Trial Outcomes & Findings for Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder Functional Outcomes (NCT NCT02588027)

NCT ID: NCT02588027

Last Updated: 2024-12-06

Results Overview

pain control

Recruitment status

COMPLETED

Study phase

Target enrollment

110 participants

Primary outcome timeframe

1 week post operative

Results posted on

2024-12-06

Participant Flow

Participant milestones

Participant milestones
Measure	Ibuprofen Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Ibuprofen: Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator.	Placebo Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Placebo: Pharmacy formulated placebo
Overall Study STARTED	56	54
Overall Study COMPLETED	51	50
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Ibuprofen Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Ibuprofen: Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator.	Placebo Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Placebo: Pharmacy formulated placebo
Overall Study Withdrawal by Subject	1	3
Overall Study Protocol Violation	4	1

Baseline Characteristics

Data missing as some patient's did not answer questions regarding hand dominance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ibuprofen n=51 Participants Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Ibuprofen: Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator.	Placebo n=50 Participants Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Placebo: Pharmacy formulated placebo	Total n=101 Participants Total of all reporting groups
Age, Continuous	57.7 years STANDARD_DEVIATION 10.8 • n=5 Participants	56.9 years STANDARD_DEVIATION 13.8 • n=7 Participants	57.3 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Race/Ethnicity, Customized White	32 Participants n=5 Participants	34 Participants n=7 Participants	66 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Other	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants	50 participants n=7 Participants	101 participants n=5 Participants
Preoperative NSAID Use Ibuprofen	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Preoperative NSAID Use Naproxen	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Preoperative NSAID Use Celecoxib	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Preoperative NSAID Use Other	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Preoperative Opioid Use Norco	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Preoperative Opioid Use Percocet	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Preoperative Opioid Use Oxycodone	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Preoperative Opioid Use Morphine	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Preoperative Opioid Use Hydromorphone	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Prior Shoulder Cortisone Injection	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Shoulder Involved Right	27 Participants n=5 Participants	31 Participants n=7 Participants	58 Participants n=5 Participants
Shoulder Involved Left	24 Participants n=5 Participants	19 Participants n=7 Participants	43 Participants n=5 Participants
Hand Dominance Right	46 Participants n=5 Participants • Data missing as some patient's did not answer questions regarding hand dominance	45 Participants n=7 Participants • Data missing as some patient's did not answer questions regarding hand dominance	91 Participants n=5 Participants • Data missing as some patient's did not answer questions regarding hand dominance
Hand Dominance Left	2 Participants n=5 Participants • Data missing as some patient's did not answer questions regarding hand dominance	4 Participants n=7 Participants • Data missing as some patient's did not answer questions regarding hand dominance	6 Participants n=5 Participants • Data missing as some patient's did not answer questions regarding hand dominance
Hand Dominance Data missing	3 Participants n=5 Participants • Data missing as some patient's did not answer questions regarding hand dominance	1 Participants n=7 Participants • Data missing as some patient's did not answer questions regarding hand dominance	4 Participants n=5 Participants • Data missing as some patient's did not answer questions regarding hand dominance
Surgical Side Dominant	24 Participants n=5 Participants • Some patients did not answer the question regarding hand dominance therefore there are missing data points	30 Participants n=7 Participants • Some patients did not answer the question regarding hand dominance therefore there are missing data points	54 Participants n=5 Participants • Some patients did not answer the question regarding hand dominance therefore there are missing data points
Surgical Side Non-Dominant	24 Participants n=5 Participants • Some patients did not answer the question regarding hand dominance therefore there are missing data points	19 Participants n=7 Participants • Some patients did not answer the question regarding hand dominance therefore there are missing data points	43 Participants n=5 Participants • Some patients did not answer the question regarding hand dominance therefore there are missing data points
Surgical Side Data missing	3 Participants n=5 Participants • Some patients did not answer the question regarding hand dominance therefore there are missing data points	1 Participants n=7 Participants • Some patients did not answer the question regarding hand dominance therefore there are missing data points	4 Participants n=5 Participants • Some patients did not answer the question regarding hand dominance therefore there are missing data points
