Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery
Primary Purpose
Carpal Tunnel Syndrome
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen
Vicodin
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring carpal tunnel syndrome, Tylenol, Vicodin, pain
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older.
- All subjects will be competent adults able to consent on their own behalf for surgery and care.
- Inclusion prior to surgery
- Carpal tunnel release
Exclusion Criteria:
- Pregnant women. Patients will be queried with the routine preoperative medical history and an inclusion/exclusion checklist.
- Patients unable to give informed consent
- Non English-speaking subjects
- Patients with hypersensitivity to acetaminophen or hydrocodone
- Patients with chronic alcohol abuse
- Patients with severe impairment of renal or hepatic function. This will be assessed in the routine preoperative medical history and review of the medical record. We will also ask the patients specific for this history in the screening for the study inclusion/exclusion criteria.
- Patients with hypothyroidism
- Patients with Addison's disease
- Patients with prostatic hypertrophy or urethral stricture
- Patients using any of the following medications:
MAO or tricyclic antidepressants Antihistaminics Antipsychotic or anti-anxiety medications Phenothiazines Zidovudin Phenobarbital
- Patients who are taking opioid pain medication for another reason prior to surgery.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Vicodin 5/325 mg
Acetaminophen 325 mg
Arm Description
Half of the patients will be randomized to Vicodin
Half of the patients will be randomized to Acetaminophen
Outcomes
Primary Outcome Measures
Satisfaction With Pain Relief
an 11-point ordinal scale to ask for the satisfaction of the patients with pain relief. The scale range is from 0-10, where 0 is complete dissatisfaction with pain relief and 10 is complete satisfaction.
Secondary Outcome Measures
QuickDASH
The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.
PSEQ
The pain self efficacy questionnaire measures a patient's belief about his/her ability to complete a task despite his/her pain. The scale range is from 0-60, where 60 represents higher self-efficacy beliefs.
PHQ-9
Patient Health Questionnaire-9 to assess symptoms of depression. The scale range is from 0-27, where 0 is no symptoms of depression and 27 is severe depression.
Pain Patients Expect After Surgery
an 11-point ordinal scale to assess the amount of pain the patients expect after surgery. The scale range is from 0-10, where 0 is no pain expected and 10 is the worst pain expected
Expectation of Pain Relief
An 11-point ordinal scale to assess the expectation of how well the pain medication will work after surgery. The scale range is from 0-10, where 0 is not effective at all and 10 is completely effective.
Pain Scale
11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had.
QuickDASH
The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.
Pain Scale
11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had.
Full Information
NCT ID
NCT01588158
First Posted
April 25, 2012
Last Updated
February 2, 2017
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01588158
Brief Title
Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery
Official Title
Satisfaction With Pain Relief After Carpal Tunnel Release Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
The PI of this study is leaving the institution and enrollment was progressing slowly so we decided to close the study.
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Adequate pain relief has been a priority of the Joint Commission and is featured on national inpatient surveys such as the H-CAHPS. When considering methods for improving satisfaction with pain relief in the United States, a great deal of emphasis has been placed on opioid pain medications. Some of this emphasis on opioid pain medication is driven by the pharmaceutical industry and by advocacy groups with ties to the pharmaceutical industry.
There is evidence that the "pain is the fifth vital sign" campaign of the Joint Commission led to an increased incidence of prescription of opioids, but there is less evidence of improved satisfaction with pain relief. There is some evidence of an increase in opioid-related adverse events. As the sales of opioids have tripled from 1999-2008, so has the number of deaths caused by opioid overdose; 14,800 in 2008. The number of visits to the Emergency Department for opioid overdose doubled between 2004 and 2008.
