Trial Outcomes & Findings for Intraperitoneal Bupivicaine Infusion Using the On-Q Pain Pump After Laparoscopic Surgery (NCT NCT00533845)

Results Overview

Pain assessment using a subjective pain visual analog scale VAS with cough at 48 hours. Participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

48 hours postop

Results posted on

2019-04-16

Participant Flow

1 participant randomized to bupivicaine did not complete the study because the participant had to be returned to surgery prior to commencement of study procedures

Participant milestones

Participant milestones
Measure	Bupivacaine On-Q pump containing Bupivacaine implanted On-Q Pain Pump: Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally	Placebo/Control Saline used in the implanted On-Q device
Overall Study STARTED	15	15
Overall Study COMPLETED	14	15
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Bupivacaine On-Q pump containing Bupivacaine implanted On-Q Pain Pump: Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally	Placebo/Control Saline used in the implanted On-Q device
Overall Study Physician Decision	1	0

Baseline Characteristics

Intraperitoneal Bupivicaine Infusion Using the On-Q Pain Pump After Laparoscopic Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bupivacaine n=15 Participants On-Q pump containing Bupivacaine implanted On-Q Pain Pump: Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally	Placebo/Control n=15 Participants Saline used in the implanted On-Q device	Total n=30 Participants Total of all reporting groups
Age, Continuous	45.6 years STANDARD_DEVIATION 9.7 • n=5 Participants	42.0 years STANDARD_DEVIATION 11.8 • n=7 Participants	43.8 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Pain Scale	3.5 units on a scale STANDARD_DEVIATION .75 • n=5 Participants	3.5 units on a scale STANDARD_DEVIATION .75 • n=7 Participants	3.5 units on a scale STANDARD_DEVIATION .75 • n=5 Participants

PRIMARY outcome

Timeframe: 48 hours postop

Pain assessment using a subjective pain visual analog scale VAS with cough at 48 hours. Participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).

Outcome measures

Outcome measures
Measure	Bupivacaine n=14 Participants On-Q pump containing Bupivacaine implanted On-Q Pain Pump: Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally	Placebo/Control n=15 Participants Saline used in the implanted On-Q device
Visual Aanalog Scale (VAS) for Pain Assessment With Cough at 48 Hours	1.7 units on a scale Standard Deviation 1.94	3.9 units on a scale Standard Deviation 2.88

Adverse Events

Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo/Control

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

Danny A Sherwinter

Maimonides Medical center

Phone: 7182837952

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place