Does Bupivacaine in Laparoscopic Portals Reduce Post Surgery Pain in Tubal Ligation by Electrocoagulation?

Study Overview
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Brief Summary
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The use of bupivacaine , an anesthesic, in laparoscopic portals is recommended in some surgeries. In the ase of tubal ligation by electrocoagulation, where pain is reduced, there is no evidence of this benefit. The objective of this study is to verify the degree of pain after laparoscopic tubal ligation surgery in patient who received bupivacaine 0.5% in the portal, or placebo

Detailed Description
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In order to conduct this study, the internal and external validation were considered. The author will use different gynecological teams, with different expertise to perform the laparoscopic tubal ligation, but using the same surgical and anesthesic technique. Second year residents, during their rotation, and medical staff will perform the surgery. Anesthesic technique: Intravenous remifentanil 0.1-0.5 micrograms/kg/min Intravenous Propofol target controlled or sevoflurane Intermittent ventilation using O2 40 - 100%, with or without compressed air. Before incision: 5mL of bupivacaine 0.5% or saline solution 0.9% from the aponeurosis until the skin In the end of the procedure: intravenous 4mg of dexamethasone + 40mg of tenoxican Post-operation prescription: NPO util well awake, then free according to patient´s tolerance If nausea/vomit: metoclopramide 10mg IV If pain: dipyrone 1g IV qid If pain is intense: morphine 3mg IV 3/3 h If pain persists: morphine 1mg h/h After hospital discharge: If pain: sodium diclofenac 50mg tid

Official Title
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Assessment of Postoperatory Pain After Laparoscopic Tubal Ligation by Electrocoagulation With Bupivacaine or Placebo

Conditions
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Pain

Intervention / Treatment
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* Drug: Saline solution (laparoscopic tubal ligation)
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients schedule for laparoscopic tubal ligation Exclusion Criteria: Not willing to consent Use of analgesic within 12 hours prior the surgery Known allergy or contraindications to bupivacaine, dipyrone, porphine, or sodium diclofenac

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 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: 1<br>Saline solution 0.9% 5mL in each portal | Drug: Saline solution (laparoscopic tubal ligation)<br>* 5ml of saline solution in each portal of the trocar (2 portals)<br>|
| Active Comparator: 2<br>Bupivacaine 0.5% 5mL in each portal | Drug: Bupivacaine<br>* 5ml of bupivacaine 0.5% in each trocar portal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | at 15, 30 and 120 minutes and 14 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of medication for pain |  | at 15, 30 and 120 minutes after surgery and 14 hours later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, tubal ligation, bupivacaine, laparoscopy