Trial | NCT00810563  Report issue

Title

Does Bupivacaine in Laparoscopic Portals Reduce Post Surgery Pain in Tubal Ligation by Electrocoagulation?
Assessment of Postoperatory Pain After Laparoscopic Tubal Ligation by Electrocoagulation With Bupivacaine or Placebo

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Indication/Condition

    Pain

  • Study Participants

    46
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
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
Study Started
Aug 31
2008
Primary Completion
Mar 31
2009
Anticipated
Study Completion
Aug 31
2009
Anticipated
Last Update
Aug 28
2009
Estimate

Drug Saline solution (laparoscopic tubal ligation)

5ml of saline solution in each portal of the trocar (2 portals)

Drug Bupivacaine

5ml of bupivacaine 0.5% in each trocar portal

1 Placebo Comparator

Saline solution 0.9% 5mL in each portal

2 Active Comparator

Bupivacaine 0.5% 5mL in each portal

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
No Results Posted