Clinical trial NCT01674114: Postoperative Morphine Consumption After Caesarean Section- TAP Block vs Intracutaneous Infiltration
Official title: Postoperative Morphine Consumption After Caesarean Section- TAP Block vs Intracutaneous Infiltration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Cesarean Section
Anesthetics, Local
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2012-08-28
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* pregnant women that are scheduled for elective C-section

Exclusion Criteria:

* relevant drug allergy
* history of drug abuse

Primary outcomes:
measure: total amount of morphine consumption
timeFrame: 48 hours
Secondary outcomes:
measure: time to first bolus request
timeFrame: up to 48 hours
measure: cumulative morphine consumption
timeFrame: 12 hours
measure: cumulative morphine consumption
timeFrame: 24 hours
measure: cumulative morphine consumption
timeFrame: 36 hours
measure: pain
timeFrame: up to 48 hours
measure: side effects
timeFrame: up to 48 hours
Other outcomes:
measure: anti-emetics
timeFrame: up to 48 hours
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Aage Telnes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Telnes A, Skogvoll E, Lonnee H. Transversus abdominis plane block vs. wound infiltration in Caesarean section: a randomised controlled trial. Acta Anaesthesiol Scand. 2015 Apr;59(4):496-504. doi: 10.1111/aas.12498.