Clinical Proposal for the Comparison of Intraperitoneal Anesthetic to Injected Local Anesthetic
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| ClinicalTrials.gov Identifier: NCT00508976 |
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Recruitment Status :
Completed
First Posted : July 30, 2007
Last Update Posted : May 10, 2012
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Sponsor:
Pinnacle Health System
Information provided by (Responsible Party):
Troy Moritz, D.O., Pinnacle Health System
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain, Postoperative Morbid Obesity | Drug: Injected bupivacaine post-operatively Drug: Streamed bupivacaine versus streamed normal saline Drug: Aerosolized bupivacaine versus aerosolized saline Drug: Injected lidocaine pre-incision vs saline pre-incision | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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 Start Date : | June 2007 |
| Actual Primary Completion Date : | April 2008 |
| Actual Study Completion Date : | April 2008 |
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| Arm | Intervention/treatment |
|---|---|
| Experimental: 3 |
Drug: Streamed bupivacaine versus streamed normal saline
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.
Other Names:
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| Experimental: 2 |
Drug: Injected lidocaine pre-incision vs saline pre-incision
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.
Other Names:
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| Experimental: 4 |
Drug: Aerosolized bupivacaine versus aerosolized saline
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.
Other Names:
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| Active Comparator: 1 |
Drug: Injected bupivacaine post-operatively
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.
Other Name: bupivacaine |
Primary Outcome Measures :
- Measure of reduction in post-operative pain and narcotics usage. [ Time Frame: First 3 days post-operatively. ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508976
Locations
| United States, Pennsylvania | |
| Pinnacle Health; Community General Osteopathic Hospital | |
| Harrisburg, Pennsylvania, United States, 17109 | |
Sponsors and Collaborators
Pinnacle Health System
Investigators
| Principal Investigator: | Troy A Moritz, DO | Pinnacle Health; Community General Osteopathic Hospital |
Publications:
| Responsible Party: | Troy Moritz, D.O., Troy Moritz DO, Pinnacle Health System |
| ClinicalTrials.gov Identifier: | NCT00508976 |
| Other Study ID Numbers: |
PHH#07-005 |
| First Posted: | July 30, 2007 Key Record Dates |
| Last Update Posted: | May 10, 2012 |
| Last Verified: | May 2012 |
Keywords provided by Troy Moritz, D.O., Pinnacle Health System:
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bupivacaine marcaine lidocaine normal saline narcotics |
analog pain scale postoperative pain preemptive aerosolization streamed |
Additional relevant MeSH terms:
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Obesity, Morbid Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Obesity Overnutrition Nutrition Disorders Overweight Body Weight Lidocaine |
Bupivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |