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

H

Hospital de Clinicas de Porto Alegre

Status

Unknown

Conditions

Pain

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00810563
GPPG 08-293
DOPOL 08-294

Details and patient eligibility

About

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

Full 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

Enrollment

46 estimated patients

Sex

Female

Ages

25 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

46 participants in 2 patient groups, including a placebo group

1
Placebo Comparator group
Description:
Saline solution 0.9% 5mL in each portal
Treatment:
Drug: Saline solution (laparoscopic tubal ligation)
2
Active Comparator group
Description:
Bupivacaine 0.5% 5mL in each portal
Treatment:
Drug: Bupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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