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The purpose of this research study is to find out if taking Acetaminophen with Ibuprofen (e.g. Tylenol + Advil), a non-opioid regimen, provides the same type of pain relief after hand surgery compared to Acetaminophen and codeine (e.g. Tylenol 3), an opioid regimen.
Primary Objective:
To establish, through a randomized control trial, whether post-operative Acetaminophen and Ibuprofen (non-opioid regimen) would provide equivalent post-operative analgesia to ambulatory hand surgery patients compared to Acetaminophen and Codeine (opioid regimen).
Secondary Objective:
To establish whether the opioid versus non-opioid post-operative pain regimen influences patient satisfaction.
Sixty-three patients enrolled for each group (non-opioid and opioid). Approximately 145 patients will be required to achieve complete data for 63 patients in each group (assuming 15% lost to follow-up & failure to comply with study protocol).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen/Ibuprofen | Active Comparator | Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg |
|
| Acetaminophen/Codeine | Active Comparator | Group 2: Acetaminophen 300mg, Codeine 30 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen/Ibuprofen | Drug | After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | To establish, through a randomized control trial, whether post-operative Acetaminophen and Ibuprofen (non-opioid regimen) would provide equivalent post-operative analgesia to ambulatory hand surgery patients compared to Acetaminophen and Codeine (opioid regimen). The pain VAS is a continuous scale where 0=no pain and 10=worst pain imaginable. | Subjects reported pain 3 times a day each day after hand surgery (at dinner time, before going to sleep and in the middle of the night), until post-op appointment (between 4 and 8 days after surgery). The numbers reported are the average daily pain scores |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery-9 (QoR-9). | To establish whether the opioid versus non-opioid post-operative pain regimen influences patient satisfaction through Quality of Recovery (QoR) scores in ambulatory hand surgery. This 9 question survey has a maximum score (best outcome) of 18 and minimum (worst outcome) of 3. The survey was administered over the phone on post-operative day 2. | Postoperative Day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Steinberg, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
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There were 4 patients that were enrolled but did not make it to the randomization stage. 2 patients had liver disease and therefore met exclusion criteria for the study. The other 2 patients did not have surgery.
All patients were recruited between 11/18/15 and 1/10/18 and were identified on the physicians surgery schedule as patients receiving either trigger finger or carpel tunnel surgery.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acetaminophen/Ibuprofen | Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg Acetaminophen/Ibuprofen: After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit |
| FG001 | Acetaminophen/Codeine | Group 2: Acetaminophen 300mg, Codeine 30 mg Acetaminophen/Codeine: After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
144 patients were consented for this study. There were 4 patients that were enrolled but did not make it to the randomization stage and 140 patients were placed into the study. 111 patients completed the study and were included in analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Acetaminophen/Ibuprofen | Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg Acetaminophen/Ibuprofen: After surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit |
| BG001 | Acetaminophen/Codeine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | To establish, through a randomized control trial, whether post-operative Acetaminophen and Ibuprofen (non-opioid regimen) would provide equivalent post-operative analgesia to ambulatory hand surgery patients compared to Acetaminophen and Codeine (opioid regimen). The pain VAS is a continuous scale where 0=no pain and 10=worst pain imaginable. | 111 patients completed the study and their data was included in the analysis | Posted | Mean | Standard Deviation | score on a scale | Subjects reported pain 3 times a day each day after hand surgery (at dinner time, before going to sleep and in the middle of the night), until post-op appointment (between 4 and 8 days after surgery). The numbers reported are the average daily pain scores |
|
Adverse events were collected for the subjects time participating on the study. Participation began on the subject's surgery day and ended at their first clinical visit (6-8 days after surgery).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acetaminophen/Ibuprofen | Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg Acetaminophen/Ibuprofen: After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin Gray | University of Pennsylvania | 215-294-9650 | Benjamin.Gray@uphs.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 4, 2016 | Jan 17, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| C526278 | acetaminophen, codeine drug combination |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Acetaminophen/Codeine | Drug | After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit |
|
|
| Number of Pills Used | From the time of surgery to first clinic visit (post-op day 6 to 8) |
| Withdrawal by Subject |
|
| Felt itchy with assigned medication |
|
| Felt nauseous with assigned medication |
|
Group 2: Acetaminophen 300mg, Codeine 30 mg Acetaminophen/Codeine: After surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| VAS Pain Score | The visual analog scale (VAS) for pain is a patient reported outcome measurement. It is a continuous scale anchored by no pain (0) and worst pain imaginable (10). | Mean | Standard Deviation | units on a scale |
|
| OG001 | Acetaminophen/Codeine | Group 2: Acetaminophen 300mg, Codeine 30 mg Acetaminophen/Codeine: After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit |
|
|
| Secondary | Quality of Recovery-9 (QoR-9). | To establish whether the opioid versus non-opioid post-operative pain regimen influences patient satisfaction through Quality of Recovery (QoR) scores in ambulatory hand surgery. This 9 question survey has a maximum score (best outcome) of 18 and minimum (worst outcome) of 3. The survey was administered over the phone on post-operative day 2. | Of the 111 subjects that completed the study, QoR score was available for 93 participants. | Posted | Mean | Standard Deviation | Scores on a scale | Postoperative Day 2 |
|
|
|
| Secondary | Number of Pills Used | Of the 111 subjects that completed the study, data about how many capsules were used was available for 100 participants. | Posted | Mean | Standard Deviation | Pills | From the time of surgery to first clinic visit (post-op day 6 to 8) |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 32 |
| 70 |
| EG001 | Acetaminophen/Codeine | Group 2: Acetaminophen 300mg, Codeine 30 mg Acetaminophen/Codeine: After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit | 0 | 70 | 0 | 70 | 30 | 70 |
| Constipation | General disorders | Systematic Assessment |
|
| Itchiness | General disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Drowsiness | General disorders | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |