Treatment
To evaluate the effect of continuous ropivacaine subfascial wound
infusion after caesarean delivery patients were randomly allocated in
two groups receiving either ropivacaine 0.2 % (Ropivacaine, 2 mg/ml,
Fresensius Kabi) (ropivacaine group) or NaCl 0.9 % (placebo group) into
the wound catheter. Group allocation was done using a computer-generated
randomization and was concealed in sealed envelopes until start of
surgery. Based on this information, a fix member of the midwife team who
will otherwise not be involved in the study, prepared the injections for
the elastomeric pump with either ropivacaine 0.2 % or NaCl 0.9 % so
that only they were aware of the product that was administered through
the catheter.
At the time of surgery, all of the patients received a standardized
spinal anaesthesia with 8 - 10 mg of hyperbaric bupivacaine 0.5 %
(Marcaine, AstraZeneca) combined with 2 - 2.5 μg of sufentanil (Sufenta,
Janssens-Cilag) based on clinicians’ discretion. If inadequate spinal
anaesthesia occurred, general anaesthesia was performed, and the patient
had been excluded from the study.
All caesarean sections were done by Pfannenstiel incision followed by
transverse lower uterine segment incision. Near the end of the procedure
the parietal peritoneum was closed with a running absorbable suture.
After this, a multi-holded catheter (PAINfusor catheter 15 cm; Baxter,
Amaro, Italy) was placed along the full length of the wound between the
closed parietal peritoneum and the fascia transversalis. In the end, the
gynaecologist closed the fascial layer and skin followed by securing the
catheter to the skin. A 5 ml solution, ropivacaine 0.2 % or NaCl 0.9
%, depending on group allocation, was administered through the catheter
during the surgical intervention to evaluate his permeability. In the
ropivacaine group, ropivacaine 0.2 % was injected through the catheter,
by an elastomeric pump infusor (Infusor LV 7 mL/h; Baxter) at a rate of
7 ml/h for 48 hours. In the placebo group, NaCl 0.9 % was injected
through the catheter, by an elastomeric pump infusor at a rate of 7 ml/h
for 48 hours.
Post caesarean, all patients received a strictly identical multimodal
analgesic treatment.
A patient-controlled analgesia (PCA) device (CADD, Solis 2110, Smiths
Medical, St. Paul, USA) was placed in the postanesthesia care unit
(PACU) and set to deliver a 2 mg dose of morphine with a 10-minute
lockout time and a maximum allowed dose of 20 mg per 4 hours.
Paracetamol 1 g four times a day and diclofenac 75 mg two times a day,
both intravenous administrated, were systematically given in the first
48 hours. After 48 hours, the PCA device and all other intravenous
therapies were stopped, and oral analgesics were given on demand based
on the WHO ladder. Rescue intravenous antiemetics (metoclopramide 10 mg
and if insufficient ondansetron 4 mg) were administered if postoperative
nausea/vomiting developed. Pruritus was treated by subcutaneous naloxone
(0.4 mg) administration.
Pre-operative ulcer prevention (ranitidine 150 mg) and post-operative
thromboembolism prophylaxis (enoxaparine 0.4 ml) was performed according
to international guidelines.
Urine bladder catheter was left in place for at least 24 hours after
surgery.