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Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01588158
Recruitment Status : Terminated (The PI of this study is leaving the institution and enrollment was progressing slowly so we decided to close the study.)
First Posted : April 30, 2012
Results First Posted : April 14, 2016
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE April 25, 2012
First Posted Date  ICMJE April 30, 2012
Results First Submitted Date  ICMJE January 11, 2016
Results First Posted Date  ICMJE April 14, 2016
Last Update Posted Date March 14, 2017
Study Start Date  ICMJE July 2012
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
Satisfaction With Pain Relief [ Time Frame: at the follow-up, 2 weeks after the operation with suture removal ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 27, 2012)
Satisfaction With Pain Relief [ Time Frame: at the follow-up, 2 weeks after the operation with suture removal ]
an 11-point ordinal scale to ask for the satisfaction of the patients with pain relief
Change History Complete list of historical versions of study NCT01588158 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2017)
  • QuickDASH [ Time Frame: At enrollment prior to surgery ]
    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 [ Time Frame: 1 day ]
    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 [ Time Frame: 1 day ]
    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 [ Time Frame: 1 day ]
    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 [ Time Frame: 1 day ]
    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 [ Time Frame: At enrollment prior to surgery ]
    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 [ Time Frame: At the follow-up 2 weeks after the surgery with suture removal ]
    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 [ Time Frame: At the follow-up 2 weeks after the surgery with suture removal ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2012)
  • QuickDASH [ Time Frame: At enrollment prior to surgery and at the follow-up 2 weeks after the surgery with suture removal ]
    The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability
  • PSEQ [ Time Frame: 1 day ]
    The pain self efficacy questionnaire
  • PHQ-9 [ Time Frame: 1 day ]
    Patient Health Questionnaire-9 to assess symptoms of depression.
  • Pain Patients Expect After Surgery [ Time Frame: 1 day ]
    an 11-point ordinal scale to assess the amount of pain the patients expect after surgery
  • Expectation of Pain Relief [ Time Frame: 1 day ]
    An 11-point ordinal scale to assess the expectation of the patients with pain relief.
  • Pain Scale [ Time Frame: At enrollment prior to surgery and at the follow-up 2 weeks after the surgery with suture removal ]
    11-point ordinal pain scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery
Official Title  ICMJE Satisfaction With Pain Relief After Carpal Tunnel Release Surgery
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:

  1. Psychological and demographic factors do not account for variation in satisfaction with pain relief.
  2. Arm-specific disability does not correlate with use of opioid pain medication.
  3. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carpal Tunnel Syndrome
Intervention  ICMJE
  • Drug: Acetaminophen
    325 mg
    Other Name: Tylenol
  • Drug: Vicodin
    Vicodin 5/325 mg
    Other Name: Hydrocodon/Acetaminophen
Study Arms  ICMJE
  • Active Comparator: Vicodin 5/325 mg
    Half of the patients will be randomized to Vicodin
    Intervention: Drug: Acetaminophen
  • Active Comparator: Acetaminophen 325 mg
    Half of the patients will be randomized to Acetaminophen
    Intervention: Drug: Vicodin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 15, 2016)
7
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2012)
144
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01588158
Other Study ID Numbers  ICMJE 2011P001670
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David C. Ring, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David C Ring, MD PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP