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

Pain Relief Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00914498
• Other study ID #: Xylocaine CS Scar.CTIL
• Status: Recruiting
• Phase: N/A
• First received: June 4, 2009
• Last updated: August 23, 2009
• Start date: July 2009

Study information

• Verified date: August 2009
• Source: The Baruch Padeh Medical Center, Poriya
• Contact: Izhar Ben-Shlomo, MD
• Phone: 972-50-6268024
• Email: izharbs[@]netvision.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain Relief
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Israel	Department of Obstetrics & Gynecology, Baruch Padeh Medical Center	Poriya

Sponsors (1)

Lead Sponsor	Collaborator
The Baruch Padeh Medical Center, Poriya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of post operative pain on a visual analog scale		Up to 48 hours postoperative	No
Secondary	Appearance of operative scar, compared to previous scar		6-8 weeks	No