IV vs. Oral Acetaminophen as a Component of Multimodal Analgesia After Total Hip Arthroplasty (IV Tylenol)
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ClinicalTrials.gov Identifier: NCT03020966 |
Recruitment Status :
Completed
First Posted : January 13, 2017
Results First Posted : August 10, 2021
Last Update Posted : August 10, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain, Postoperative Opioid Use | Drug: Acetaminophen | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 154 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | IV vs. Oral Acetaminophen as a Component of Multimodal Analgesia After Total Hip Arthroplasty: a Randomized, Blinded Trial |
Actual Study Start Date : | February 16, 2017 |
Actual Primary Completion Date : | June 16, 2019 |
Actual Study Completion Date : | June 16, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Oral Tylenol
Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo
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Drug: Acetaminophen
Oral acetaminophen, intravenous placebo |
Experimental: Intravenous Tylenol
Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo
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Drug: Acetaminophen
Intravenous acetaminophen, oral placebo |
- Pain With Physical Therapy on Post-operative Day 1 [ Time Frame: 24 hours after the operation (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.
- Opioid Use [ Time Frame: Day of surgery to post-operative day 3 ]Oral morphine equivalents, cumulative, POD 0-3. Recorded in Medication Usage Database.
- Opioid Side Effects [ Time Frame: 24 hours after surgery (Post-operative day 1) ]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.

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- 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
Exclusion criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020966
United States, New York | |
Hospital for Special Surgery | |
New York, New York, United States, 10021 |
Principal Investigator: | Jacques Ya Deau, MD, PhD | Hospital for Special Surgery, New York |
Documents provided by Hospital for Special Surgery, New York:
Responsible Party: | Hospital for Special Surgery, New York |
ClinicalTrials.gov Identifier: | NCT03020966 |
Other Study ID Numbers: |
2016-209 |
First Posted: | January 13, 2017 Key Record Dates |
Results First Posted: | August 10, 2021 |
Last Update Posted: | August 10, 2021 |
Last Verified: | August 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Acetaminophen |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics |