Assessment of Postoperatory Pain After Laparoscopic Tubal Ligation by Electrocoagulation With Bupivacaine or Placebo
Overview
- Phase
- Not Applicable
- Intervention
- Saline solution (laparoscopic tubal ligation)
- Conditions
- Pain
- Sponsor
- Hospital de Clinicas de Porto Alegre
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Pain
- Last Updated
- 16 years ago
Overview
Brief Summary
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
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
Investigators
Eligibility Criteria
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
Arms & Interventions
1
Saline solution 0.9% 5mL in each portal
Intervention: Saline solution (laparoscopic tubal ligation)
2
Bupivacaine 0.5% 5mL in each portal
Intervention: Bupivacaine
Outcomes
Primary Outcomes
Pain
Time Frame: at 15, 30 and 120 minutes and 14 hours after surgery
Secondary Outcomes
- Use of medication for pain(at 15, 30 and 120 minutes after surgery and 14 hours later)