Trial Outcomes & Findings for Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy (NCT NCT02929589)

Last Updated: 2024-03-26

Results Overview

The primary outcome measure was milligram morphine equivalent units to measure pain intensity difference and total pain relief.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

18 participants

Primary outcome timeframe

60 days post-operation

Results posted on

2024-03-26

Participant Flow

Recruitment stopped at 18/160 as advent of robotic arm surgery made this study obsolete.

Participant milestones

Participant milestones
Measure	Opioid naïve Patients-Group A Group A: Subjects will be prescribed ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days, and 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days. . Ibuprofen: ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days	Opioid naïve Patients-Group B Group B:Subjects will be prescribed 800 milligrams of a placebo pill (containing corn starch) to be taken by mouth every 8 hours as needed for pain and 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days. Placebo: 800 milligrams of a placebo pill (containing corn starch) to be taken by mouth every 8 hours as needed for pain
Overall Study STARTED	11	7
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Opioid naïve Patients-Group A Group A: Subjects will be prescribed ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days, and 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days. . Ibuprofen: ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days	Non-Opioid naïve Patients-Group C Group C: Subjects will be prescribed ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days, in addition to their preferred opioid medication prescription. Ibuprofen + Opioid medication: ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days. 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days	Opioid naïve Patients-Group B Group B:Subjects will be prescribed 800 milligrams of a placebo pill (containing corn starch) to be taken by mouth every 8 hours as needed for pain and 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days. Placebo: 800 milligrams of a placebo pill (containing corn starch) to be taken by mouth every 8 hours as needed for pain	Non-Opioid naïve Patients-Group D Group D: Subjects will be prescribed or advised to continue to take only their preferred current oral opioid prescription (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, or transdermal fentanyl). Opioid Medication: 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days
Overall Study Withdrawal by Subject	1	0	0	0
Overall Study Physician Decision	2	0	0	0

Baseline Characteristics

Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Opioid naïve Patients-Group A n=11 Participants Group A: Subjects will be prescribed ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days, and 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days. . Ibuprofen: ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days	Non-Opioid naïve Patients-Group C Group C: Subjects will be prescribed ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days, in addition to their preferred opioid medication prescription. Ibuprofen + Opioid medication: ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days. 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days	Opioid naïve Patients-Group B n=7 Participants Group B:Subjects will be prescribed 800 milligrams of a placebo pill (containing corn starch) to be taken by mouth every 8 hours as needed for pain and 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days. Placebo: 800 milligrams of a placebo pill (containing corn starch) to be taken by mouth every 8 hours as needed for pain	Non-Opioid naïve Patients-Group D Group D: Subjects will be prescribed or advised to continue to take only their preferred current oral opioid prescription (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, or transdermal fentanyl). Opioid Medication: 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	13 Participants n=21 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	16 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	16 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: 60 days post-operation

Population: No populations were analyzed as study was terminated as obsolete after the development and use of robotic arms during surgery. Any data collected was not analyzed by a biostatistician. Raw data are reported for 15 subjects. 3/15 were screenfails in Group A.

The primary outcome measure was milligram morphine equivalent units to measure pain intensity difference and total pain relief.

Outcome measures

Outcome measures
Measure	Opioid naïve Patients-Group A n=8 Participants Group A: Subjects will be prescribed ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days, and 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days. . Ibuprofen: ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days	Non-Opioid naïve Patients-Group C Group C: Subjects will be prescribed ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days, in addition to their preferred opioid medication prescription. Ibuprofen + Opioid medication: ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days. 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days	Opioid naïve Patients-Group B n=7 Participants Group B:Subjects will be prescribed 800 milligrams of a placebo pill (containing corn starch) to be taken by mouth every 8 hours as needed for pain and 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days. Placebo: 800 milligrams of a placebo pill (containing corn starch) to be taken by mouth every 8 hours as needed for pain	Non-Opioid naïve Patients-Group D Group D: Subjects will be prescribed or advised to continue to take only their preferred current oral opioid prescription (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, or transdermal fentanyl). Opioid Medication: 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days
Total Milligram Morphine Equivalent (MME) Units	72 milligram morphine equivalence units Interval 0.0 to 207.0	—	88 milligram morphine equivalence units Interval 0.0 to 340.0	—

Adverse Events

Opioid naïve Patients-Group A

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Non-Opioid naïve Patients-Group C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Opioid naïve Patients-Group B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-Opioid naïve Patients-Group D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Opioid naïve Patients-Group A n=11 participants at risk Group A: Subjects will be prescribed ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days, and 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days. . Ibuprofen: ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days	Non-Opioid naïve Patients-Group C Group C: Subjects will be prescribed ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days, in addition to their preferred opioid medication prescription. Ibuprofen + Opioid medication: ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days. 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days	Opioid naïve Patients-Group B n=7 participants at risk Group B:Subjects will be prescribed 800 milligrams of a placebo pill (containing corn starch) to be taken by mouth every 8 hours as needed for pain and 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days. Placebo: 800 milligrams of a placebo pill (containing corn starch) to be taken by mouth every 8 hours as needed for pain	Non-Opioid naïve Patients-Group D Group D: Subjects will be prescribed or advised to continue to take only their preferred current oral opioid prescription (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, or transdermal fentanyl). Opioid Medication: 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days
Gastrointestinal disorders Adverse Event	9.1% 1/11 • Number of events 1 • Adverse event data were collected for the duration of the study (screening to 60 days post-operation). Adverse events were collected as long as the subject was enrolled in the study; this depended on when surgeries were scheduled and performed.	— 0/0 • Adverse event data were collected for the duration of the study (screening to 60 days post-operation). Adverse events were collected as long as the subject was enrolled in the study; this depended on when surgeries were scheduled and performed.	0.00% 0/7 • Adverse event data were collected for the duration of the study (screening to 60 days post-operation). Adverse events were collected as long as the subject was enrolled in the study; this depended on when surgeries were scheduled and performed.	— 0/0 • Adverse event data were collected for the duration of the study (screening to 60 days post-operation). Adverse events were collected as long as the subject was enrolled in the study; this depended on when surgeries were scheduled and performed.

Additional Information

Amanda Crawford

MOMMC

Phone: 702-653-3583

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place