Trial Outcomes & Findings for Post-operative Analgesia in Elective, Soft-tissue Hand Surgery (NCT NCT02029235)
NCT ID: NCT02029235
Last Updated: 2018-12-13
Results Overview
Subjects asked to fill out a patient diary recording their pain intensity level (on 100mm Visual Analog Scale) prior to taking study medication every 4 hours. The daily average pain intensity levels are reported as a score on a scale of 0-100, with higher score meaning worse outcome. The daily average pain levels were assessed daily for 1 week post-operatively, then compared between the 2 groups using a two-group Student's t-test.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
72 participants
Primary outcome timeframe
1 week post-operatively
Results posted on
2018-12-13
Participant Flow
Participants were recruited during clinic visits to discuss elective, soft tissue hand surgery at a single academic medical center between February 2015 and October 2017. The first participant was enrolled in February 2015, and the last participant was enrolled in October 2017.
Seven patients withdrew or were excluded prior to randomization due to cancellation of surgery (3), refusal to participate (3), and a newly diagnosed gastrointestinal ulcer (exclusion criterion) prior to surgery (1).
Participant milestones
| Measure |
Acetaminophen/Ibuprofen (AIBU) Group
Postoperatively, subjects were given:
Acetaminophen 500 mg / Ibuprofen 400 mg every 4 hours, as needed, for one week or until essentially pain-free.
|
Acetaminophen/Hydrocodone (AH) Group
Postoperatively, subjects were given:
Acetaminophen 325 mg / Hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
31
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Acetaminophen/Ibuprofen (AIBU) Group
Postoperatively, subjects were given:
Acetaminophen 500 mg / Ibuprofen 400 mg every 4 hours, as needed, for one week or until essentially pain-free.
|
Acetaminophen/Hydrocodone (AH) Group
Postoperatively, subjects were given:
Acetaminophen 325 mg / Hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free.
|
|---|---|---|
|
Overall Study
Non-compliance with study meds or diary
|
4
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Acetaminophen/Ibuprofen (AIBU) Group
n=30 Participants
Postoperatively, subjects were given:
Acetaminophen 500 mg / Ibuprofen 400 mg every 4 hours, as needed, for one week or until essentially pain-free.
|
Acetaminophen/Hydrocodone (AH) Group
n=30 Participants
Postoperatively, subjects were given:
Acetaminophen 325 mg / Hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
n=30 Participants
|
53 years
n=30 Participants
|
53 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=30 Participants
|
17 Participants
n=30 Participants
|
35 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=30 Participants
|
13 Participants
n=30 Participants
|
25 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
30 participants
n=30 Participants
|
30 participants
n=30 Participants
|
60 participants
n=60 Participants
|
|
Patient Health Questionnaire (PHQ-9)
|
1.83 units on a scale (total score)
n=30 Participants
|
2.63 units on a scale (total score)
n=30 Participants
|
2.23 units on a scale (total score)
n=60 Participants
|
PRIMARY outcome
Timeframe: 1 week post-operativelySubjects asked to fill out a patient diary recording their pain intensity level (on 100mm Visual Analog Scale) prior to taking study medication every 4 hours. The daily average pain intensity levels are reported as a score on a scale of 0-100, with higher score meaning worse outcome. The daily average pain levels were assessed daily for 1 week post-operatively, then compared between the 2 groups using a two-group Student's t-test.
Outcome measures
| Measure |
Acetaminophen/Ibuprofen (AIBU) Group
n=30 Participants
Postoperatively, subjects were given:
Acetaminophen 500 mg / Ibuprofen 400 mg every 4 hours, as needed, for one week or until essentially pain-free.
|
Acetaminophen/Hydrocodone (AH) Group
n=30 Participants
Postoperatively, subjects were given:
Acetaminophen 325 mg / Hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free.
|
|---|---|---|
|
Efficacy Comparison of Pain Intensity Level
Daily average pain intensity level on PostOp Day 2
|
22.22 score on a scale (0-100, higher = worse)
Interval 0.0 to 93.0
|
30.16 score on a scale (0-100, higher = worse)
Interval 0.0 to 95.0
|
|
Efficacy Comparison of Pain Intensity Level
Daily average pain intensity level on PostOp Day 3
|
15.67 score on a scale (0-100, higher = worse)
Interval 0.0 to 75.0
|
22.11 score on a scale (0-100, higher = worse)
Interval 0.0 to 90.0
|
|
Efficacy Comparison of Pain Intensity Level
Daily average pain intensity levelon PostOp Day 4
|
13.17 score on a scale (0-100, higher = worse)
Interval 0.0 to 55.0
|
18.53 score on a scale (0-100, higher = worse)
Interval 0.0 to 90.0
|
|
Efficacy Comparison of Pain Intensity Level
Daily average pain intensity level on PostOp Day 5
|
14.03 score on a scale (0-100, higher = worse)
Interval 0.0 to 67.0
|
16.61 score on a scale (0-100, higher = worse)
Interval 0.0 to 90.0
|
|
Efficacy Comparison of Pain Intensity Level
Daily average pain intensity level on PostOp Day 6
|
13.44 score on a scale (0-100, higher = worse)
Interval 0.0 to 50.0
|
13.58 score on a scale (0-100, higher = worse)
Interval 0.0 to 73.0
|
|
Efficacy Comparison of Pain Intensity Level
Daily average pain intensity level on PostOp Day 7
|
12.67 score on a scale (0-100, higher = worse)
Interval 0.0 to 65.0
|
13.00 score on a scale (0-100, higher = worse)
Interval 0.0 to 63.0
|
|
Efficacy Comparison of Pain Intensity Level
Daily average pain intensity level on PostOp Day 1
|
22.17 score on a scale (0-100, higher = worse)
Interval 0.0 to 100.0
|
24.07 score on a scale (0-100, higher = worse)
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 1 week postoperativelySubjects asked to fill out a patient diary recording their pain relief (on a Likert scale) one hour after taking study medication every 4 hours. Daily average pain relief scores are reported as a score on a scale of 0-3, with higher score meaning better outcome. The daily average pain relief scores were assessed daily for 1 week post-operatively, then compared using generalized linear mixed-effects models
Outcome measures
| Measure |
Acetaminophen/Ibuprofen (AIBU) Group
n=30 Participants
Postoperatively, subjects were given:
Acetaminophen 500 mg / Ibuprofen 400 mg every 4 hours, as needed, for one week or until essentially pain-free.
