IV vs. Oral Acetaminophen as a Component of Multimodal Analgesia After Total Hip Arthroplasty

NCT03020966 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2016-209
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine how well two different methods of administrating Tylenol reduce pain and improve patient satisfaction after total hip replacement (THR) surgery. The methods of administration are orally, via a pill that is to be swallowed, and intravenously. Our aim is to determine whether oral or intravenous administration of Tylenol will reduce opioid consumption and opioid-related side effects after THR.

Conditions

Pain, Postoperative; Opioid Use

Outcome Measures

Primary Outcomes (3)

• Pain With Physical Therapy on Post-operative Day 1

  Numerical rating scale of pain on a scale of 0-10, with 0 representing the minimum value of no pain and 10, representing the maximum, defined as being pain as bad as imaginable.

  24 hours after the operation (post-operative day 1)

• Opioid Use

  Oral morphine equivalents, cumulative, POD 0-3. Recorded in Medication Usage Database.

  Day of surgery to post-operative day 3

• Opioid Side Effects

  The Opioid-Related Symptom Distress Scale (ORSDS) is a Likert scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. Frequency is rated on a 4-point scale (1= 'Rarely', 4= 'Almost constantly'). Severity is rated on a 4-point scale (1= 'Slightly', 4= 'Very'). Bothersomeness is rated on a 5-point scale (0.8= 'Not at all', 4.0= 'Very much'). The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS score is the average of 12 symptom-specific scores.

  24 hours after surgery (Post-operative day 1)

Study Arms (2)

Oral Tylenol

EXPERIMENTAL

Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo

Drug: Acetaminophen

Intravenous Tylenol

EXPERIMENTAL

Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo

Drug: Acetaminophen

Interventions

Acetaminophen DRUG

Oral acetaminophen, intravenous placebo

Oral Tylenol

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult
• Scheduled for an elective primary THA with a participating surgeon,
• Planned for Combined Spinal Epidural anesthesia (CSE) and Patient Controlled Epidural Analgesia (PCEA)
• English-speaking
• Patients that did not receive pre-operative opioids

You may not qualify if:

• Hepatic or renal insufficiency, as defined by abnormal readings on liver and kidney functioning tests.
• Hypersensitivity or contraindication to protocol medication
• Contraindication for CSE and PCEA
• Incapable to provide consent/answer questions in English
• Revision or urgent surgery
• Receiving Periarticular Injections
• History of opioid use
• Patients on disability or worker's compensation

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Mallinckrodt: collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (9)

• Jules-Elysee KM, Goon AK, Westrich GH, Padgett DE, Mayman DJ, Ranawat AS, Ranawat CS, Lin Y, Kahn RL, Bhagat DD, Goytizolo EA, Ma Y, Reid SC, Curren J, YaDeau JT. Patient-controlled epidural analgesia or multimodal pain regimen with periarticular injection after total hip arthroplasty: a randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am. 2015 May 20;97(10):789-98. doi: 10.2106/JBJS.N.00698.

  PMID: 25995489 BACKGROUND

• Gelotte CK, Auiler JF, Lynch JM, Temple AR, Slattery JT. Disposition of acetaminophen at 4, 6, and 8 g/day for 3 days in healthy young adults. Clin Pharmacol Ther. 2007 Jun;81(6):840-8. doi: 10.1038/sj.clpt.6100121. Epub 2007 Mar 21.

  PMID: 17377528 BACKGROUND

• Singla NK, Parulan C, Samson R, Hutchinson J, Bushnell R, Beja EG, Ang R, Royal MA. Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen. Pain Pract. 2012 Sep;12(7):523-32. doi: 10.1111/j.1533-2500.2012.00556.x. Epub 2012 Apr 24.

  PMID: 22524979 BACKGROUND

• Qi DS, May LG, Zimmerman B, Peng P, Atillasoy E, Brown JD, Cooper SA. A randomized, double-blind, placebo-controlled study of acetaminophen 1000 mg versus acetaminophen 650 mg for the treatment of postsurgical dental pain. Clin Ther. 2012 Dec;34(12):2247-2258.e3. doi: 10.1016/j.clinthera.2012.11.003. Epub 2012 Nov 28.

  PMID: 23200183 BACKGROUND

• Liu SS, Bae JJ, Bieltz M, Wukovits B, Ma Y. A prospective survey of patient-controlled epidural analgesia with bupivacaine and clonidine after total hip replacement: a pre- and postchange comparison with bupivacaine and hydromorphone in 1,000 patients. Anesth Analg. 2011 Nov;113(5):1213-7. doi: 10.1213/ANE.0b013e318228fc8b. Epub 2011 Aug 4.

  PMID: 21821512 BACKGROUND

• Yadeau JT, Liu SS, Rade MC, Marcello D, Liguori GA. Performance characteristics and validation of the Opioid-Related Symptom Distress Scale for evaluation of analgesic side effects after orthopedic surgery. Anesth Analg. 2011 Aug;113(2):369-77. doi: 10.1213/ANE.0b013e31821ae3f7. Epub 2011 Apr 27.

  PMID: 21525182 BACKGROUND

• Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.

  PMID: 2240918 BACKGROUND

• Rade MC, Yadeau JT, Ford C, Reid MC. Postoperative delirium in elderly patients after elective hip or knee arthroplasty performed under regional anesthesia. HSS J. 2011 Jul;7(2):151-6. doi: 10.1007/s11420-011-9195-2. Epub 2011 Feb 11.

  PMID: 22754416 BACKGROUND

• Gordon DB, Polomano RC, Pellino TA, Turk DC, McCracken LM, Sherwood G, Paice JA, Wallace MS, Strassels SA, Farrar JT. Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) for quality improvement of pain management in hospitalized adults: preliminary psychometric evaluation. J Pain. 2010 Nov;11(11):1172-86. doi: 10.1016/j.jpain.2010.02.012. Epub 2010 Apr 18.

  PMID: 20400379 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Jacques Yadeau
• Organization: Hospital for Special Surgery

Yadeauj@hss.edu

(212) 774-2224

Study Officials

• Jacques Ya Deau, MD, PhD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: January 13, 2017
• Study Start: February 16, 2017
• Primary Completion: June 16, 2019
• Study Completion: June 16, 2019
• Last Updated: August 10, 2021
• Results First Posted: August 10, 2021

Record last verified: 2021-08

Locations

US (1)