Clinical trial NCT00508976: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain, Postoperative
Morbid Obesity
Keywords: bupivacaine
marcaine
lidocaine
normal saline
narcotics
analog pain scale
postoperative pain
preemptive
aerosolization
streamed
Lead sponsor: Pinnacle Health System
Sponsor class: OTHER
First posted: 2007-07-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Male and female patients between 18 and 65 years of age.
2. Patients undergoing elective bariatric surgery.

Exclusion Criteria:

1. Patients allergic to bupivacaine or any other local anesthetics (amides \& esters).
2. Patients who have used opiates or opiods within 15 days prior to surgery.
3. Patients converted to open gastric bypass.

Primary outcomes:
measure: Measure of reduction in post-operative pain and narcotics usage.
timeFrame: First 3 days post-operatively.
Secondary outcomes:
Other outcomes:
Locations:
city: Harrisburg
country: United States
facility: Pinnacle Health; Community General Osteopathic Hospital
state: Pennsylvania
Study officials:
affiliation: Pinnacle Health; Community General Osteopathic Hospital
name: Troy A Moritz, DO
role: PRINCIPAL_INVESTIGATOR
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