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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00914498
Enrollment
120
Registered
2009-06-05
Start date
2009-07-31
Completion date
Unknown
Last updated
2009-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Relief

Keywords

Xylocaine, Casarean section, Post operative pain, Scar quality

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.

Interventions

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

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

Sponsors

The Baruch Padeh Medical Center, Poriya
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Level of post operative pain on a visual analog scaleUp to 48 hours postoperative

Secondary

MeasureTime frame
Appearance of operative scar, compared to previous scar6-8 weeks

Countries

Israel

Contacts

Primary ContactIzhar Ben-Shlomo, MD
izharbs@netvision.net.il972-50-6268024
Backup ContactAviva Peleg, MSc
apeleg@poria.health.gov.il972-50-6267521

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026