Trial Outcomes & Findings for Continuous Local Anesthetic Infusion Following Hernia Repair (NCT NCT01804114)

Results Overview

Patients will self-report pain assessments on questionnaires each of the first seven days post-operatively using the 4 Point Verbal Rating Scale; ranging from 1=Severe Pain, to 4=No Pain, higher scores indicating less pain, or a better outcome. Values for two daily scores were averaged for each participant, the average across 7 days is reported.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

Verbal Rating Scale used twice a day, up to 7 days postoperatively

Results posted on

2021-01-29

Participant Flow

Two subjects were enrolled and withdrawn prior to assignment of arm/group because their surgeries were converted from laparoscopic to open.

Participant milestones

Participant milestones
Measure	Local Anesthetic Continuous Infusion Pain management following hernia repair Pain management following hernia repair: Continuous infusion of local anesthetic via pain pump following hernia repair	Placebo Continuous Infusion Placebo pain management following hernia repair Placebo for pain management following hernia repair: Continuous infusion of placebo via pain pump following hernia repair
Overall Study STARTED	17	12
Overall Study COMPLETED	17	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous Local Anesthetic Infusion Following Hernia Repair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Local Anesthetic Continuous Infusion n=17 Participants Pain management following hernia repair Pain management following hernia repair: Continuous infusion of local anesthetic via pain pump following hernia repair	Placebo Continuous Infusion n=12 Participants Placebo pain management following hernia repair Placebo for pain management following hernia repair: Continuous infusion of placebo via pain pump following hernia repair	Total n=29 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	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Continuous	60.1 years STANDARD_DEVIATION 12.2 • n=5 Participants	60.9 years STANDARD_DEVIATION 9.1 • n=7 Participants	60.4 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	12 participants n=7 Participants	29 participants n=5 Participants

PRIMARY outcome

Timeframe: Verbal Rating Scale used twice a day, up to 7 days postoperatively

Population: A verbal rating scale was used to collect self-reported outcomes; higher numbers indicated less pain.

Patients will self-report pain assessments on questionnaires each of the first seven days post-operatively using the 4 Point Verbal Rating Scale; ranging from 1=Severe Pain, to 4=No Pain, higher scores indicating less pain, or a better outcome. Values for two daily scores were averaged for each participant, the average across 7 days is reported.

Outcome measures

Outcome measures
Measure	Local Anesthetic Continuous Infusion n=17 Participants Pain management following hernia repair Pain management following hernia repair: Continuous infusion of local anesthetic via pain pump following hernia repair	Placebo Continuous Infusion n=12 Participants Placebo pain management following hernia repair Placebo for pain management following hernia repair: Continuous infusion of placebo via pain pump following hernia repair
Post-Operative Pain	2.91 score on a scale Standard Deviation .05	2.1 score on a scale Standard Deviation .05

SECONDARY outcome

Timeframe: Up to 3 weeks post surgery

Population: Subjects recorded days of postoperative narcotics used after discharge (this supplemented pump infusion). Of the total 29 receiving continuous infusion, 13 anesthetic infusion subjects completed the Post Operative Narcotic Analgesic Use Diary, and 8 placebo subjects completed this diary.

Patients given a diary to record all narcotics taken post-op for pain control.

Outcome measures

Outcome measures
Measure	Local Anesthetic Continuous Infusion n=13 Participants Pain management following hernia repair Pain management following hernia repair: Continuous infusion of local anesthetic via pain pump following hernia repair	Placebo Continuous Infusion n=8 Participants Placebo pain management following hernia repair Placebo for pain management following hernia repair: Continuous infusion of placebo via pain pump following hernia repair
Number of Days With Post-Operative Narcotic Analgesic Use	1 Days Interval 1.0 to 4.0	3 Days Interval 1.0 to 15.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Satisfaction scores reported twice daily for up to the 7th day postoperatively

Population: Subjects reported satisfaction of postoperative pain management on a range of 1-10; higher scores indicate less pain and greater satisfaction. The outcome is an average of 7 days of self-reported scores. Of the 17 subjects receiving continuous infusion of local anesthetic, 11 completed this questionnaire, and 6 of the 12 placebo subjects completed this questionnaire.

Subjects report satisfaction with how pain is managed for the first 7 days postoperatively, on a Numerical Rating Scale of 1-10; higher scores indicate less pain and greater satisfaction. Two daily scores were averaged to compute a single value for each day.

Outcome measures

Outcome measures
Measure	Local Anesthetic Continuous Infusion n=11 Participants Pain management following hernia repair Pain management following hernia repair: Continuous infusion of local anesthetic via pain pump following hernia repair	Placebo Continuous Infusion n=6 Participants Placebo pain management following hernia repair Placebo for pain management following hernia repair: Continuous infusion of placebo via pain pump following hernia repair
Satisfaction With PostOperative Pain Management	8.3 units on a scale Standard Error .4	9 units on a scale Standard Error .5

Adverse Events

Local Anesthetic Continuous Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Continuous Infusion

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

Michael Ujiki, MD

NSUHS

Phone: 8475701700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place