Postoperative Morphine Consumption After Caesarean Section- TAP Block vs Intracutaneous Infiltration

Study Overview
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Brief Summary
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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
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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.

Official Title
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Postoperative Morphine Consumption After Caesarean Section- TAP Block vs Intracutaneous Infiltration

Conditions
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Pregnancy

Intervention / Treatment
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* Procedure: TAP block
* Procedure: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant women that are scheduled for elective C-section Exclusion Criteria: relevant drug allergy history of drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP block<br>transversus abdominis plane block (TAP block). Ultrasound guided TAP-block at the end of surgery using 20 ml bupivacaine 0,25% with Adrenaline 5mcg/ml bilaterally by the anaesthesiologist, and 20 ml NaCl intracutaneously in the operating wound performed by the obstetrician | Procedure: TAP block<br> <br> |
| Active Comparator: control<br>Ultrasound guided TAP block at the end of surgery with 20 ml NaCl bilaterally and 20 ml bupivacaine 0,25% with Adrenaline 5mcg/ml intracutaneously in the surgical wound(standard practice) | Procedure: control<br> <br> * Other names: intracutaneous infiltration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total amount of morphine consumption | patient controlled analgesia (PCA-pump) | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to first bolus request |  | up to 48 hours | 
| cumulative morphine consumption |  | 12 hours | 
| cumulative morphine consumption |  | 24 hours | 
| cumulative morphine consumption |  | 36 hours | 
| pain | Visual Analog Scale 0-10 | up to 48 hours | 
| side effects | nausea, vomiting, pruritus and sedation on a 4 point scale as none, mild, moderate and severe | up to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean Section, Anesthetics, Local