|
Acetaminophen/Hydrocodone (AH) Group
n=30 Participants
Postoperatively, subjects were given:
Acetaminophen 325 mg / Hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free.
|
|---|---|---|
|
Efficacy Comparison of Pain Relief
Daily average pain relief on PostOp Day 1
|
1.84 score on a scale (0-3, higher = better)
Interval 1.0 to 3.0
|
1.53 score on a scale (0-3, higher = better)
Interval 1.0 to 3.0
|
|
Efficacy Comparison of Pain Relief
Daily average pain relief on PostOp Day 2
|
2.27 score on a scale (0-3, higher = better)
Interval 1.0 to 3.0
|
1.76 score on a scale (0-3, higher = better)
Interval 1.0 to 3.0
|
|
Efficacy Comparison of Pain Relief
Daily average pain relief on PostOp Day 3
|
2.63 score on a scale (0-3, higher = better)
Interval 1.0 to 3.0
|
2.33 score on a scale (0-3, higher = better)
Interval 1.0 to 3.0
|
|
Efficacy Comparison of Pain Relief
Daily average pain relief on PostOp Day 4
|
2.91 score on a scale (0-3, higher = better)
Interval 1.0 to 3.0
|
2.46 score on a scale (0-3, higher = better)
Interval 1.0 to 3.0
|
|
Efficacy Comparison of Pain Relief
Daily average pain relief on PostOp Day 5
|
2.88 score on a scale (0-3, higher = better)
Interval 1.0 to 3.0
|
2.54 score on a scale (0-3, higher = better)
Interval 1.0 to 3.0
|
|
Efficacy Comparison of Pain Relief
Daily average pain relief on PostOp Day 6
|
2.87 score on a scale (0-3, higher = better)
Interval 1.0 to 3.0
|
2.84 score on a scale (0-3, higher = better)
Interval 1.0 to 3.0
|
|
Efficacy Comparison of Pain Relief
Daily average pain relief on PostOp Day 7
|
2.96 score on a scale (0-3, higher = better)
Interval 1.0 to 3.0
|
2.88 score on a scale (0-3, higher = better)
Interval 1.0 to 3.0
|
Adverse Events
Acetaminophen/Ibuprofen (AIBU) Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Acetaminophen/Hydrocodone (AH) Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acetaminophen/Ibuprofen (AIBU) Group
n=34 participants at risk
Acetaminophen 500 mg and Ibuprofen 400 mg
Acetaminophen/Ibuprofen: Postoperatively, subjects will be given acetaminophen 500 mg / ibuprofen 400mg every 4 hours, as needed, for one week or until essentially pain-free
|
Acetaminophen/Hydrocodone (AH) Group
n=31 participants at risk
Acetaminophen 325 mg and Hydrocodone 5 mg
Acetaminophen/Hydrocodone: Postoperatively, subjects will be given acetaminophen 325 mg / hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free
|
|---|---|---|
|
Nervous system disorders
Drowsiness
|
2.9%
1/34 • Number of events 1 • 2 weeks
Definition consistent with those listed on clinicaltrials.gov website. Adverse event collection occurred at postop day 7 phone call, as well as first follow-up clinic-visit.
|
12.9%
4/31 • Number of events 4 • 2 weeks
Definition consistent with those listed on clinicaltrials.gov website. Adverse event collection occurred at postop day 7 phone call, as well as first follow-up clinic-visit.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/34 • 2 weeks
Definition consistent with those listed on clinicaltrials.gov website. Adverse event collection occurred at postop day 7 phone call, as well as first follow-up clinic-visit.
|
9.7%
3/31 • Number of events 3 • 2 weeks
Definition consistent with those listed on clinicaltrials.gov website. Adverse event collection occurred at postop day 7 phone call, as well as first follow-up clinic-visit.
|
|
Skin and subcutaneous tissue disorders
Itchiness
|
0.00%
0/34 • 2 weeks
Definition consistent with those listed on clinicaltrials.gov website. Adverse event collection occurred at postop day 7 phone call, as well as first follow-up clinic-visit.
|
3.2%
1/31 • Number of events 1 • 2 weeks
Definition consistent with those listed on clinicaltrials.gov website. Adverse event collection occurred at postop day 7 phone call, as well as first follow-up clinic-visit.
|
Additional Information
Alexander Payatakes, MD
Penn State Health Milton S. Hershey Medical Center
Phone: 717-531-4805
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place