Patients in other countries take far less opioid pain medication and are equally satisfied with pain relief. For instance, Lindenhovius et al. found in a retrospective study that Dutch patients take a weak (Tramadol) or no opioid pain medication after ankle fracture surgery and have comparable or better satisfaction with pain relief than American patients, most of whom take oxycodone. That study was repeated prospectively (unpublished) and confirmed that Dutch patients do not feel their pain is undertreated. A study of morphine use after a femur fracture demonstrated that American patients used far more than Vietnamese patients (30 mg/kg versus 0.9 mg/kg), but were more dissatisfied with their pain relief. These sociological differences are striking and suggest strongly that personal factors may be the most important determinant of satisfaction with pain relief.
It is our impression that most American hand surgeons give patients a prescription for an opioid pain medication after carpal tunnel release, and that is certainly true in our practice. This seems to be based primarily on the outliers, and intended to avoid confrontation with patients that desire opioids; however, most patients take little or no narcotic pain medication, and many who do use the opioids complain of the side effects-nausea and pruritis in particular. It is therefore not clear whether routine opioids is the optimal pain management strategy after carpal tunnel release. In the study of Stahl et al. from Israel, patients were prescribed acetaminophen rather than opioids after carpal tunnel release and only 20 of 50 patients used acetaminophen; 30 patients did not use acetaminophen or other pain medication at all after the operation.
Our aim is to determine if there is a difference in satisfaction with pain relief between patients advised to take opioids compared to patients advised to use over the counter acetaminophen after carpal tunnel release under local anesthesia. A secondary aim is to determine if personal factors account for more of the variability in satisfaction with pain relief than opioid strategy.
Detailed Description
Aim:
The specific aim of this study is to compare the effectiveness of Tylenol and Vicodin after carpal tunnel release.
Primary Study Question:
There is no difference in satisfaction with pain relief at the time of suture removal between those advised to use acetaminophen instead of opioids and those give standard advice and a standard prescription for opioids.
Secondary Study Questions/Null Hypotheses:
Psychological and demographic factors do not account for variation in satisfaction with pain relief.
Arm-specific disability does not correlate with use of opioid pain medication.
Overall pain during recovery does not correlate with use of opioid pain medication.
Adequate pain relief has been a priority of the Joint Commission and is featured on national inpatient surveys such as the H-CAHPS. When considering methods for improving satisfaction with pain relief in the United States, a great deal of emphasis has been placed on opioid pain medications. Some of this emphasis on opioid pain medication is driven by the pharmaceutical industry and by advocacy groups with ties to the pharmaceutical industry. For instance 88% of the income of the American Pain Foundation is from industry. It is a consistent finding that although opioid pain improves pain in comparison with placebo, there is no difference in disability or pain relief compared to NSAIDs.
There is evidence that the "pain is the fifth vital sign" campaign of the Joint Commission led to an increased incidence of prescription of opioids, but there is less evidence of improved satisfaction with pain relief. There is some evidence of an increase in opioid-related adverse events. As the sales of opioids have tripled from 1999-2008, so has the number of deaths caused by opioid overdose; 14,800 in 2008. The number of visits to the Emergency Department for opioid overdose doubled between 2004 and 2008.
Patients in other countries take far less opioid pain medication and are equally satisfied with pain relief. For instance, Lindenhovius et al. found in a retrospective study that Dutch patients take a weak (Tramadol) or no opioid pain medication after ankle fracture surgery and have comparable or better satisfaction with pain relief than American patients, most of whom take oxycodone. That study was repeated prospectively (unpublished) and confirmed that Dutch patients do not feel their pain is undertreated. A study of morphine use after a femur fracture demonstrated that American patients used far more than Vietnamese patients (30 mg/kg versus 0.9 mg/kg), but were more dissatisfied with their pain relief. These sociological differences are striking and suggest strongly that personal factors may be the most important determinant of satisfaction with pain relief.