Size of Rotator Cuff Tear Small	21 Participants n=5 Participants • One patient in the ibuprofen group did not have their tear size categorized by the treating surgeon therefore data point is missing	19 Participants n=7 Participants • One patient in the ibuprofen group did not have their tear size categorized by the treating surgeon therefore data point is missing	40 Participants n=5 Participants • One patient in the ibuprofen group did not have their tear size categorized by the treating surgeon therefore data point is missing
Size of Rotator Cuff Tear Medium	23 Participants n=5 Participants • One patient in the ibuprofen group did not have their tear size categorized by the treating surgeon therefore data point is missing	24 Participants n=7 Participants • One patient in the ibuprofen group did not have their tear size categorized by the treating surgeon therefore data point is missing	47 Participants n=5 Participants • One patient in the ibuprofen group did not have their tear size categorized by the treating surgeon therefore data point is missing
Size of Rotator Cuff Tear Large	3 Participants n=5 Participants • One patient in the ibuprofen group did not have their tear size categorized by the treating surgeon therefore data point is missing	6 Participants n=7 Participants • One patient in the ibuprofen group did not have their tear size categorized by the treating surgeon therefore data point is missing	9 Participants n=5 Participants • One patient in the ibuprofen group did not have their tear size categorized by the treating surgeon therefore data point is missing
Size of Rotator Cuff Tear Massive	3 Participants n=5 Participants • One patient in the ibuprofen group did not have their tear size categorized by the treating surgeon therefore data point is missing	1 Participants n=7 Participants • One patient in the ibuprofen group did not have their tear size categorized by the treating surgeon therefore data point is missing	4 Participants n=5 Participants • One patient in the ibuprofen group did not have their tear size categorized by the treating surgeon therefore data point is missing
Size of Rotator Cuff Tear Data missing	1 Participants n=5 Participants • One patient in the ibuprofen group did not have their tear size categorized by the treating surgeon therefore data point is missing	0 Participants n=7 Participants • One patient in the ibuprofen group did not have their tear size categorized by the treating surgeon therefore data point is missing	1 Participants n=5 Participants • One patient in the ibuprofen group did not have their tear size categorized by the treating surgeon therefore data point is missing
Tendons Torn Supraspinatus	40 Participants n=5 Participants	42 Participants n=7 Participants	82 Participants n=5 Participants
Tendons Torn Infraspinatus	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
Tendons Torn Teres Minor	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Tendons Torn Subscapularis	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Biceps Tenotomy	6 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants
Repair Technique Single Row	33 Participants n=5 Participants • repair techniques were not document by the treating surgeon for 5 patients in the ibuprofen group and 3 patients in the placebo group therefore these data points are missing	33 Participants n=7 Participants • repair techniques were not document by the treating surgeon for 5 patients in the ibuprofen group and 3 patients in the placebo group therefore these data points are missing	66 Participants n=5 Participants • repair techniques were not document by the treating surgeon for 5 patients in the ibuprofen group and 3 patients in the placebo group therefore these data points are missing
Repair Technique Double Row	13 Participants n=5 Participants • repair techniques were not document by the treating surgeon for 5 patients in the ibuprofen group and 3 patients in the placebo group therefore these data points are missing	14 Participants n=7 Participants • repair techniques were not document by the treating surgeon for 5 patients in the ibuprofen group and 3 patients in the placebo group therefore these data points are missing	27 Participants n=5 Participants • repair techniques were not document by the treating surgeon for 5 patients in the ibuprofen group and 3 patients in the placebo group therefore these data points are missing
Repair Technique Data missing	5 Participants n=5 Participants • repair techniques were not document by the treating surgeon for 5 patients in the ibuprofen group and 3 patients in the placebo group therefore these data points are missing	3 Participants n=7 Participants • repair techniques were not document by the treating surgeon for 5 patients in the ibuprofen group and 3 patients in the placebo group therefore these data points are missing	8 Participants n=5 Participants • repair techniques were not document by the treating surgeon for 5 patients in the ibuprofen group and 3 patients in the placebo group therefore these data points are missing

PRIMARY outcome

Timeframe: 1 week post operative

pain control

Outcome measures

Outcome measures
Measure	Ibuprofen n=51 Participants Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Ibuprofen: Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator.	Placebo n=50 Participants Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Placebo: Pharmacy formulated placebo
Opiate Consumption in Patients Prescribed Ibuprofen Versus Placebo	168.3 morphine milligram equivalents Standard Deviation 96	210.9 morphine milligram equivalents Standard Deviation 104

