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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00810563
Recruitment Status : Unknown
Verified August 2009 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : December 18, 2008
Last Update Posted : August 28, 2009
Information provided by:
Hospital de Clinicas de Porto Alegre

Brief 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

Condition or disease Intervention/treatment Phase
Pain Drug: Saline solution (laparoscopic tubal ligation) Drug: Bupivacaine Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Postoperatory Pain After Laparoscopic Tubal Ligation by Electrocoagulation With Bupivacaine or Placebo
Study Start Date : August 2008
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: 1
Saline solution 0.9% 5mL in each portal
Drug: Saline solution (laparoscopic tubal ligation)
5ml of saline solution in each portal of the trocar (2 portals)

Active Comparator: 2
Bupivacaine 0.5% 5mL in each portal
Drug: Bupivacaine
5ml of bupivacaine 0.5% in each trocar portal

Primary Outcome Measures :
  1. Pain [ Time Frame: at 15, 30 and 120 minutes and 14 hours after surgery ]

Secondary Outcome Measures :
  1. Use of medication for pain [ Time Frame: at 15, 30 and 120 minutes after surgery and 14 hours later ]

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00810563

Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035-903
Contact: Ricardo F Savaris, MD   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Principal Investigator: Ricardo F Savaris, MD HCPA/UFRGS

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ricardo Francalacci Savaris, HCPA - UFRGS Identifier: NCT00810563     History of Changes
Other Study ID Numbers: DOPOL 08-294
GPPG 08-293
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: August 28, 2009
Last Verified: August 2009

Keywords provided by Hospital de Clinicas de Porto Alegre:
tubal ligation

Additional relevant MeSH terms:
Pharmaceutical Solutions
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents