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

Condition(s) targeted: Pain Relief

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

Phase: N/A

Status: Recruiting

Sponsored by: The Baruch Padeh Medical Center, Poriya

Official(s) and/or principal investigator(s):
Izhar Ben-Shlomo, MD, Principal Investigator, Affiliation: Department of Obstetrics & Gynecology, Baruch Padeh Medical Center

Overall contact:
Izhar Ben-Shlomo, MD, Phone: 972-50-6268024, Email: izharbs@netvision.net.il

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.

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

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

Primary outcome: Level of post operative pain on a visual analog scale

Secondary outcome: Appearance of operative scar, compared to previous scar

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.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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

Izhar Ben-Shlomo, MD, Phone: 972-50-6268024, Email: izharbs@netvision.net.il

Department of Obstetrics & Gynecology, Baruch Padeh Medical Center, Poriya, Israel; Recruiting
Izhar Ben-Shlomo, MD, Phone: 972-50-6268024, Email: izharbs@netvision.net.il
Aviva Peleg, MSc, Phone: 972-50-6267521, Email: apeleg@poria.health.gov.il
Izhar Ben-Shlomo, MD, Principal Investigator
Nimrod Weitzman, MD, Sub-Investigator
Dmitri Chuyun, MD, Sub-Investigator
Moshe Ben-Ami, MD, Prof., Sub-Investigator

Starting date: July 2009
Last updated: August 23, 2009