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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain Relief

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Xylocaine

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Controls

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

Group Type PLACEBO_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No