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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00810563
Acronym
DOPOL
Enrollment
46
Registered
2008-12-18
Start date
2008-08-31
Completion date
2009-08-31
Last updated
2009-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

pain, tubal ligation, bupivacaine, laparoscopy

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

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

Interventions

DRUGSaline solution (laparoscopic tubal ligation)

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

DRUGBupivacaine

5ml of bupivacaine 0.5% in each trocar portal

Sponsors

Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frame
Painat 15, 30 and 120 minutes and 14 hours after surgery

Secondary

MeasureTime frame
Use of medication for painat 15, 30 and 120 minutes after surgery and 14 hours later

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026