Pain Relief Clinical Trial
Official title:
The Effect of Pre-incisional Local Xylocaine Injection on Post Operative Pain and Scar Formation After Cesarean Section
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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