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

NCT ID: NCT01674114

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-06-30

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.

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

TAP block

Intervention Type: PROCEDURE

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)

Group Type: ACTIVE_COMPARATOR

control

Intervention Type: PROCEDURE

Interventions

TAP block

Intervention Type: PROCEDURE

control

Intervention Type: PROCEDURE

Other Intervention Names

intracutaneous infiltration

Eligibility Criteria

Inclusion Criteria

• pregnant women that are scheduled for elective C-section

Exclusion Criteria

• relevant drug allergy
• history of drug abuse

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aage Telnes, MD

Role: PRINCIPAL_INVESTIGATOR

St. Olavs Hospital

Locations

St Olavs Hospital

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: RESULT

PMID: 25786679 (View on PubMed)

Other Identifiers

2012-1

Identifier Type: -

Identifier Source: org_study_id