Study to Compare Reduction in Pain After Surgery With and Without Local Anesthesia During Laparoscopy

Study Overview
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Brief Summary
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This study will help to answer the question, Does injecting local anesthetic before laparoscopic instrument ports are placed decrease pain after surgery? Patients participating will be randomly assigned to receive local anesthetic or saline injection at the site of a laparoscopic instrument port as part of their planned surgery. After surgery at 4 and 24 hours the patient will be asked to rate their pain on a simple chart.

Detailed Description
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The literature is divided on the efficacy of preincisional local analgesia injections at laparoscopic port sites to decrease post operative pain. One reason for this lack of a clear conclusion is the fact that prior studies included small and large port sizes. Many small port sites have little pain associated with them so showing a reduction with medicine is statistically difficult. The investigators have noted that larger, lateral port sites which require fascial closure are the sites that patients consistently note pain at. Our protocol will include the use of 0.25% marcaine injections at all the surgical ports other than the large lateral port used for gynecologic laparoscopy. Patients would then be randomized and surgeons would be blinded as to which patients receive the marcaine or a saline injection at the large lateral port site. Visual analog pain scales will be assessed at 4 and 24 hours after surgery. An additional two arms have been added to include 50 patients randomized to 0.25% marcaine or saline injection just prior to incisional closure in the absence of any preincisional intervention.

Official Title
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Effect of Preincisional Local Analgesia on Post-Operative Pain in 10-12mm Lateral Port Sites

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: 0.25% bupivicaine will be injected at the study port site prior to incision
* Drug: Saline will be injected at the study port site prior to incision
* Drug: Saline will be in injected into the port site prior to closure
* Drug: 0.25% bupivicaine will be injected into the port site prior to closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing laparoscopic surgery Exclusion Criteria: Cardiovascular instability malignancies pulmonary conditions incompatible with laparoscopic surgery

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

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 |
| --- | --- |
| Placebo Comparator: Preincision Placebo<br>This group of patients will receive saline injection at study port site before incision | Drug: Saline will be injected at the study port site prior to incision<br>* Injection will precede incision<br>* Other names: normal saline;|
| Active Comparator: Preincision Marcaine<br>This group will receive marcaine injection at the study port site prior to incision | Drug: 0.25% bupivicaine will be injected at the study port site prior to incision<br>* Injection will precede the incision<br>* Other names: marcaine;|
| Placebo Comparator: Postincision Placebo<br>This group of patients will receive preincisional marcaine and then saline injection at study port site prior to closure | Drug: 0.25% bupivicaine will be injected at the study port site prior to incision<br>* Injection will precede the incision<br>* Other names: marcaine;Drug: Saline will be in injected into the port site prior to closure<br>* Saline will be injected into the port site prior to the closure without any preincisional intervention<br>|
| Active Comparator: Postincision marcaine<br>This group will receive preincisional marcaine and then marcaine injection at study port site prior to closure | Drug: 0.25% bupivicaine will be injected at the study port site prior to incision<br>* Injection will precede the incision<br>* Other names: marcaine;Drug: 0.25% bupivicaine will be injected into the port site prior to closure<br>* 0.25% bupivicaine will be injected into the port site at closure without any preincisional intervention<br>* Other names: marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in post-operative pain at large lateral port sites | visual analog scoring of post-operative pain in a control and a treatment group | 4 and 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, laparoscopy, reduction