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| Sponsored by: |
Pinnacle Health System |
|---|---|
| Information provided by: | Pinnacle Health System |
| ClinicalTrials.gov Identifier: | NCT00508976 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pain, Postoperative Pain Measurement Postoperative Care |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2007 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 3: Experimental |
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.
|
| 2: Experimental |
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.
|
| 4: Experimental |
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.
|
| 1: Active Comparator |
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| Pinnacle Health; Community General Osteopathic Hospital | |
| Harrisburg, Pennsylvania, United States, 17109 | |
| Principal Investigator: | Troy A Moritz, DO | Pinnacle Health; Community General Osteopathic Hospital |
More Information
| Study ID Numbers: | PHH#07-005 |
| Study First Received: | July 26, 2007 |
| Last Updated: | May 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00508976 |
| Health Authority: | United States: Institutional Review Board |
|
bupivacaine marcaine lidocaine normal saline narcotics |
analog pain scale postoperative pain preemptive aerosolization streamed |
|
Signs and Symptoms Postoperative Complications Lidocaine |
Bupivacaine Pain Pain, Postoperative |
|
Pathologic Processes Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Anesthetics |
Cardiovascular Agents Anti-Arrhythmia Agents Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions Anesthetics, Local |
