NCT00737542

Brief Summary

The objective of this prospective, double-blinded, placebo-controlled, randomized study is to evaluate the impact of preemptive analgesia using incisional site infiltration of lidocaine as compared to saline solution on post operative pain control in women undergoing cesarean deliveries.

Trial Health

55
Monitor

Trial Health Score

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

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

First Submitted

Initial submission to the registry

August 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2008

Completed
Last Updated

November 26, 2009

Status Verified

August 1, 2008

First QC Date

August 17, 2008

Last Update Submit

November 25, 2009

Conditions

PainCesarean Delivery

Keywords

managementpost

Study Arms (2)

A

PLACEBO COMPARATOR
Drug: NACL 0.9%

B

EXPERIMENTAL
Drug: lidocaine

Interventions

lidocaineDRUG
B
NACL 0.9%DRUG
A

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women who are scheduled for an elective cesarean delivery under general/spinal analgesia using a transverse lower abdominal incision.

You may not qualify if:

  • More than two previous cesarean deliveries
  • Other abdominal operations in the past
  • Morbid obesity
  • Diabetes mellitus, neurological diseases, systemic vascular disease.
  • Mental disability
  • Lidocaine sensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Obstetrics and Gynecology - Soroka University Medical Center

Beersheba, Box 151, Israel

Location

MeSH Terms

Conditions

Pain

Interventions

LidocaineSodium Chloride

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2008

First Posted

August 19, 2008

Last Updated

November 26, 2009

Record last verified: 2008-08

Locations

IL(1)