Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery

Study Overview
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Brief Summary
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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 That study was repeated prospectively (unpublished) and confirmed that Dutch patients do not feel their pain is undertreated.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
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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.

Official Title
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Satisfaction With Pain Relief After Carpal Tunnel Release Surgery

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Drug: Acetaminophen
* Drug: Vicodin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vicodin 5/325 mg<br>Half of the patients will be randomized to Vicodin | Drug: Acetaminophen<br>* 325 mg<br>* Other names: Tylenol;|
| Active Comparator: Acetaminophen 325 mg<br>Half of the patients will be randomized to Acetaminophen | Drug: Vicodin<br>* Vicodin 5/325 mg<br>* Other names: Hydrocodon/Acetaminophen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at the follow-up, 2 weeks after the operation with suture removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At enrollment prior to surgery | 
| 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. | 1 day | 
| 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. | 1 day | 
| 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 | 1 day | 
| 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. | 1 day | 
| 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. | At enrollment prior to surgery | 
| 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. | At the follow-up 2 weeks after the surgery with suture removal | 
| 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. | At the follow-up 2 weeks after the surgery with suture removal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carpal tunnel syndrome, Tylenol, Vicodin, pain