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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00810563
First received: December 17, 2008
Last updated: August 27, 2009
Last verified: August 2009
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Postoperatory Pain After Laparoscopic Tubal Ligation by Electrocoagulation With Bupivacaine or Placebo

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Pain [ Time Frame: at 15, 30 and 120 minutes and 14 hours after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Use of medication for pain [ Time Frame: at 15, 30 and 120 minutes after surgery and 14 hours later ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: August 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810563

Locations
Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035-903
Contact: Ricardo F Savaris, MD       rsavaris@hcpa.ufrgs.br   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Ricardo F Savaris, MD HCPA/UFRGS
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ricardo Francalacci Savaris, HCPA - UFRGS
ClinicalTrials.gov Identifier: NCT00810563     History of Changes
Other Study ID Numbers: DOPOL 08-294, GPPG 08-293
Study First Received: December 17, 2008
Last Updated: August 27, 2009
Health Authority: Brazil: Ministry of Health

Keywords provided by Hospital de Clinicas de Porto Alegre:
pain
tubal ligation
bupivacaine
laparoscopy

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014