NCT00914498

Brief Summary

This study will examine whether pre-incision infiltration of the skin cut site can attenuate post operative pain after a cesarean section. One hundred and twenty women will be allocated to get 20 ml of either placebo or 1% xylocaine at the site of skin incision. We will also examine possible effect of this infiltration of parameters of wound heeling and scar formation, six weeks post partum.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2009

Completed
26 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

August 25, 2009

Status Verified

August 1, 2009

Enrollment Period

1.4 years

First QC Date

June 4, 2009

Last Update Submit

August 23, 2009

Conditions

Pain Relief

Keywords

XylocaineCasarean sectionPost operative painScar quality

Outcome Measures

Primary Outcomes (1)

  • Level of post operative pain on a visual analog scale

    Up to 48 hours postoperative

Secondary Outcomes (1)

  • Appearance of operative scar, compared to previous scar

    6-8 weeks

Study Arms (2)

Xylocaine

EXPERIMENTAL

Participants will receive local injection of 20 ml 1% Xylocaine to the skin incision site

Drug: Local, pre-incisional injection of 20 ml 1% xylocaine

Controls

PLACEBO COMPARATOR

Participants will receive injection of 0.9% NaCl 20 ml to the incision site

Drug: Local, pre-incisional injection of 20 ml 1% xylocaine

Interventions

Local, pre-incisional injection of 20 ml 1% xylocaineDRUG

Local, pre-incisional injection of 20 ml 1% xylocaine

ControlsXylocaine

Eligibility Criteria

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

You may qualify if:

  • Candidates for non-emergency cesarean section

You may not qualify if:

  • Emergency cesarean section
  • Known or suspected sensitivity to local anesthetics
  • Pre-eclamptic toxemia
  • Deranged liver function
  • Deranged hemostasis
  • Lack of adequate verbal communication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics & Gynecology, Baruch Padeh Medical Center

Poria – Neve Oved, Israel

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Izhar Ben-Shlomo, MD

    Department of Obstetrics & Gynecology, Baruch Padeh Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Izhar Ben-Shlomo, MD

CONTACT

972-50-6268024izharbs@netvision.net.il

Aviva Peleg, MSc

CONTACT

972-50-6267521apeleg@poria.health.gov.il

Study Design

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

Study Record Dates

First Submitted

June 4, 2009

First Posted

June 5, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2010

Last Updated

August 25, 2009

Record last verified: 2009-08

Locations

IL(1)