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

Baruch Padeh Medical Center

Status: Unknown

Conditions: Pain Relief

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00914498

Xylocaine CS Scar.CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Xylocaine

Experimental group

Description:

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

Treatment:

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

Controls

Placebo Comparator group

Description:

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

Treatment:

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