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

Condition(s) targeted: Pain

Intervention: Saline solution (laparoscopic tubal ligation) (Drug); Bupivacaine (Drug)

Phase: N/A

Status: Recruiting

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

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

Minimum age: 25 Years. Maximum age: 50 Years. Gender(s): Female.

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

Hospital de Clínicas de Porto Alegre, Porto Alegre, RS 90035-903, Brazil; Recruiting
Ricardo F Savaris, MD, Email: rsavaris@hcpa.ufrgs.br

Related publications:

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.

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