Carpal Tunnel Release, Distal Radius Fracture, Postoperative Pain
Conditions
Keywords
carpal tunnel syndrome, opioid analgesics, postoperative pain, IV tylenol, IV toradol
Brief summary
The purpose of this study is to determine the efficacy of intra-operative administration of IV tylenol and/or IV toradol in minimizing post-operative pain for carpal tunnel patients and distal radius fracture patients.
Detailed description
The study population will include patients presenting for surgery with carpal tunnel syndrome as well as surgical treatment of distal radius fracture. Patients will be treated intra-operatively with either IV tylenol, IV toradol, both, or neither. All patients will receive the standard post-operative prescriptions for pain management. Daily pain surveys scoring pain from 0-10 will be distributed to the subjects to be filled out over the course of 10 days prior to first post-operative visit, usually 10-14 days later. Number of pain pills used before the first post-operative visit will also be measured. We hypothesize that the effects of intra-operative administration of IV tylenol and/or IV toradol will have a significant effect on decreasing post-operative pain in the first 10 days following distal radius fracture surgeries, with a significant difference in pain described as at least a 2 points on a 0-10 pain scale. We also hypothesize that intra-operative administration of IV tylenol and/or IV toradol will not have such significant effect on decreasing post-operative pain for carpal tunnel release surgery. A secondary aim is to evaluate the post-operative opioid consumption of patients within these treatment groups. We hypothesize that opioid consumption will be decreased in the groups receiving IV tylenol and/or toradol for distal radius fracture surgery compared to the placebo group. We do not expect such a difference for the carpal tunnel release surgery group.
Interventions
DRUGAcetaminophen
DRUGKetorolac Tromethamine
DRUGSaline
Sponsors
John Fowler
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* carpal tunnel release surgery candidates, * distal radius fracture surgery candidates
Exclusion criteria
* under 18 years of age, * pregnant women, * prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain (Pain Scores From 0-10 Scale) | 7 days | This is an ordinal pain scale. The patient picks a number from 0-10 scale every 4 hours for 7 days post-operatively. 0 is no pain, 10 is the worst pain imaginable. Lower scores would be preferable to higher scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption (Number of Pills Taken) | 7 days | Daily opioid consumption assessed as number of pills taken that day, each day for 7 days post-operatively Outcome measure reported below is mean number of opioid pills consumed per day. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IV Tylenol One time intra-operative IV acetaminophen administration
Acetaminophen | 11 |
| IV Toradol One time intra-operative IV ketorolac thromethamine administration
Ketorolac Tromethamine | 11 |
| IV Tylenol/Toradol Combination One time intra-operative IV combination of acetaminophen/ketorolac administration
Acetaminophen
Ketorolac Tromethamine | 11 |
| Saline One time intra-operative 50ml IV normal saline administration
Saline | 11 |
| Total | 44 |
Baseline characteristics
| Characteristic | IV Tylenol | IV Toradol | IV Tylenol/Toradol Combination | Saline | Total |
|---|---|---|---|---|---|
| Age, Continuous | 57 years | 48 years | 43 years | 55 years | 51 years |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 6 Participants | 6 Participants | 28 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 5 Participants | 5 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 |
Outcome results
Primary
Postoperative Pain (Pain Scores From 0-10 Scale)
This is an ordinal pain scale. The patient picks a number from 0-10 scale every 4 hours for 7 days post-operatively. 0 is no pain, 10 is the worst pain imaginable. Lower scores would be preferable to higher scores.
Time frame: 7 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IV Tylenol | Postoperative Pain (Pain Scores From 0-10 Scale) | 2.0 units on a scale |
| IV Toradol | Postoperative Pain (Pain Scores From 0-10 Scale) | 2.9 units on a scale |
| IV Tylenol/Toradol Combination | Postoperative Pain (Pain Scores From 0-10 Scale) | 2.7 units on a scale |
| Saline | Postoperative Pain (Pain Scores From 0-10 Scale) | 2.0 units on a scale |
Secondary
Opioid Consumption (Number of Pills Taken)
Daily opioid consumption assessed as number of pills taken that day, each day for 7 days post-operatively Outcome measure reported below is mean number of opioid pills consumed per day.
Time frame: 7 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IV Tylenol | Opioid Consumption (Number of Pills Taken) | 0.2 pills consumed |
| IV Toradol | Opioid Consumption (Number of Pills Taken) | 0.7 pills consumed |
| IV Tylenol/Toradol Combination | Opioid Consumption (Number of Pills Taken) | 1.0 pills consumed |
| Saline | Opioid Consumption (Number of Pills Taken) | 0.7 pills consumed |