Clinical trial NCT00914498: The Effect of Pre-incisional Local Xylocaine Injection on Post Operative Pain and Scar Formation After Cesarean Section
Official title: The Effect of Pre-incisional Local Xylocaine Injection on Post Operative Pain and Scar Formation After Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain Relief
Keywords: Xylocaine
Casarean section
Post operative pain
Scar quality
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
First posted: 2009-06-05
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Level of post operative pain on a visual analog scale
timeFrame: Up to 48 hours postoperative
Secondary outcomes:
measure: Appearance of operative scar, compared to previous scar
timeFrame: 6-8 weeks
Other outcomes:
Locations:
city: Poriya
country: Israel
facility: Department of Obstetrics & Gynecology, Baruch Padeh Medical Center
Study officials:
affiliation: Department of Obstetrics & Gynecology, Baruch Padeh Medical Center
name: Izhar Ben-Shlomo, MD
role: PRINCIPAL_INVESTIGATOR
References: