Does Bupivacaine in Laparoscopic Portals Reduce Post Surgery Pain in Tubal Ligation by Electrocoagulation?
NCT ID: NCT00810563
Last Updated: 2009-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
46 participants
INTERVENTIONAL
2008-08-31
2009-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Saline solution 0.9% 5mL in each portal
Saline solution (laparoscopic tubal ligation)
5ml of saline solution in each portal of the trocar (2 portals)
2
Bupivacaine 0.5% 5mL in each portal
Bupivacaine
5ml of bupivacaine 0.5% in each trocar portal
Interventions
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Saline solution (laparoscopic tubal ligation)
5ml of saline solution in each portal of the trocar (2 portals)
Bupivacaine
5ml of bupivacaine 0.5% in each trocar portal
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Use of analgesic within 12 hours prior the surgery
* Known allergy or contraindications to bupivacaine, dipyrone, porphine, or sodium diclofenac
25 Years
50 Years
FEMALE
Yes
Sponsors
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Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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HCPA - UFRGS
Principal Investigators
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Ricardo F Savaris, MD
Role: PRINCIPAL_INVESTIGATOR
HCPA/UFRGS
Locations
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Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Facility Contacts
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Ricardo F Savaris, MD
Role: primary
References
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Rioux JE, Daris M. Female sterilization: an update. Curr Opin Obstet Gynecol. 2001 Aug;13(4):377-81. doi: 10.1097/00001703-200108000-00002.
Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available.
Colbert ST, Moran K, O'Hanlon DM, Chambers F, Moriarty DC, Blunnie WP. An assessment of the value of intraperitoneal meperidine for analgesia postlaparoscopic tubal ligation. Anesth Analg. 2000 Sep;91(3):667-70. doi: 10.1097/00000539-200009000-00032.
Curry CS, Darby JR, Janssen BR. Evaluation of pain following electrocautery tubal ligation and effect of intraoperative fentanyl. J Clin Anesth. 1996 May;8(3):216-9. doi: 10.1016/0952-8180(95)00233-2.
Chi IC, Cole LP. Incidence of pain among women undergoing laparoscopic sterilization by electrocoagulation, the spring-loaded clip, and the tubal ring. Am J Obstet Gynecol. 1979 Oct 1;135(3):397-401. doi: 10.1016/0002-9378(79)90713-0.
Savaris RF, Chicar LL, Cristovam RS, Moraes GS, Miguel OA. Does bupivacaine in laparoscopic ports reduce postsurgery pain in tubal ligation by electrocoagulation? A randomized controlled trial. Contraception. 2010 Jun;81(6):542-6. doi: 10.1016/j.contraception.2009.12.019. Epub 2010 Feb 10.
Other Identifiers
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GPPG 08-293
Identifier Type: -
Identifier Source: secondary_id
DOPOL 08-294
Identifier Type: -
Identifier Source: org_study_id