXPERIMENTAL

Under age 75: Preop: acetaminophen 1000 mg oral, celecoxib 400 mg oral. Interscalene block (30 ml 0.5% ropivacaine with 1:200,000 epinephrine). Intraop: ketorolac 15 mg IV, acetaminophen injectable product. Postop: acetaminophen 500 mg oral, oxycontin 10 mg oral. Breakthrough: ketorolac 15 mg IV, oxycodone 10 mg oral. Floor: tramadol 100 mg q6h oral, acetaminophen 1 g q8h oral, celecoxib 200 mg q12h oral, ketorolac 15 mg IV q6h. Breakthrough: Pain scores 4-6: oxycodone 5 mg q4h PRN oral, pain scores 7-10: oxycodone 10 mg q4h PRN oral. Discharge: acetaminophen 1 g q8h oral, tramadol 100 mg q8h oral, celecoxib 200 mg q12h oral or meloxicam 15 mg daily oral, oxycodone 5 mg q4h PRN oral. 75 or older: Same except: Preop: celecoxib 200 mg oral. PACU meds: acetaminophen 500 mg oral. No OxyER.

Drug: Acetaminophen; Drug: Celecoxib 200mg; Drug: Celecoxib 400 mg; Drug: Ropivacaine; Drug: Ketorolac; Drug: Acetaminophen Injectable Product; Drug: Oxycodone; Drug: Tramadol; Drug: Meloxicam

Interventions

Acetaminophen DRUG

Acetaminophen Tablet

Also known as: Tylenol

Multimodal Anesthesia and Analgesia

Celecoxib 200mg DRUG

Celecoxib Tablet

Also known as: Celebrex

Multimodal Anesthesia and Analgesia

Celecoxib 400 mg DRUG

Celecoxib Tablet

Also known as: Celebrex

Multimodal Anesthesia and Analgesia

Ropivacaine DRUG

Ropivicaine nerve block (injection)

Multimodal Anesthesia and Analgesia; Traditional (Standard) Protocol

Ketorolac DRUG

ketorolac injection

Also known as: Toradol

Multimodal Anesthesia and Analgesia

Acetaminophen Injectable Product DRUG

Acetaminophen injection

Also known as: Tylenol

Multimodal Anesthesia and Analgesia

Oxycodone DRUG

oxycodone tablet

Also known as: OxyIR

Multimodal Anesthesia and Analgesia

Tramadol DRUG

Tramadol tablet

Also known as: Ultram

Multimodal Anesthesia and Analgesia

Morphine Injectable Solution DRUG

Morphine Patient Controlled Analgesia

Also known as: Morphine

Traditional (Standard) Protocol

hydrocodone bitartrate and acetaminophen DRUG

Norco tablet

Also known as: Norco

Traditional (Standard) Protocol

Morphine DRUG

morphine injection

Traditional (Standard) Protocol

Oxycodone Hydrochloride DRUG

oxycodone hydrochloride tablet

Also known as: Oxycontin, OxyER

Traditional (Standard) Protocol

Meloxicam DRUG

meloxicam tablet

Also known as: mobic

Multimodal Anesthesia and Analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than 18 years of Age, undergoing primary anatomic or reverse total shoulder arthroplasty

You may not qualify if:

• Opioid consumption within 4 weeks prior to surgery, allergy to oxycodone or study drugs, refusal to take oxycodone or study drugs, history of opioid dependence or illegal/"off-label" opioid use, revision arthroplasty procedures

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (7)

• Kim 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.

  PMID: 27869630 BACKGROUND

• Morris BJ, Mir HR. The opioid epidemic: impact on orthopaedic surgery. J Am Acad Orthop Surg. 2015 May;23(5):267-71. doi: 10.5435/JAAOS-D-14-00163.

  PMID: 25911660 BACKGROUND

• Bates C, Laciak R, Southwick A, Bishoff J. Overprescription of postoperative narcotics: a look at postoperative pain medication delivery, consumption and disposal in urological practice. J Urol. 2011 Feb;185(2):551-5. doi: 10.1016/j.juro.2010.09.088. Epub 2010 Dec 18.

  PMID: 21168869 BACKGROUND

• Gaither JR, Leventhal JM, Ryan SA, Camenga DR. National Trends in Hospitalizations for Opioid Poisonings Among Children and Adolescents, 1997 to 2012. JAMA Pediatr. 2016 Dec 1;170(12):1195-1201. doi: 10.1001/jamapediatrics.2016.2154.

  PMID: 27802492 BACKGROUND

• Moreno MA. Page for patients. The misuse of prescription pain medicine among children and teens. JAMA Pediatr. 2015 May;169(5):512. doi: 10.1001/jamapediatrics.2014.2128. No abstract available.

  PMID: 25938654 BACKGROUND

• Della Valle CJ, Dittle E, Moric M, Sporer SM, Buvanendran A. A prospective randomized trial of mini-incision posterior and two-incision total hip arthroplasty. Clin Orthop Relat Res. 2010 Dec;468(12):3348-54. doi: 10.1007/s11999-010-1491-5. Epub 2010 Jul 29.

  PMID: 20668969 BACKGROUND

• Namdari S, Nicholson T, Abboud J, Lazarus M, Steinberg D, Williams G. Randomized Controlled Trial of Interscalene Block Compared with Injectable Liposomal Bupivacaine in Shoulder Arthroplasty. J Bone Joint Surg Am. 2017 Apr 5;99(7):550-556. doi: 10.2106/JBJS.16.00296.

  PMID: 28375887 BACKGROUND

Related Links

• Opioid Addiction Facts and Figures 2016 from the American Society of Addiction Medicine
• Opioid Use, Misuse, and Abuse in Orthopaedic Practice from the American Academy of Orthopaedic Surgeons
• White House Report-Continued Rise in Opioid Overdose Deaths in 2015 Shows Urgent Need for Treatment

MeSH Terms

Conditions

Shoulder Pain

Interventions

Acetaminophen; Celecoxib; Ropivacaine; Ketorolac; Ketorolac Tromethamine; Oxycodone; Tramadol; Morphine; Hydrocodone; oxycodone-acetaminophen; Meloxicam

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Benzenesulfonamides; Sulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids; Thiazines; Thiazoles

Study Officials

• Gregory P Nicholson, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 16, 2018
• Study Start: June 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)