Does Bupivacaine in Laparoscopic Portals Reduce Post Surgery Pain in Tubal Ligation by Electrocoagulation?
Information source: Hospital de Clinicas de Porto Alegre
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Saline solution (laparoscopic tubal ligation) (Drug); Bupivacaine (Drug)
Sponsored by: Hospital de Clinicas de Porto Alegre
Official(s) and/or principal investigator(s):
Ricardo F Savaris, MD, Principal Investigator, Affiliation: HCPA/UFRGS
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
Official title: Assessment of Postoperatory Pain After Laparoscopic Tubal Ligation by Electrocoagulation With Bupivacaine or Placebo
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pain
Secondary outcome: Use of medication for pain
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.
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
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
Minimum age: 25 Years.
Maximum age: 50 Years.
- All patients schedule for laparoscopic tubal ligation
- Not willing to consent
- Use of analgesic within 12 hours prior the surgery
- Known allergy or contraindications to bupivacaine, dipyrone, porphine, or sodium
Locations and Contacts
Hospital de Clínicas de Porto Alegre, Porto Alegre, RS 90035-903, Brazil; Recruiting
Ricardo F Savaris, MD, Email: firstname.lastname@example.org
Rioux JE, Daris M. Female sterilization: an update. Curr Opin Obstet Gynecol. 2001 Aug;13(4):377-81. Review.
Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. Review. 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.
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.
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.
Starting date: August 2008
Last updated: August 27, 2009