İntroduction The World Health Organisation (WHO) and United Nations Children's Fund
(UNICEF) recommends that infants are exclusively breastfed for a minimum of 6 months,
with continued breastfeeding recommended until child age of 2 years or over to optimize
growth, development, and health. Breast milk shows significant benefits for the physical
and mental health of mothers and infants, including the promotion of maternal and infant
bonding, the reduction of neonatal mortality, the reduction of maternal postoperative
complications, and the development of newborns. Breastfeeding has been associated with
improved maternal/infant bonding and increased child intelligence. In addition
breastfeeding has many benefits for infant, mother and later child health.
The World Health Organization (WHO) and the United Nations Children's Fund (UNICEF)
recommend initiation of breastfeeding within the first hour of birth, referred to as
"early initiation of breastfeeding." Early initiation of breastfeeding is critical to
newborn survival and to establish breastfeeding practice over the long term. When
breastfeeding is delayed after birth, the consequences can be life-threatening and the
longer newborns are left waiting, the greater the risk.
It is also clear that medical interventions during labor and birth, including a caesarean
section, impact on women's infant feeding decisions and are a cause for concern given
increasing global caesarean birth rates, with woman who have a planned caesarean birth
reported as less likely to intend to breastfeed than women who did not have a planned
caesarean birth or had a vaginal birth. Infrequent feeding and women's limited mobility
in the early days following surgery may impede efforts to provide basic infant care. High
levels of postoperative pain, particularly in the first 24 hrs, were also found to have a
negative impact on women's breastfeeding experiences. Cesarean delivery is linked with
lower rates of early breastfeeding initiation.
Pain management after casarean delivery remains challenging. The best-accepted
traditional analgesic approach is continuous epidural analgesia. However, epidural
analgesia is rapidly being replaced by transversus abdominis plane (TAP) blocks. TAP
infiltration is an alternative to epidural blocks for providing postoperative analgesia
to the anterior abdominal wall. TAP infiltrations are relatively easy to perform,
generally safe, and can be performed in patients who are anti-coagulated. TAP
infiltration can be performed as a single injection, or a catheter can be inserted for
continuous local anesthetic infusion.
We therefore proposed to compare impact of TAP block, epidural analgesia and iv
multimodal analgesia after spinal analgesia on maternal comfort in patients with elective
caesarean section. We will evaluate the following specific aims, all of which will be
assessed over 72 hours, or the duration of hospitalization if shorter:
Primary Aim: To compare the effect of pain management after cesarean on the rates of
initiation of breastfeeding in the first hour after birth and exclusive breast milk in
the first 72 hours in elective cesarean deliveries with spinal anesthesia.
Secondary Aim 1: To compare the effect of pain management after cesarean on the rates of
the confidence and comfort of breastfeeding mothers after elective cesarean deliveries
with spinal anesthesia.
Hypothesis. Four quadrant TAP blocks performed after elective inert cesarean section
increase the rate of breastfeeding in the first 1 hour and the rate of exclusive
breastfeeding in the first 72 hours.
- Method and Study Design A. Study Overview A randomized double-blind trial is
designed comparing TAP blocks , epidural analgesia and ıv multimodal analgesia and
placebo in patients having elective inert cesarean deviveries with spinal
anesthesia. The study will be performed at Konya City Hospital with IRB approval and
written consent from patients.
B. Setting and Population
Inclusion criteria:
Written informed consent;
18-45 years old;
ASA Physical Status 1-3;
Scheduled for elective cesarien delivery;
Anticipated hospitalization of at least three nights;
Expected requirement for parenteral opioids for at least 72 hours for postoperative
pain;
Able to use IV PCA systems.
Exclusion criteria:
Hepatic disease, e.g. twice the normal levels of liver enzymes;
Kidney disease, e.g. twice the normal level of serum creatinine;
Bupivacaine sensitivity or known allergy;
Anticoagulants considered to be a contraindication for TAP blocks;
Surgeries with high port sites;
C. Withdrawal Criteria Patients will be free to withdraw from study at any time. Patients
will also be removed from study at any time for adverse events, or deemed necessary for
patient safety.