NCT00965796

Brief Summary

The objective of the present study was to evaluate the effect of intraoperative intravenous lidocaine on postoperative pain after hysterectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

May 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
Last Updated

August 26, 2009

Status Verified

August 1, 2009

Enrollment Period

5 months

First QC Date

August 24, 2009

Last Update Submit

August 25, 2009

Conditions

Pain Intensity

Keywords

Intravenous lidocainepostoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • Pain

    24hours

Study Arms (1)

Lidocaine, pain intensity and Saline

EXPERIMENTAL

(2 mg/kg/h) and patients of group 2 (n = 20) received 0.9% saline infusion throughout the surgical procedure

Drug: Lidocaine

Interventions

LidocaineDRUG

Lidocaine 2 mg/kg/h- during surgical procedure Saline

Also known as: Intravenous lidocaine
Lidocaine, pain intensity and Saline

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA 1 or 2, aged 18 to 60 years undergoing hysterectomy

You may not qualify if:

  • Cardiac arrhythmia; myocardiopathy
  • Altered cardiac conduction
  • Psychiatric, hepatic or respiratory disease
  • Patients receiving any type of analgesic during the week before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rioko K Sakata- Universidade Federal de São Paulo

São Paulo, Rua Botucatu-593, 04023-062, Brazil

Location

Universidade Federal de São Paulo

São Paulo, São Paulo, 04023-062, Brazil

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Rioko K Sakata, PhD

    Universidade Federal de São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 26, 2009

Study Start

May 1, 2008

Primary Completion

October 1, 2008

Study Completion

December 1, 2008

Last Updated

August 26, 2009

Record last verified: 2009-08

Locations

BR(2)