Back to resultsClinical Proposal for the Comparison of Intraperitoneal Anesthetic to Injected Local Anesthetic
Primary Purpose
Pain, Postoperative, Morbid Obesity
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Injected bupivacaine post-operatively
Streamed bupivacaine versus streamed normal saline
Aerosolized bupivacaine versus aerosolized saline
Injected lidocaine pre-incision vs saline pre-incision
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring bupivacaine, marcaine, lidocaine, normal saline, narcotics, analog pain scale, postoperative pain, preemptive, aerosolization, streamed
Eligibility Criteria
Inclusion Criteria:
- Male and female patients between 18 and 65 years of age.
- Patients undergoing elective bariatric surgery.
Exclusion Criteria:
- Patients allergic to bupivacaine or any other local anesthetics (amides & esters).
- Patients who have used opiates or opiods within 15 days prior to surgery.
- Patients converted to open gastric bypass.
Sites / Locations
- Pinnacle Health; Community General Osteopathic Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
3
2
4
1
Arm Description
Outcomes
Primary Outcome Measures
Measure of reduction in post-operative pain and narcotics usage.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00508976
Brief Title
Clinical Proposal for the Comparison of Intraperitoneal Anesthetic to Injected Local Anesthetic
Official Title
Evaluation of Aerosolized Bupivacaine Versus Pre-incision Lidocaine Versus Instilled Liquid Bupivacaine Versus Post-operative Bupivacaine Injection for Optimization of Post-operative Pain Control in Laparoscopic Bariatric Surgical Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pinnacle Health System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if pre-incisional lidocaine injection, instilled liquid bupivacaine, intra-abdominal aerosolized bupivacaine, or post-operative bupivacaine injection is superior in post-operative pain control in laparoscopic bariatric surgical patients.
Detailed Description
The research objective is to compare our standard post-operative port site injection of 0.5% bupivacaine against pre-incisional port site injection of 1% lidocaine against the instillation of streamed bupivacaine 0.5% against the instillation of aerosolized 0.5% bupivacaine as it relates to post-operative analgesia usage and pain scale scores. The null hypothesis will be that there is no difference between the four arms of the study in regards to pain score and analgesia usage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Morbid Obesity
Keywords
bupivacaine, marcaine, lidocaine, normal saline, narcotics, analog pain scale, postoperative pain, preemptive, aerosolization, streamed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Arm Title
1
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Injected bupivacaine post-operatively
Other Intervention Name(s)
bupivacaine
Intervention Description
Patients will receive 30 ml of 0.9% normal saline divided equally and injected prior to port site incision, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation, and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.
Intervention Type
Drug
Intervention Name(s)
Streamed bupivacaine versus streamed normal saline
Other Intervention Name(s)
bupivacaine, marcaine, normal saline
Intervention Description
Patients will receive 30ml of 0.9% normal saline divided equally and injected prior to port site incisions, then 10ml of 0.5% bupivacaine streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.
Intervention Type
Drug
Intervention Name(s)
Aerosolized bupivacaine versus aerosolized saline
Other Intervention Name(s)
bupivacaine, marcaine, normal saline, aerosolized
Intervention Description
Patients will receive 30 ml of 0.9% normal saline divided equally and injected prior to port site incision, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.5% bupivacaine aerosolized into coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.
Intervention Type
Drug
Intervention Name(s)
Injected lidocaine pre-incision vs saline pre-incision
Other Intervention Name(s)
lidocaine, normal saline, pre-emptive
Intervention Description
Patients will receive 30ml of 1% lidocaine divided equally and injected prior to port site incisions, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.
Primary Outcome Measure Information:
Title
Measure of reduction in post-operative pain and narcotics usage.
Time Frame
First 3 days post-operatively.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female patients between 18 and 65 years of age.
Patients undergoing elective bariatric surgery.
Exclusion Criteria:
Patients allergic to bupivacaine or any other local anesthetics (amides & esters).
Patients who have used opiates or opiods within 15 days prior to surgery.
Patients converted to open gastric bypass.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Troy A Moritz, DO
Organizational Affiliation
Pinnacle Health; Community General Osteopathic Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pinnacle Health; Community General Osteopathic Hospital
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17109
Country
United States
12. IPD Sharing Statement
Citations:
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Clinical Proposal for the Comparison of Intraperitoneal Anesthetic to Injected Local Anesthetic
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