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

Pain Clinical Trial

— DOPOL  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00810563
• Other study ID #: DOPOL 08-294
• Secondary ID: GPPG 08-293
• Status: Unknown status
• Phase: N/A
• First received: December 17, 2008
• Last updated: August 27, 2009
• Start date: August 2008
• Est. completion date: August 2009

Study information

• Verified date: August 2009
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 46
• Est. completion date: August 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rioux JE, Daris M. Female sterilization: an update. Curr Opin Obstet Gynecol. 2001 Aug;13(4):377-81. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain		at 15, 30 and 120 minutes and 14 hours after surgery
Secondary	Use of medication for pain		at 15, 30 and 120 minutes after surgery and 14 hours later