NCT00810563

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 28, 2009

Status Verified

August 1, 2009

Enrollment Period

7 months

First QC Date

December 17, 2008

Last Update Submit

August 27, 2009

Conditions

Pain

Keywords

paintubal ligationbupivacainelaparoscopy

Outcome Measures

Primary Outcomes (1)

  • Pain

    at 15, 30 and 120 minutes and 14 hours after surgery

Secondary Outcomes (1)

  • Use of medication for pain

    at 15, 30 and 120 minutes after surgery and 14 hours later

Study Arms (2)

1

PLACEBO COMPARATOR

Saline solution 0.9% 5mL in each portal

Drug: Saline solution (laparoscopic tubal ligation)

2

ACTIVE COMPARATOR

Bupivacaine 0.5% 5mL in each portal

Drug: Bupivacaine

Interventions

Saline solution (laparoscopic tubal ligation)DRUG

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

1
BupivacaineDRUG

5ml of bupivacaine 0.5% in each trocar portal

2

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All patients schedule for laparoscopic tubal ligation

You may not qualify if:

  • Not willing to consent
  • Use of analgesic within 12 hours prior the surgery
  • Known allergy or contraindications to bupivacaine, dipyrone, porphine, or sodium diclofenac

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

Related Publications (6)

  • Rioux JE, Daris M. Female sterilization: an update. Curr Opin Obstet Gynecol. 2001 Aug;13(4):377-81. doi: 10.1097/00001703-200108000-00002.

    PMID: 11452199BACKGROUND

  • Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available.

    PMID: 9389858BACKGROUND

  • Colbert ST, Moran K, O'Hanlon DM, Chambers F, Moriarty DC, Blunnie WP. An assessment of the value of intraperitoneal meperidine for analgesia postlaparoscopic tubal ligation. Anesth Analg. 2000 Sep;91(3):667-70. doi: 10.1097/00000539-200009000-00032.

    PMID: 10960397BACKGROUND

  • Curry CS, Darby JR, Janssen BR. Evaluation of pain following electrocautery tubal ligation and effect of intraoperative fentanyl. J Clin Anesth. 1996 May;8(3):216-9. doi: 10.1016/0952-8180(95)00233-2.

    PMID: 8703457BACKGROUND

  • Chi IC, Cole LP. Incidence of pain among women undergoing laparoscopic sterilization by electrocoagulation, the spring-loaded clip, and the tubal ring. Am J Obstet Gynecol. 1979 Oct 1;135(3):397-401. doi: 10.1016/0002-9378(79)90713-0.

    PMID: 158312BACKGROUND

  • Savaris RF, Chicar LL, Cristovam RS, Moraes GS, Miguel OA. Does bupivacaine in laparoscopic ports reduce postsurgery pain in tubal ligation by electrocoagulation? A randomized controlled trial. Contraception. 2010 Jun;81(6):542-6. doi: 10.1016/j.contraception.2009.12.019. Epub 2010 Feb 10.

    PMID: 20472124DERIVED

MeSH Terms

Conditions

Pain

Interventions

Saline SolutionBupivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Ricardo F Savaris, MD

    HCPA/UFRGS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 17, 2008

First Posted

December 18, 2008

Study Start

August 1, 2008

Primary Completion

March 1, 2009

Study Completion

August 1, 2009

Last Updated

August 28, 2009

Record last verified: 2009-08

Locations

BR(1)