SECONDARY outcome

Timeframe: Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op

Population: The number of patients analyzed at the different times points vary from row to row and do not match the overall number of patients in the study due to lost to follow-up of patients over course of study. Several attempts through various means (ie: phone call, email, mail, etc) to reach patients to collect the data were unsuccessful

American Shoulder Elbow Surgery Score (ASES) - This is a patient reported outcomes score based on a series of questions. The ASES is a 100-point scale that consists of two subscores -- activity of daily living (ADL) and pain visual analog scale (VAS) -- but is reported as one overall score. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. The minimum score is 0 and the maximum score is 100. The higher the score, the better the outcome, indicating better shoulder function (i.e., less pain and better ability to perform daily activities).

Outcome measures

Outcome measures
Measure	Ibuprofen n=51 Participants Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Ibuprofen: Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator.	Placebo n=48 Participants Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Placebo: Pharmacy formulated placebo
Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES) 6 weeks	54.6 score on a scale Standard Deviation 15.5	54 score on a scale Standard Deviation 14.7
Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES) 3 months	69.4 score on a scale Standard Deviation 18.2	69.3 score on a scale Standard Deviation 15.9
Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES) 6 months	86.1 score on a scale Standard Deviation 12.1	78.1 score on a scale Standard Deviation 17.4
Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES) 1 year	93.4 score on a scale Standard Deviation 8.1	90.9 score on a scale Standard Deviation 11.2
Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES) Preoperative	57.8 score on a scale Standard Deviation 21.1	56.2 score on a scale Standard Deviation 20.7

SECONDARY outcome

Timeframe: preop, 1 year postop

The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. A lower score means a better outcome

Outcome measures

Outcome measures
Measure	Ibuprofen n=50 Participants Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Ibuprofen: Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator.	Placebo n=49 Participants Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Placebo: Pharmacy formulated placebo
Assessment of Functional Shoulder Outcome Score: DASH preoperative	62.6 score on a scale Standard Deviation 20.4	62.3 score on a scale Standard Deviation 18.1
Assessment of Functional Shoulder Outcome Score: DASH 1 year	31.9 score on a scale Standard Deviation 8.8	36.4 score on a scale Standard Deviation 13.6

SECONDARY outcome

Timeframe: Preop, 1 year post/op

The SF-12 (12-item short form health survey) is a general HRQoL survey that measures general health status in 8 domains (physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Each score ranges from 0 to 100, with higher scores indicating better physical and mental health functioning.

Outcome measures

Outcome measures
Measure	Ibuprofen n=50 Participants Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Ibuprofen: Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator.	Placebo n=50 Participants Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Placebo: Pharmacy formulated placebo
Assessment of Functional Shoulder Outcome Score: SF-12 Sf-12 MCS 1 year	53 score on a scale Standard Deviation 9.5	51.3 score on a scale Standard Deviation 11.8
Assessment of Functional Shoulder Outcome Score: SF-12 SF-12 PCS preoperative	42.3 score on a scale Standard Deviation 10.3	40.3 score on a scale Standard Deviation 9.4
Assessment of Functional Shoulder Outcome Score: SF-12 SF-12 PCS 1 year	52.5 score on a scale Standard Deviation 5.8	49.4 score on a scale Standard Deviation 9.6
Assessment of Functional Shoulder Outcome Score: SF-12 SF-12 MCS preoperative	51.2 score on a scale Standard Deviation 9.5	50.1 score on a scale Standard Deviation 11.7

SECONDARY outcome

Timeframe: 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op

Pain scale from 0 (no pain) - 10 (worst)

Outcome measures

Outcome measures
Measure	Ibuprofen n=49 Participants Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Ibuprofen: Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator.	Placebo n=50 Participants Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Placebo: Pharmacy formulated placebo
Post Operative Pain Score (Visual Analog Scale) 6 weeks	2.1 score on a scale Standard Deviation 2.0	2.5 score on a scale Standard Deviation 2.1
Post Operative Pain Score (Visual Analog Scale) 3 months	1.8 score on a scale Standard Deviation 1.9	1.8 score on a scale Standard Deviation 1.9
Post Operative Pain Score (Visual Analog Scale) 6 months	0.9 score on a scale Standard Deviation 1.1	1.3 score on a scale Standard Deviation 1.5
Post Operative Pain Score (Visual Analog Scale) 1 year	0.4 score on a scale Standard Deviation 0.8	0.7 score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op

Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees

Outcome measures

Outcome measures
Measure	Ibuprofen n=50 Participants Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Ibuprofen: Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator.	Placebo n=50 Participants Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Placebo: Pharmacy formulated placebo
Range of Motion - Forward Flexion 1 year	168 degrees Standard Deviation 16	164 degrees Standard Deviation 17
Range of Motion - Forward Flexion Preoperative	137 degrees Standard Deviation 39	133 degrees Standard Deviation 40
Range of Motion - Forward Flexion 6 weeks	92 degrees Standard Deviation 29	96 degrees Standard Deviation 35
Range of Motion - Forward Flexion 3 months	142 degrees Standard Deviation 19	138 degrees Standard Deviation 30
Range of Motion - Forward Flexion 6 months	162 degrees Standard Deviation 14	153 degrees Standard Deviation 22

SECONDARY outcome

Timeframe: preoperative, 6 weeks, 3 months, 6 months, 1 year

Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees

Outcome measures

Outcome measures
Measure	Ibuprofen n=48 Participants Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Ibuprofen: Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator.	Placebo n=50 Participants Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Placebo: Pharmacy formulated placebo
Range of Motion - Abduction Preoperative	133 degrees Standard Deviation 41	125.2 degrees Standard Deviation 46
Range of Motion - Abduction 6 weeks	73 degrees Standard Deviation 25	76.7 degrees Standard Deviation 37
Range of Motion - Abduction 3 months	131 degrees Standard Deviation 30	132.8 degrees Standard Deviation 39
Range of Motion - Abduction 6 months	164 degrees Standard Deviation 21	151.6 degrees Standard Deviation 33
Range of Motion - Abduction 1 year	164 degrees Standard Deviation 24	161.8 degrees Standard Deviation 20

SECONDARY outcome

Timeframe: preoperative, 6 weeks, 3 months, 6 months, 1 year

Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees

Outcome measures

Outcome measures
Measure	Ibuprofen n=49 Participants Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Ibuprofen: Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator.	Placebo n=50 Participants Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Placebo: Pharmacy formulated placebo
Range of Motion - External Rotation at Side 6 months	62 degrees Standard Deviation 14	57 degrees Standard Deviation 18
Range of Motion - External Rotation at Side 1 year	67 degrees Standard Deviation 16	65 degrees Standard Deviation 17
Range of Motion - External Rotation at Side preoperative	58 degrees Standard Deviation 18	59.7 degrees Standard Deviation 18
Range of Motion - External Rotation at Side 6 weeks	35 degrees Standard Deviation 13.4	36 degrees Standard Deviation 17
Range of Motion - External Rotation at Side 3 months	51 degrees Standard Deviation 16	56 degrees Standard Deviation 17

SECONDARY outcome

Timeframe: preoperative, 6 weeks, 3 months, 6 months, 1 year

Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees

Outcome measures

Outcome measures
Measure	Ibuprofen n=46 Participants Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Ibuprofen: Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator.	Placebo n=48 Participants Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Placebo: Pharmacy formulated placebo
Range of Motion - External Rotation at 90 Degrees Abduction Preoperative	68 degrees Standard Deviation 24	68 degrees Standard Deviation 29
Range of Motion - External Rotation at 90 Degrees Abduction 6 weeks	42 degrees Standard Deviation 18	42 degrees Standard Deviation 26
Range of Motion - External Rotation at 90 Degrees Abduction 3 months	69 degrees Standard Deviation 16	68 degrees Standard Deviation 17
Range of Motion - External Rotation at 90 Degrees Abduction 6 months	78 degrees Standard Deviation 13	76 degrees Standard Deviation 14
Range of Motion - External Rotation at 90 Degrees Abduction 1 year	83 degrees Standard Deviation 12	81 degrees Standard Deviation 12

Adverse Events

Ibuprofen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jennifer Tangtiphaiboontana

University of California, San Francisco

Phone: 5622095440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place