Effects of Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair

Study Overview
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Brief Summary
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To assess effect of local anesthetic into the preperitoneal space during laparoscopic hernia repair on post-operative pain.

Official Title
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A Randomized, Double-blinded, Placebo-controlled Trial of the Effects of Infusing Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair

Conditions
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Post Operative Pain (Post Laparoscopic Hernia Repair)

Intervention / Treatment
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* Drug: 0.5% Bupivicaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older with unilateral or bilateral inguinal herna for laparoscopic repair American Society of Anesthesiology (ASA) Class I and II Exclusion Criteria: Conversion from laparoscopic to open surgery History of Chronic pain or ongoing treatment for chronic pain Age less than 18 yrs Allergy to local anesthetics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anesthetic intervention<br>After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the treatment group will receive infusion of 15 cc 0.5% Bupivicaine. | Drug: 0.5% Bupivicaine<br>* Local anesthetic<br>* Other names: Sensorcaine;|
| Placebo Comparator: Saline intervention<br>After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the placebo group will receive the infusion of 15 cc 0.9% Saline. | Drug: 0.5% Bupivicaine<br>* Local anesthetic<br>* Other names: Sensorcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale Pain Score Assessment (VAS) | Pain level at 4 hours after surgery VAS scale measures pain in whole numbers from 0 (no pain) to 10 (worst imaginable pain) | Post-operative period | 
| Visual Analog Scale Pain Score Assessment (VAS) | Pain level recorded at 3 days after surgery. VAS scale measures pain in increments of whole numbers from 0 (no pain) to 10 (most sever pain imaginable) | Pain scale 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Pain Medication Used in Oral Morphine Equivalents | Total mg of opiate after surgery | 4 hours after surgery | 
| Duration of Narcotic Used to Control Pain | Number of days post-operatively narcotic is used | 4 weeks post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post Operative Pain, hernia repair