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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
On-Q Pain Pump
Sponsored by
Maimonides Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing laparoscopic cholecystectomy or Lap-Band ASA III or less

Exclusion Criteria:

  • Patients who refuse consent
  • Are converted from laparoscopy to open surgery
  • Are allergic to bupivacaine
  • Are unable to followup

Sites / Locations

  • Maimonides Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

On-Q pain pump

Placebo/control

Arm Description

Bupivacaine

Saline

Outcomes

Primary Outcome Measures

Visual Aanalog Scale (VAS) for Pain Assessment With Cough at 48 Hours
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).

Secondary Outcome Measures

Full Information

First Posted
September 20, 2007
Last Updated
April 14, 2019
Sponsor
Maimonides Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00533845
Brief Title
Intraperitoneal Bupivicaine Infusion Using the On-Q Pain Pump After Laparoscopic Surgery
Official Title
Intraperitoneal Bupivicaine Infusion Using the On-Q Pain Pump After Laparoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maimonides Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
After Laparoscopic surgery most patients experience some form of mild to moderate pain. The current standard of care is to treat this pain with local anesthetics (numbing medication, that deadens the nerve endings) to the small surgical incisions (cuts) and narcotic systemic analgesics (medication injected into your vein to control pain such as morphine). Although this treatment improves pain symptoms it is not perfect. Firstly, complete pain control is rarely achieved and secondly, narcotics (such as morphine) often have many side effects including nausea, vomiting, sedation (sleepiness), constipation and abdominal upset. All of these issues make recovery less comfortable and delays return to full function (work, school and other activities of daily life). A new FDA approved device is now available that offers the benefits of long term anesthesia without the side effects of narcotics. It consists of a pump that continuously infuses local anesthesia into and around the surgical site. This pump is placed during your operation. You then carry a tennis ball sized container made of soft plastic in a pouch which drips numbing medicine around your wounds for 2 days continuously. The purpose of this study is to see if this pump improves postoperative pain, decreases the need for narcotic pain medicine and allows people to return to their activities earlier.
Detailed Description
The procedure of the current study is to randomly assign patients undergoing minimally invasive surgeries (laparoscopic cholecystectomies and laparoscopic Lap-Banding procedures) to one of two groups. Both groups will have the standard surgical procedure performed and then at the completion will have the on-Q system placed in a subdiaphragmatic (within the abdomen) location. Half of the study group will have bupivicaine, a numbing medicine in the pump while the other half will have sterile saline in their pump. Neither the patient nor the surgeon will be aware of which group any particular patient is in, this is a process known as "blinding" and improves the reliability of the results. All patients will receive the standard locally infiltrated trocar site local anesthetic and either a prescription for Vicodin for ambulatory patients or morphine injected into their vein for patients staying in the hospital. All patients will then be asked at preset intervals their level of pain the presence of nausea and their need for Vicodin or morphine. Ambulatory patients will be reached by phone for answers to these questions. All patients will have their pain controlled in the usual and standard way at all times. The On-Q pump will be removed at 48hours. The results will then be statistically reviewed to see if the On-Q pumps were of benefit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
On-Q pain pump
Arm Type
Experimental
Arm Description
Bupivacaine
Arm Title
Placebo/control
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Drug
Intervention Name(s)
On-Q Pain Pump
Other Intervention Name(s)
Marcaine
Intervention Description
Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally
Primary Outcome Measure Information:
Title
Visual Aanalog Scale (VAS) for Pain Assessment With Cough at 48 Hours
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing laparoscopic cholecystectomy or Lap-Band ASA III or less Exclusion Criteria: Patients who refuse consent Are converted from laparoscopy to open surgery Are allergic to bupivacaine Are unable to followup
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danny A Sherwinter, MD
Organizational Affiliation
Maimonides Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States

12. IPD Sharing Statement

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

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