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

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ClinicalTrials.gov Identifier: NCT00914498
Recruitment Status : Unknown
Verified August 2009 by The Baruch Padeh Medical Center, Poriya.
Recruitment status was:  Recruiting
First Posted : June 5, 2009
Last Update Posted : August 25, 2009
Sponsor:
Information provided by:
The Baruch Padeh Medical Center, Poriya

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.

Condition or disease Intervention/treatment Phase
Pain Relief Drug: Local, pre-incisional injection of 20 ml 1% xylocaine Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Pre-incisional Local Xylocaine Injection on Post Operative Pain and Scar Formation After Cesarean Section
Study Start Date : July 2009
Estimated Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Xylocaine
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
Local, pre-incisional injection of 20 ml 1% xylocaine
Placebo Comparator: Controls
Participants will receive injection of 0.9% NaCl 20 ml to the incision site
Drug: Local, pre-incisional injection of 20 ml 1% xylocaine
Local, pre-incisional injection of 20 ml 1% xylocaine



Primary Outcome Measures :
  1. Level of post operative pain on a visual analog scale [ Time Frame: Up to 48 hours postoperative ]

Secondary Outcome Measures :
  1. Appearance of operative scar, compared to previous scar [ Time Frame: 6-8 weeks ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914498


Contacts
Contact: Izhar Ben-Shlomo, MD 972-50-6268024 izharbs@netvision.net.il
Contact: Aviva Peleg, MSc 972-50-6267521 apeleg@poria.health.gov.il

Locations
Israel
Department of Obstetrics & Gynecology, Baruch Padeh Medical Center Recruiting
Poriya, Israel
Contact: Izhar Ben-Shlomo, MD    972-50-6268024    izharbs@netvision.net.il   
Contact: Aviva Peleg, MSc    972-50-6267521    apeleg@poria.health.gov.il   
Principal Investigator: Izhar Ben-Shlomo, MD         
Sub-Investigator: Nimrod Weitzman, MD         
Sub-Investigator: Dmitri Chuyun, MD         
Sub-Investigator: Moshe Ben-Ami, MD, Prof.         
Sponsors and Collaborators
The Baruch Padeh Medical Center, Poriya
Investigators
Principal Investigator: Izhar Ben-Shlomo, MD Department of Obstetrics & Gynecology, Baruch Padeh Medical Center

Responsible Party: Izhar Ben-Shlomo, MD, Senior Obstetrician & Gynecologist, The Baruch Padeh Medical Center
ClinicalTrials.gov Identifier: NCT00914498     History of Changes
Other Study ID Numbers: Xylocaine CS Scar.CTIL
First Posted: June 5, 2009    Key Record Dates
Last Update Posted: August 25, 2009
Last Verified: August 2009

Keywords provided by The Baruch Padeh Medical Center, Poriya:
Xylocaine
Casarean section
Post operative pain
Scar quality

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action