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Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carpal Tunnel Syndrome
Interventions Drug: Acetaminophen
Drug: Vicodin
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vicodin 5/325 mg Acetaminophen 325 mg
Hide Arm/Group Description

Half of the patients will be randomized to Vicodin

Acetaminophen: 325 mg

Half of the patients will be randomized to Acetaminophen

Vicodin: Vicodin 5/325 mg

Period Title: Overall Study
Started 4 3
Completed 4 3
Not Completed 0 0
Arm/Group Title Vicodin 5/325 mg Acetaminophen 325 mg Total
Hide Arm/Group Description

Half of the patients will be randomized to Vicodin

Acetaminophen: 325 mg

Half of the patients will be randomized to Acetaminophen

Vicodin: Vicodin 5/325 mg

Total of all reporting groups
Overall Number of Baseline Participants 4 3 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  75.0%
3
 100.0%
6
  85.7%
>=65 years
1
  25.0%
0
   0.0%
1
  14.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 7 participants
63.8  (7.5) 50  (13.1) 57.9  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
Female
2
  50.0%
2
  66.7%
4
  57.1%
Male
2
  50.0%
1
  33.3%
3
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 3 participants 7 participants
4 3 7
1.Primary Outcome
Title Satisfaction With Pain Relief
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vicodin 5/325 mg Acetaminophen 325 mg
Hide Arm/Group Description:

Half of the patients will be randomized to Vicodin

Acetaminophen: 325 mg

Half of the patients will be randomized to Acetaminophen

Vicodin: Vicodin 5/325 mg

Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.75  (2.75) 6.67  (5.77)
2.Secondary Outcome
Title QuickDASH
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Vicodin 5/325 mg Acetaminophen 325 mg
Hide Arm/Group Description:

Half of the patients will be randomized to Vicodin

Acetaminophen: 325 mg

Half of the patients will be randomized to Acetaminophen

Vicodin: Vicodin 5/325 mg

Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
41.5  (19.51) 33.3  (9.46)
3.Secondary Outcome
Title PSEQ
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vicodin 5/325 mg Acetaminophen 325 mg
Hide Arm/Group Description:

Half of the patients will be randomized to Vicodin

Acetaminophen: 325 mg

Half of the patients will be randomized to Acetaminophen

Vicodin: Vicodin 5/325 mg

Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
41.75  (19.10) 46  (8.7)
4.Secondary Outcome
Title PHQ-9
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vicodin 5/325 mg Acetaminophen 325 mg
Hide Arm/Group Description:

Half of the patients will be randomized to Vicodin

Acetaminophen: 325 mg

Half of the patients will be randomized to Acetaminophen

Vicodin: Vicodin 5/325 mg

Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.5  (5.2) 4.7  (4.2)
5.Secondary Outcome
Title Pain Patients Expect After Surgery
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vicodin 5/325 mg Acetaminophen 325 mg
Hide Arm/Group Description:

Half of the patients will be randomized to Vicodin

Acetaminophen: 325 mg

Half of the patients will be randomized to Acetaminophen

Vicodin: Vicodin 5/325 mg

Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.5  (1.73) 4  (2.65)
6.Secondary Outcome
Title Expectation of Pain Relief
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vicodin 5/325 mg Acetaminophen 325 mg
Hide Arm/Group Description:

Half of the patients will be randomized to Vicodin

Acetaminophen: 325 mg

Half of the patients will be randomized to Acetaminophen

Vicodin: Vicodin 5/325 mg

Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.25  (0.5) 8.33  (1.53)
7.Secondary Outcome
Title Pain Scale
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vicodin 5/325 mg Acetaminophen 325 mg
Hide Arm/Group Description:

Half of the patients will be randomized to Vicodin

Acetaminophen: 325 mg

Half of the patients will be randomized to Acetaminophen

Vicodin: Vicodin 5/325 mg

Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.75  (2.5) 6  (2)
8.Secondary Outcome
Title QuickDASH
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vicodin 5/325 mg Acetaminophen 325 mg
Hide Arm/Group Description:

Half of the patients will be randomized to Vicodin

Acetaminophen: 325 mg

Half of the patients will be randomized to Acetaminophen

Vicodin: Vicodin 5/325 mg

Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
46.0  (19.9) 36.4  (35)
9.Secondary Outcome
Title Pain Scale
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vicodin 5/325 mg Acetaminophen 325 mg
Hide Arm/Group Description:

Half of the patients will be randomized to Vicodin

Acetaminophen: 325 mg

Half of the patients will be randomized to Acetaminophen

Vicodin: Vicodin 5/325 mg

Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.5  (4.12) 1.3  (2.3)
Time Frame 3 years, 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vicodin 5/325 mg Acetaminophen 325 mg
Hide Arm/Group Description

Half of the patients will be randomized to Vicodin

Acetaminophen: 325 mg

Half of the patients will be randomized to Acetaminophen

Vicodin: Vicodin 5/325 mg

All-Cause Mortality
Vicodin 5/325 mg Acetaminophen 325 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vicodin 5/325 mg Acetaminophen 325 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vicodin 5/325 mg Acetaminophen 325 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/3 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Neal Chen, MD
Organization: Massachusetts General Hospital
EMail: nchen1@partners.org
Layout table for additonal information
Responsible Party: David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01588158     History of Changes
Other Study ID Numbers: 2011P001670
First Submitted: April 25, 2012
First Posted: April 30, 2012
Results First Submitted: January 11, 2016
Results First Posted: April 14, 2016
Last Update Posted: March 14, 2017