Carpal Tunnel, De Quervain Disease, Ganglion Cyst, Trigger Finger
Conditions
Keywords
Adult, soft-tissue hand surgery
Brief summary
The purpose of this research study is to find out which combination of pain medications following surgery work the best and result in the fewest side effects.
Detailed description
This is a prospective, randomized, double-blind study comparing the efficacy of acetaminophen/hydrocodone (AH) to acetaminophen/ibuprofen (AIBU) in providing adequate post-operative pain relief in elective, soft tissue hand surgery patients.
Interventions
Postoperatively, subjects will be given acetaminophen 500 mg / ibuprofen 400mg every 4 hours, as needed, for one week or until essentially pain-free
Postoperatively, subjects will be given acetaminophen 325 mg / hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free
Sponsors
Alexander Payatakes, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than or equal to 18 * Male or Female (non-pregnant) * Elective, soft tissue hand surgery indicated based on diagnosis made by either clinical exam or diagnostic studies (ie nerve conduction study, EMG) or a combination of the two (carpal tunnel release, trigger finger release, first dorsal compartment release, ganglion cyst excision, second extensor compartment release) * Subjects are capable of giving informed consent
Exclusion criteria
* Allergy to study medication * Any pre-existing pain condition requiring analgesia * Fibromyalgia * Recent upper gastrointestinal bleeding * Coagulopathy (primary or medication-related) * Renal impairment * Liver disease * Pregnancy * Patients who consent to the study but require unexpected admission, including those requiring admission resulting from operative complications, will be excluded before randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Comparison of Pain Intensity Level | 1 week post-operatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Comparison of Pain Relief | 1 week postoperatively | Subjects 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 |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Non-compliance with study meds or diary | 4 | 1 |
Baseline characteristics
| Characteristic | Acetaminophen/Ibuprofen (AIBU) Group | Acetaminophen/Hydrocodone (AH) Group | Total |
|---|---|---|---|
| Age, Continuous | 52 years | 53 years | 53 years |
| Patient Health Questionnaire (PHQ-9) | 1.83 units on a scale (total score) | 2.63 units on a scale (total score) | 2.23 units on a scale (total score) |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 31 |
| other Total, other adverse events | 1 / 34 | 7 / 31 |
| serious Total, serious adverse events | 0 / 34 | 0 / 31 |
Outcome results
Primary
Efficacy Comparison of Pain Intensity Level
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.
Time frame: 1 week post-operatively
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Acetaminophen/Ibuprofen (AIBU) Group | 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) |
| Acetaminophen/Ibuprofen (AIBU) Group | 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) |
| Acetaminophen/Ibuprofen (AIBU) Group | 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) |
| Acetaminophen/Ibuprofen (AIBU) Group | 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) |
| Acetaminophen/Ibuprofen (AIBU) Group | Efficacy Comparison of Pain Intensity Level | Daily average pain intensity levelon PostOp Day 4 | 13.17 score on a scale (0-100, higher = worse) |
| Acetaminophen/Ibuprofen (AIBU) Group | 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) |
| Acetaminophen/Ibuprofen (AIBU) Group | 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) |
| Acetaminophen/Hydrocodone (AH) Group | Efficacy Comparison of Pain Intensity Level | Daily average pain intensity level on PostOp Day 7 | 13.00 score on a scale (0-100, higher = worse) |
