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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00533845
Recruitment Status : Completed
First Posted : September 24, 2007
Results First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Danny A Sherwinter, Maimonides Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Postoperative Pain
Intervention Drug: On-Q Pain Pump
Enrollment 30
Recruitment Details 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
Pre-assignment Details  
Arm/Group Title Bupivacaine Placebo/Control
Hide Arm/Group Description

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

Saline used in the implanted On-Q device
Period Title: Overall Study
Started 15 15
Completed 14 15
Not Completed 1 0
Reason Not Completed
Physician Decision             1             0
Arm/Group Title Bupivacaine Placebo/Control Total
Hide Arm/Group Description

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

Saline used in the implanted On-Q device Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
Baseline analysis - 30 enrolled but only 29 evaluated because patient required re-operative intervention with removal of experimental device precluding assessment of VAS pain scores
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
45.6  (9.7) 42.0  (11.8) 43.8  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
11
  73.3%
11
  73.3%
22
  73.3%
Male
4
  26.7%
4
  26.7%
8
  26.7%
Pain Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 15 participants 30 participants
3.5  (.75) 3.5  (.75) 3.5  (.75)
[1]
Measure Description: Likert scale ranging from 0 to 10 (0 being no pain and 10 being very severe pain)
1.Primary Outcome
Title Visual Aanalog Scale (VAS) for Pain Assessment With Cough at 48 Hours
Hide Description 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).
Time Frame 48 hours postop
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine Placebo/Control
Hide Arm/Group Description:

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

Saline used in the implanted On-Q device
Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.7  (1.94) 3.9  (2.88)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupivacaine, Placebo/Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0022
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bupivacaine Placebo/Control
Hide Arm/Group Description

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

Saline used in the implanted On-Q device
All-Cause Mortality
Bupivacaine Placebo/Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Bupivacaine Placebo/Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bupivacaine Placebo/Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Danny A Sherwinter
Organization: Maimonides Medical center
Phone: 7182837952
EMail: dsherwinter@maimonidesmed.org
Layout table for additonal information
Responsible Party: Danny A Sherwinter, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT00533845    
Other Study ID Numbers: 07/02/VA13
First Submitted: September 20, 2007
First Posted: September 24, 2007
Results First Submitted: August 11, 2015
Results First Posted: April 16, 2019
Last Update Posted: April 16, 2019