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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674114
• Other study ID #: 2012-1
• Status: Completed
• Phase: N/A
• First received: August 23, 2012
• Last updated: January 13, 2017
• Start date: September 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2017
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• pregnant women that are scheduled for elective C-section

Exclusion Criteria:

• relevant drug allergy

• history of drug abuse

Related Conditions & MeSH terms

• Pregnancy

Intervention

Procedure:
• TAP block

• control

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Telnes A, Skogvoll E, Lonnée 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	anti-emetics	Antiemetics will not be given routinely, and its use will therefore also be registered	up to 48 hours
Primary	total amount of morphine consumption	patient controlled analgesia (PCA-pump)	48 hours
Secondary	time to first bolus request		up to 48 hours
Secondary	cumulative morphine consumption		12 hours
Secondary	cumulative morphine consumption		24 hours
Secondary	cumulative morphine consumption		36 hours
Secondary	pain	Visual Analog Scale 0-10	up to 48 hours
Secondary	side effects	nausea, vomiting, pruritus and sedation on a 4 point scale as none, mild, moderate and severe	up to 48 hours