search
Back to results

The Effect of Pre-incisional Local Xylocaine Injection on Post Operative Pain and Scar Formation After Cesarean Section

Primary Purpose

Pain Relief

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Local, pre-incisional injection of 20 ml 1% xylocaine
Sponsored by
The Baruch Padeh Medical Center, Poriya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain Relief focused on measuring Xylocaine, Casarean section, Post operative pain, Scar quality

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Candidates for non-emergency cesarean section

Exclusion Criteria:

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

Sites / Locations

  • Department of Obstetrics & Gynecology, Baruch Padeh Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Xylocaine

Controls

Arm Description

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

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

Outcomes

Primary Outcome Measures

Level of post operative pain on a visual analog scale

Secondary Outcome Measures

Appearance of operative scar, compared to previous scar

Full Information

First Posted
June 4, 2009
Last Updated
August 23, 2009
Sponsor
The Baruch Padeh Medical Center, Poriya
search

1. Study Identification

Unique Protocol Identification Number
NCT00914498
Brief Title
The Effect of Pre-incisional Local Xylocaine Injection on Post Operative Pain and Scar Formation After Cesarean Section
Official Title
The Effect of Pre-incisional Local Xylocaine Injection on Post Operative Pain and Scar Formation After Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Baruch Padeh Medical Center, Poriya

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Among all other abdominal operations cesarean section is unique in two aspects. First, the requirement for rapid and as painless as possible recovery is not only important for the general good reasons, but there is the newborn baby, who needs maternal care. Second, in many cases the operation recurs in the same site, which may involve higher level of post operative pain. Application of local anesthetics to the incision site have been tried for abdominal operation in several forms, ranging from pre-incision injection (1-6) through post incision injection (7 ) to indwelling catheter for protracted instillation (8-9). Where tried, these methods mostly contributed to the reduction of post operative pain and patients' satisfaction, although there is no consensus as to its efficacy. Yet, local, pre-incision injection of local anesthetics has not been tested for cesarean section. The above not withstanding, it has been proposed that local infiltration of tissue with xylocaine may interfere with wound healing (10-11). Others suggested possible benefit due to antimicrobial activity (12) Conversely, Al- Asfour et al. (13) found no effect of topical oral application of xylocaine on experimental wounds in rabbits. Interestingly, Drucker et al. found that less collagen was deposited in healing wounds that were infiltrated with xylocaine prior to incision, while the strength of the scar was not affected (14-15). Our proposed study will examine whether pre-incision infiltration of the skin cut site can attenuate post operative pain after a cesarean section. It will also examine possible effect of this infiltration of parameters of wound heeling and scar formation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Relief
Keywords
Xylocaine, Casarean section, Post operative pain, Scar quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xylocaine
Arm Type
Experimental
Arm Description
Participants will receive local injection of 20 ml 1% Xylocaine to the skin incision site
Arm Title
Controls
Arm Type
Placebo Comparator
Arm Description
Participants will receive injection of 0.9% NaCl 20 ml to the incision site
Intervention Type
Drug
Intervention Name(s)
Local, pre-incisional injection of 20 ml 1% xylocaine
Intervention Description
Local, pre-incisional injection of 20 ml 1% xylocaine
Primary Outcome Measure Information:
Title
Level of post operative pain on a visual analog scale
Time Frame
Up to 48 hours postoperative
Secondary Outcome Measure Information:
Title
Appearance of operative scar, compared to previous scar
Time Frame
6-8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Candidates for non-emergency cesarean section Exclusion Criteria: Emergency cesarean section Known or suspected sensitivity to local anesthetics Pre-eclamptic toxemia Deranged liver function Deranged hemostasis Lack of adequate verbal communication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Izhar Ben-Shlomo, MD
Phone
972-50-6268024
Email
izharbs@netvision.net.il
First Name & Middle Initial & Last Name or Official Title & Degree
Aviva Peleg, MSc
Phone
972-50-6267521
Email
apeleg@poria.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Izhar Ben-Shlomo, MD
Organizational Affiliation
Department of Obstetrics & Gynecology, Baruch Padeh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics & Gynecology, Baruch Padeh Medical Center
City
Poriya
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Izhar Ben-Shlomo, MD
Phone
972-50-6268024
Email
izharbs@netvision.net.il
First Name & Middle Initial & Last Name & Degree
Aviva Peleg, MSc
Phone
972-50-6267521
Email
apeleg@poria.health.gov.il
First Name & Middle Initial & Last Name & Degree
Izhar Ben-Shlomo, MD
First Name & Middle Initial & Last Name & Degree
Nimrod Weitzman, MD
First Name & Middle Initial & Last Name & Degree
Dmitri Chuyun, MD
First Name & Middle Initial & Last Name & Degree
Moshe Ben-Ami, MD, Prof.

12. IPD Sharing Statement

Learn more about this trial

The Effect of Pre-incisional Local Xylocaine Injection on Post Operative Pain and Scar Formation After Cesarean Section

We'll reach out to this number within 24 hrs