Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01588158
First received: April 25, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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 That study was repeated prospectively (unpublished) and confirmed that Dutch patients do not feel their pain is undertreated.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


Condition Intervention Phase
Carpal Tunnel Syndrome
Drug: Acetaminophen
Drug: Vicodin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Satisfaction With Pain Relief After Carpal Tunnel Release Surgery

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Satisfaction with pain relief [ Time Frame: at the follow-up, 2 weeks after the operation with suture removal ] [ Designated as safety issue: Yes ]
    an 11-point ordinal scale to ask for the satisfaction of the patients with pain relief


Secondary Outcome Measures:
  • QuickDASH [ Time Frame: At enrollment prior to surgery and at the follow-up 2 weeks after the surgery with suture removal ] [ Designated as safety issue: No ]
    The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability

  • PSEQ [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The pain self efficacy questionnaire

  • PHQ-9 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Patient Health Questionnaire-9 to assess symptoms of depression.

  • pain patients expect after surgery [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    an 11-point ordinal scale to assess the amount of pain the patients expect after surgery

  • expectation of pain relief [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    11-point ordinal pain scale


Estimated Enrollment: 144
Study Start Date: July 2012
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vicodin 5/325 mg
Half of the patients will be randomized to Vicodin
Drug: Acetaminophen
325 mg
Other Name: Tylenol
Active Comparator: Acetaminophen 325 mg
Half of the patients will be randomized to Acetaminophen
Drug: Vicodin
Vicodin 5/325 mg
Other Name: Hydrocodon/Acetaminophen

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588158

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: David C Ring, MD PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: David C. Ring, MD, Associate Professor of Orthopaedic Surgery, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01588158     History of Changes
Other Study ID Numbers: 2011P001670
Study First Received: April 25, 2012
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
carpal tunnel syndrome
Tylenol
Vicodin
pain

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Acetaminophen
Acetaminophen, hydrocodone drug combination
Oxycodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014