It is our impression that most American hand surgeons give patients a prescription for an opioid pain medication after carpal tunnel release, and that is certainly true in our practice. This seems to be based primarily on the outliers, and intended to avoid confrontation with patients that desire opioids; however, most patients take little or no narcotic pain medication, and many who do use the opioids complain of the side effects-nausea and pruritis in particular. It is therefore not clear whether routine opioids is the optimal pain management strategy after carpal tunnel release. In the study of Stahl et al. from Israel, patients were prescribed acetaminophen rather than opioids after carpal tunnel release and only 20 of 50 patients used acetaminophen; 30 patients did not use acetaminophen or other pain medication at all after the operation.
Our aim is to determine if there is a difference in satisfaction with pain relief between patients advised to take opioids compared to patients advised to use over the counter acetaminophen after carpal tunnel release under local anesthesia. A secondary aim is to determine if personal factors account for more of the variability in satisfaction with pain relief than opioid strategy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
carpal tunnel syndrome, Tylenol, Vicodin, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vicodin 5/325 mg
Arm Type
Active Comparator
Arm Description
Half of the patients will be randomized to Vicodin
Arm Title
Acetaminophen 325 mg
Arm Type
Active Comparator
Arm Description
Half of the patients will be randomized to Acetaminophen
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
325 mg
Intervention Type
Drug
Intervention Name(s)
Vicodin
Other Intervention Name(s)
Hydrocodon/Acetaminophen
Intervention Description
Vicodin 5/325 mg
Primary Outcome Measure Information:
Title
Satisfaction With Pain Relief
Description
an 11-point ordinal scale to ask for the satisfaction of the patients with pain relief. The scale range is from 0-10, where 0 is complete dissatisfaction with pain relief and 10 is complete satisfaction.
Time Frame
at the follow-up, 2 weeks after the operation with suture removal
Secondary Outcome Measure Information:
Title
QuickDASH
Description
The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.
Time Frame
At enrollment prior to surgery
Title
PSEQ
Description
The pain self efficacy questionnaire measures a patient's belief about his/her ability to complete a task despite his/her pain. The scale range is from 0-60, where 60 represents higher self-efficacy beliefs.
Time Frame
1 day
Title
PHQ-9
Description
Patient Health Questionnaire-9 to assess symptoms of depression. The scale range is from 0-27, where 0 is no symptoms of depression and 27 is severe depression.
Time Frame
1 day
Title
Pain Patients Expect After Surgery
Description
an 11-point ordinal scale to assess the amount of pain the patients expect after surgery. The scale range is from 0-10, where 0 is no pain expected and 10 is the worst pain expected
Time Frame
1 day
Title
Expectation of Pain Relief
Description
An 11-point ordinal scale to assess the expectation of how well the pain medication will work after surgery. The scale range is from 0-10, where 0 is not effective at all and 10 is completely effective.
Time Frame
1 day
Title
Pain Scale
Description
11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had.
Time Frame
At enrollment prior to surgery
Title
QuickDASH
Description
The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.
Time Frame
At the follow-up 2 weeks after the surgery with suture removal
Title
Pain Scale
Description
11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had.
Time Frame
At the follow-up 2 weeks after the surgery with suture removal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older.
All subjects will be competent adults able to consent on their own behalf for surgery and care.
Inclusion prior to surgery
Carpal tunnel release
Exclusion Criteria:
Pregnant women. Patients will be queried with the routine preoperative medical history and an inclusion/exclusion checklist.
Patients unable to give informed consent
Non English-speaking subjects
Patients with hypersensitivity to acetaminophen or hydrocodone
Patients with chronic alcohol abuse
Patients with severe impairment of renal or hepatic function. This will be assessed in the routine preoperative medical history and review of the medical record. We will also ask the patients specific for this history in the screening for the study inclusion/exclusion criteria.
Patients with hypothyroidism
Patients with Addison's disease
Patients with prostatic hypertrophy or urethral stricture
Patients using any of the following medications:
MAO or tricyclic antidepressants Antihistaminics Antipsychotic or anti-anxiety medications Phenothiazines Zidovudin Phenobarbital
Patients who are taking opioid pain medication for another reason prior to surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C Ring, MD PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery
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