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Clinical Proposal for the Comparison of Intraperitoneal Anesthetic to Injected Local Anesthetic

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Troy Moritz, D.O., Pinnacle Health System
ClinicalTrials.gov Identifier:
NCT00508976
First received: July 26, 2007
Last updated: May 9, 2012
Last verified: May 2012
History of Changes
  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
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Pinnacle Health System:

Primary Outcome Measures:
  • Measure of reduction in post-operative pain and narcotics usage. [ Time Frame: First 3 days post-operatively. ] [ Designated as safety issue: No ]

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
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:
  • bupivacaine
  • marcaine
  • normal saline
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:
  • lidocaine
  • normal saline
  • pre-emptive
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:
  • bupivacaine
  • marcaine
  • normal saline
  • aerosolized
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Troy Moritz, D.O., Troy Moritz DO, Pinnacle Health System
ClinicalTrials.gov Identifier: NCT00508976     History of Changes
Other Study ID Numbers: PHH#07-005
Study First Received: July 26, 2007
Last Updated: May 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pinnacle Health System:
bupivacaine
marcaine
lidocaine
normal saline
narcotics
 analog pain scale
postoperative pain
preemptive
aerosolization
streamed

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Pain, Postoperative
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Anesthetics, Local
 Bupivacaine
Lidocaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013