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

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Procedure: control; Procedure: TAP block

• Registration Number: NCT01674114
• Lead Sponsor: St. Olavs Hospital

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.

Study Timeline

• Study First Submitted: 2012-08-23
• Study First Submitted QC: 2012-08-27
• Study First Posted: 2012-08-28
• Study Start: 2012-09
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-13
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

Inclusion Criteria

• pregnant women that are scheduled for elective C-section

Exclusion Criteria

• relevant drug allergy
• history of drug abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	control	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)
TAP block	TAP block	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

Primary Outcome Measures

Name	Time	Method
total amount of morphine consumption	48 hours	patient controlled analgesia (PCA-pump)

Secondary Outcome Measures

Name	Time	Method
time to first bolus request	up to 48 hours
cumulative morphine consumption	36 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

Trial Locations

Locations (1)

St Olavs Hospital; 🇳🇴 Trondheim, Norway