Pregnancy
Conditions
Keywords
Cesarean Section, Anesthetics, Local
Brief summary
The purpose of this study is to investigate whether a regional-block (TAP block) in Caesarean section will give a measurable benefit in form of reducing Morphine consumption as compared to local infiltration of the wound with local anesthetic.
Detailed description
Caesarean section is one of the most common surgical procedures in the world and postoperative pain afflicts both mother and the newborn- especially the first 48 hours after birth. Pain management at the investigators hospital is multimodal (balanced analgesia). Peroperatively the wound is infiltrated with local anaesthetic performed by the obstetrician at the end of the procedure. Postoperatively the patient gets routinely a combination of Paracetamol and NSAID's orally and Morphine intravenously as required. The side-effects of Morphine (nausea, vomiting, itching and sedation) do interfere, dose dependent, with the interaction between mother and child, breastfeeding and postpartum experience. Previous studies have compared transversus abdominis plane block (TAP block) with reduction of morphine consumption in C-section (up to 50%! (1,2). So far no one has compared TAP-block with local infiltration in C-section patients. Ultrasound guided TAP-block is done by an anaesthesiologist at the end of the operation, and it is viewed as a safe and easy procedure to perform. The investigators assumption is that the TAP-block reduces the morphine consumption with 50% as compared to local infiltration. Due to maximal dosage of Bupivacaine, it is not possible to give both types of anaesthesia at the same time.
Interventions
PROCEDURETAP block
PROCEDUREcontrol
Sponsors
Norwegian University of Science and Technology
St. Olavs Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* pregnant women that are scheduled for elective C-section
Exclusion criteria
* relevant drug allergy * history of drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total amount of morphine consumption | 48 hours | patient controlled analgesia (PCA-pump) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to first bolus request | up to 48 hours | — |
| cumulative morphine consumption | 12 hours | — |
| pain | up to 48 hours | Visual Analog Scale 0-10 |
| side effects | up to 48 hours | nausea, vomiting, pruritus and sedation on a 4 point scale as none, mild, moderate and severe |
Other
| Measure | Time frame | Description |
|---|---|---|
| anti-emetics | up to 48 hours | Antiemetics will not be given routinely, and its use will therefore also be registered |
Countries
Norway
Outcome results
None listed