Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery

NCT01588158 | Terminated Phase 4 Results

• 1 other identifier: 2011P001670
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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 That study was repeated prospectively (unpublished) and confirmed that Dutch patients do not feel their pain is undertreated.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

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome; Tylenol; Vicodin; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• QuickDASH

  At enrollment prior to surgery

• PSEQ

  1 day

• PHQ-9

  1 day

• Pain Patients Expect After Surgery

  1 day

• Expectation of Pain Relief

  1 day

Study Arms (2)

Vicodin 5/325 mg

ACTIVE COMPARATOR

Half of the patients will be randomized to Vicodin

Drug: Acetaminophen

Acetaminophen 325 mg

ACTIVE COMPARATOR

Half of the patients will be randomized to Acetaminophen

Drug: Vicodin

Interventions

Acetaminophen DRUG

325 mg

Also known as: Tylenol

Vicodin 5/325 mg

Vicodin DRUG

Vicodin 5/325 mg

Also known as: Hydrocodon/Acetaminophen

Acetaminophen 325 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• All subjects will be competent adults able to consent on their own behalf for surgery and care.
• Carpal tunnel release

You may not qualify if:

• Patients unable to give informed consent
• Non English-speaking subjects
• Patients with hypersensitivity to acetaminophen or hydrocodone
• Patients with chronic alcohol abuse
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Pain

Interventions

Acetaminophen; acetaminophen, hydrocodone drug combination; Hydrocodone

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Neal Chen, MD
• Organization: Massachusetts General Hospital

nchen1@partners.org

Study Officials

• David C Ring, MD PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: April 30, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 14, 2017
• Results First Posted: April 14, 2016

Record last verified: 2017-02

Locations

US (1)