| Acetaminophen/Hydrocodone (AH) Group | Efficacy Comparison of Pain Intensity Level | Daily average pain intensity level on PostOp Day 1 | 24.07 score on a scale (0-100, higher = worse) |
| Acetaminophen/Hydrocodone (AH) Group | Efficacy Comparison of Pain Intensity Level | Daily average pain intensity level on PostOp Day 2 | 30.16 score on a scale (0-100, higher = worse) |
| Acetaminophen/Hydrocodone (AH) Group | Efficacy Comparison of Pain Intensity Level | Daily average pain intensity level on PostOp Day 3 | 22.11 score on a scale (0-100, higher = worse) |
| Acetaminophen/Hydrocodone (AH) Group | Efficacy Comparison of Pain Intensity Level | Daily average pain intensity levelon PostOp Day 4 | 18.53 score on a scale (0-100, higher = worse) |
| Acetaminophen/Hydrocodone (AH) Group | Efficacy Comparison of Pain Intensity Level | Daily average pain intensity level on PostOp Day 5 | 16.61 score on a scale (0-100, higher = worse) |
| Acetaminophen/Hydrocodone (AH) Group | Efficacy Comparison of Pain Intensity Level | Daily average pain intensity level on PostOp Day 6 | 13.58 score on a scale (0-100, higher = worse) |
Comparison: Null hypothesis: No difference between groups~Power analysis: A sample size of 16 in each group had an 80% power to detect a difference in means of 10 mm.p-value: 0.24t-test, 2 sided
Secondary
Efficacy Comparison of Pain Relief
Subjects 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
Time frame: 1 week postoperatively
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Acetaminophen/Ibuprofen (AIBU) Group | Efficacy Comparison of Pain Relief | Daily average pain relief on PostOp Day 7 | 2.96 score on a scale (0-3, higher = better) |
| Acetaminophen/Ibuprofen (AIBU) Group | Efficacy Comparison of Pain Relief | Daily average pain relief on PostOp Day 1 | 1.84 score on a scale (0-3, higher = better) |
| Acetaminophen/Ibuprofen (AIBU) Group | Efficacy Comparison of Pain Relief | Daily average pain relief on PostOp Day 2 | 2.27 score on a scale (0-3, higher = better) |
| Acetaminophen/Ibuprofen (AIBU) Group | Efficacy Comparison of Pain Relief | Daily average pain relief on PostOp Day 3 | 2.63 score on a scale (0-3, higher = better) |
| Acetaminophen/Ibuprofen (AIBU) Group | Efficacy Comparison of Pain Relief | Daily average pain relief on PostOp Day 4 | 2.91 score on a scale (0-3, higher = better) |
| Acetaminophen/Ibuprofen (AIBU) Group | Efficacy Comparison of Pain Relief | Daily average pain relief on PostOp Day 5 | 2.88 score on a scale (0-3, higher = better) |
| Acetaminophen/Ibuprofen (AIBU) Group | Efficacy Comparison of Pain Relief | Daily average pain relief on PostOp Day 6 | 2.87 score on a scale (0-3, higher = better) |
| Acetaminophen/Hydrocodone (AH) Group | Efficacy Comparison of Pain Relief | Daily average pain relief on PostOp Day 7 | 2.88 score on a scale (0-3, higher = better) |
| Acetaminophen/Hydrocodone (AH) Group | Efficacy Comparison of Pain Relief | Daily average pain relief on PostOp Day 4 | 2.46 score on a scale (0-3, higher = better) |
| Acetaminophen/Hydrocodone (AH) Group | Efficacy Comparison of Pain Relief | Daily average pain relief on PostOp Day 1 | 1.53 score on a scale (0-3, higher = better) |
| Acetaminophen/Hydrocodone (AH) Group | Efficacy Comparison of Pain Relief | Daily average pain relief on PostOp Day 6 | 2.84 score on a scale (0-3, higher = better) |
| Acetaminophen/Hydrocodone (AH) Group | Efficacy Comparison of Pain Relief | Daily average pain relief on PostOp Day 2 | 1.76 score on a scale (0-3, higher = better) |
| Acetaminophen/Hydrocodone (AH) Group | Efficacy Comparison of Pain Relief | Daily average pain relief on PostOp Day 5 | 2.54 score on a scale (0-3, higher = better) |
| Acetaminophen/Hydrocodone (AH) Group | Efficacy Comparison of Pain Relief | Daily average pain relief on PostOp Day 3 | 2.33 score on a scale (0-3, higher = better) |
Comparison: Null hypothesis: No difference between groupsp-value: 0.06t-test, 2 sided