Prolonged Multimodal Analgesia for Post-Discharge Pain Control After Primary Total Hip Arthroplasty
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03358888 |
Recruitment Status :
Completed
First Posted : December 2, 2017
Last Update Posted : January 29, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis, Hip | Drug: Multi-modal with as needed opioids Drug: Multi-modal with one week of opioids offered Drug: Standard of Care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 228 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | Prolonged Multimodal Analgesia for Post-Discharge Pain Control After Primary Total Hip Arthroplasty |
Actual Study Start Date : | June 5, 2017 |
Actual Primary Completion Date : | January 22, 2018 |
Actual Study Completion Date : | February 28, 2018 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Standard of Care |
Drug: Standard of Care
This arm follows standard of care post-operative pain management with oxycodone, tramadol, and acetametophin |
Active Comparator: Multi-modal with as needed opioids |
Drug: Multi-modal with as needed opioids
Multi-modal with as needed oxycodone and tramadol provided for break-through pain |
Active Comparator: Multi-modal with one week of opioids offered |
Drug: Multi-modal with one week of opioids offered
Multi-modal with only one week of oxycodone and tramadol provided for emergency pain relief only |
- total opioid consumption [ Time Frame: total consumption calcuated from surgery date through 30 days post-op ]
- Pain [ Time Frame: 30 days post-operative ]Pain as reported by Visual Analog Scale

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients undergoing unilateral, primary cementless THA with underlying diagnosis of osteoarthritis.
- ASA I - III
- Spinal anesthesia
- Male and Female over 18 who are willing and able to provide informed consent
Exclusion Criteria:
- Opioid use within 3 months prior to surgery
- General anesthesia
- Non-english speaking
- ASA IV or greater
- Allergy/contraindications to protocol medications
- Renal insufficiency with Cr > 2.0 or hepatic failure
- Sensory/motor disorder involving the operative limb
- Planned or unplanned discharge to rehab
- Length of stay >3 days
- Revision or conversion THA
- Cigarette smokers

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): NCT03358888
United States, Pennsylvania | |
Rothman Institute | |
Philadelphia, Pennsylvania, United States, 19107 |
Responsible Party: | Rothman Institute Orthopaedics |
ClinicalTrials.gov Identifier: | NCT03358888 |
Other Study ID Numbers: |
2017- Chen |
First Posted: | December 2, 2017 Key Record Dates |
Last Update Posted: | January 29, 2019 |
Last Verified: | January 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Osteoarthritis, Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |