Skip to content

Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery

Satisfaction With Pain Relief After Carpal Tunnel Release Surgery

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01588158
Enrollment
7
Registered
2012-04-30
Start date
2012-07-31
Completion date
2016-01-31
Last updated
2017-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome, Tylenol, Vicodin, pain

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 That study was repeated prospectively (unpublished) and confirmed that Dutch patients do not feel their pain is undertreated.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

Interventions

DRUGAcetaminophen

325 mg

Vicodin 5/325 mg

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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/

Design outcomes

Primary

MeasureTime frameDescription
Satisfaction With Pain Reliefat the follow-up, 2 weeks after the operation with suture removalan 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

MeasureTime frameDescription
PSEQ1 dayThe 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-91 dayPatient 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.
QuickDASHAt enrollment prior to surgeryThe 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.
Expectation of Pain Relief1 dayAn 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 ScaleAt enrollment prior to surgery11-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.
Pain Patients Expect After Surgery1 dayan 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

Countries

United States

Participant flow

Participants by arm

ArmCount
Vicodin 5/325 mg
Half of the patients will be randomized to Vicodin Acetaminophen: 325 mg
4
Acetaminophen 325 mg
Half of the patients will be randomized to Acetaminophen Vicodin: Vicodin 5/325 mg
3
Total7

Baseline characteristics

CharacteristicAcetaminophen 325 mgVicodin 5/325 mgTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants1 Participants1 Participants
Age, Categorical
Between 18 and 65 years
3 Participants3 Participants6 Participants
Age, Continuous50 years
STANDARD_DEVIATION 13.1
63.8 years
STANDARD_DEVIATION 7.5
57.9 years
STANDARD_DEVIATION 11.8
Region of Enrollment
United States
3 participants4 participants7 participants
Sex: Female, Male
Female
2 Participants2 Participants4 Participants
Sex: Female, Male
Male
1 Participants2 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 40 / 3
serious
Total, serious adverse events
0 / 40 / 3

Outcome results

Primary

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.

Time frame: at the follow-up, 2 weeks after the operation with suture removal

ArmMeasureValue (MEAN)Dispersion
Vicodin 5/325 mgSatisfaction With Pain Relief6.75 units on a scaleStandard Deviation 2.75
Acetaminophen 325 mgSatisfaction With Pain Relief6.67 units on a scaleStandard Deviation 5.77
Secondary

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.

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
Vicodin 5/325 mgExpectation of Pain Relief8.25 units on a scaleStandard Deviation 0.5
Acetaminophen 325 mgExpectation of Pain Relief8.33 units on a scaleStandard Deviation 1.53
Secondary

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

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
Vicodin 5/325 mgPain Patients Expect After Surgery3.5 units on a scaleStandard Deviation 1.73
Acetaminophen 325 mgPain Patients Expect After Surgery4 units on a scaleStandard Deviation 2.65
Secondary

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.

Time frame: At enrollment prior to surgery

ArmMeasureValue (MEAN)Dispersion
Vicodin 5/325 mgPain Scale4.75 units on a scaleStandard Deviation 2.5
Acetaminophen 325 mgPain Scale6 units on a scaleStandard Deviation 2
Secondary

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.

Time frame: At the follow-up 2 weeks after the surgery with suture removal

ArmMeasureValue (MEAN)Dispersion
Vicodin 5/325 mgPain Scale4.5 units on a scaleStandard Deviation 4.12
Acetaminophen 325 mgPain Scale1.3 units on a scaleStandard Deviation 2.3
Secondary

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.

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
Vicodin 5/325 mgPHQ-96.5 units on a scaleStandard Deviation 5.2
Acetaminophen 325 mgPHQ-94.7 units on a scaleStandard Deviation 4.2
Secondary

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.

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
Vicodin 5/325 mgPSEQ41.75 units on a scaleStandard Deviation 19.1
Acetaminophen 325 mgPSEQ46 units on a scaleStandard Deviation 8.7
Secondary

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.

Time frame: At enrollment prior to surgery

Population: Due to early termination of the study, the participants were not analyzed so we do not have data to enter in the outcome measure data table.

ArmMeasureValue (MEAN)Dispersion
Vicodin 5/325 mgQuickDASH41.5 units on a scaleStandard Deviation 19.51
Acetaminophen 325 mgQuickDASH33.3 units on a scaleStandard Deviation 9.46
Secondary

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.

Time frame: At the follow-up 2 weeks after the surgery with suture removal

ArmMeasureValue (MEAN)Dispersion
Vicodin 5/325 mgQuickDASH46.0 units on a scaleStandard Deviation 19.9
Acetaminophen 325 mgQuickDASH36.4 units on a scaleStandard Deviation 35

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026