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

Pinnacle Health System

Status and phase: Completed; Phase 2

Conditions: Pain, Postoperative; Morbid Obesity

Treatments: Drug: Injected bupivacaine post-operatively; Drug: Aerosolized bupivacaine versus aerosolized saline; Drug: Streamed bupivacaine versus streamed normal saline; Drug: Injected lidocaine pre-incision vs saline pre-incision

Study type: Interventional

Funder types: Other

Identifiers

NCT00508976

PHH#07-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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100 participants in 4 patient groups

3

Experimental group

Treatment:

Drug: Streamed bupivacaine versus streamed normal saline

2

Experimental group

Treatment:

Drug: Injected lidocaine pre-incision vs saline pre-incision

4

Experimental group

Treatment:

Drug: Aerosolized bupivacaine versus aerosolized saline

1

Active Comparator group

Treatment:

Drug: Injected bupivacaine post-operatively