Trial Outcomes & Findings for Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery (NCT NCT01588158)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

7 participants

Primary outcome timeframe

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

Results posted on

2017-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	Vicodin 5/325 mg Half of the patients will be randomized to Vicodin Acetaminophen: 325 mg	Acetaminophen 325 mg Half of the patients will be randomized to Acetaminophen Vicodin: Vicodin 5/325 mg
Overall Study STARTED	4	3
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vicodin 5/325 mg n=4 Participants Half of the patients will be randomized to Vicodin Acetaminophen: 325 mg	Acetaminophen 325 mg n=3 Participants Half of the patients will be randomized to Acetaminophen Vicodin: Vicodin 5/325 mg	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	63.8 years STANDARD_DEVIATION 7.5 • n=5 Participants	50 years STANDARD_DEVIATION 13.1 • n=7 Participants	57.9 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vicodin 5/325 mg n=4 Participants Half of the patients will be randomized to Vicodin Acetaminophen: 325 mg	Acetaminophen 325 mg n=3 Participants Half of the patients will be randomized to Acetaminophen Vicodin: Vicodin 5/325 mg
Satisfaction With Pain Relief	6.75 units on a scale Standard Deviation 2.75	6.67 units on a scale Standard Deviation 5.77

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Vicodin 5/325 mg n=4 Participants Half of the patients will be randomized to Vicodin Acetaminophen: 325 mg	Acetaminophen 325 mg n=3 Participants Half of the patients will be randomized to Acetaminophen Vicodin: Vicodin 5/325 mg
QuickDASH	41.5 units on a scale Standard Deviation 19.51	33.3 units on a scale Standard Deviation 9.46

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vicodin 5/325 mg n=4 Participants Half of the patients will be randomized to Vicodin Acetaminophen: 325 mg	Acetaminophen 325 mg n=3 Participants Half of the patients will be randomized to Acetaminophen Vicodin: Vicodin 5/325 mg
PSEQ	41.75 units on a scale Standard Deviation 19.10	46 units on a scale Standard Deviation 8.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vicodin 5/325 mg n=4 Participants Half of the patients will be randomized to Vicodin Acetaminophen: 325 mg	Acetaminophen 325 mg n=3 Participants Half of the patients will be randomized to Acetaminophen Vicodin: Vicodin 5/325 mg
PHQ-9	6.5 units on a scale Standard Deviation 5.2	4.7 units on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Vicodin 5/325 mg n=4 Participants Half of the patients will be randomized to Vicodin Acetaminophen: 325 mg	Acetaminophen 325 mg n=3 Participants Half of the patients will be randomized to Acetaminophen Vicodin: Vicodin 5/325 mg
Pain Patients Expect After Surgery	3.5 units on a scale Standard Deviation 1.73	4 units on a scale Standard Deviation 2.65

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vicodin 5/325 mg n=4 Participants Half of the patients will be randomized to Vicodin Acetaminophen: 325 mg	Acetaminophen 325 mg n=3 Participants Half of the patients will be randomized to Acetaminophen Vicodin: Vicodin 5/325 mg
Expectation of Pain Relief	8.25 units on a scale Standard Deviation 0.5	8.33 units on a scale Standard Deviation 1.53

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vicodin 5/325 mg n=4 Participants Half of the patients will be randomized to Vicodin Acetaminophen: 325 mg	Acetaminophen 325 mg n=3 Participants Half of the patients will be randomized to Acetaminophen Vicodin: Vicodin 5/325 mg
Pain Scale	4.75 units on a scale Standard Deviation 2.5	6 units on a scale Standard Deviation 2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vicodin 5/325 mg n=4 Participants Half of the patients will be randomized to Vicodin Acetaminophen: 325 mg	Acetaminophen 325 mg n=3 Participants Half of the patients will be randomized to Acetaminophen Vicodin: Vicodin 5/325 mg
QuickDASH	46.0 units on a scale Standard Deviation 19.9	36.4 units on a scale Standard Deviation 35

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vicodin 5/325 mg n=4 Participants Half of the patients will be randomized to Vicodin Acetaminophen: 325 mg	Acetaminophen 325 mg n=3 Participants Half of the patients will be randomized to Acetaminophen Vicodin: Vicodin 5/325 mg
Pain Scale	4.5 units on a scale Standard Deviation 4.12	1.3 units on a scale Standard Deviation 2.3

Adverse Events

Vicodin 5/325 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acetaminophen 325 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Neal Chen, MD

Massachusetts General Hospital

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place