Multimodal Pain Therapy After Hernia Repair
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|ClinicalTrials.gov Identifier: NCT03792295|
Recruitment Status : Not yet recruiting
First Posted : January 3, 2019
Last Update Posted : July 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hernia, Abdominal Pain||Drug: acetominophen, ibuprofen, oxycodone Drug: Oxycodone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Multimodal Pain Therapy After Hernia Repair|
|Estimated Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||July 1, 2022|
Experimental: Multimodal Therapy
Patients will receive scheduled ibuprofen 400mg po q 4 hours and acetominophen 1gram po q 8 hours during the post operative phase and oxycodone 5mg po q 4 to 6 hours as needed for pain control.
Drug: acetominophen, ibuprofen, oxycodone
Multimodal pain treatment group
Other Name: Tylenol, Advil, OxyContin
Active Comparator: Classic/standard opiod Therapy
Patients will receive oxycodone 5mg po q 4 to 6 hours as needed during their post operative phase for pain control.
Classic opiod pain treatment group
Other Name: OxyContin
- Post operative pain scores at rest and during movement [ Time Frame: 1-14 days after surgery ]
Patients will be called on post operative days 1-3 and asked to rate their pain while at rest and during movement using the following scales:
On a scale of 1-10, with 1=no pain and 10= the worst pain, what has been your average pain level since surgery during REST? 1 2 3 4 5 6 7 8 9 10
On a scale of 1-10, with 1=no pain and 10= the worst pain, what has been your average pain level since surgery during MOVEMENT (such as walking across the room)? 1 2 3 4 5 6 7 8 9 10
Patients will also be asked the same two pain scales (pain at rest and during movement) at the first post-operative appointment, which will occur within 14 days of their surgery.
The scores for pain at rest and during movement will not be summed or averaged together, so that the maximum score on each scale is 10 (worst pain), and the minimum score is 1 (no pain). Scores will not be summed across days. Lower scores are considered a better outcome, and higher scores are considered a worse outcome.
- Narcotic use [ Time Frame: 1-14 days after surgery ]Amount of oxycodone pills taken
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): NCT03792295
|Contact: K Vaziri, MD||(202) email@example.com|
|Contact: Tammy Ju, MDfirstname.lastname@example.org|
|United States, District of Columbia|
|George Washington University Hospital|
|Washington, District of Columbia, United States, 20037|
|Contact: Khashayar Vaziri, MD 202-715-4000 email@example.com|