NCT01674114

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

August 23, 2012

Last Update Submit

January 13, 2017

Conditions

Pregnancy

Keywords

Cesarean SectionAnesthetics, Local

Outcome Measures

Primary Outcomes (1)

  • total amount of morphine consumption

    patient controlled analgesia (PCA-pump)

    48 hours

Secondary Outcomes (6)

  • 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

    up to 48 hours

  • +1 more secondary outcomes

Other Outcomes (1)

  • anti-emetics

    up to 48 hours

Study Arms (2)

TAP block

EXPERIMENTAL

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

control

ACTIVE COMPARATOR

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

Interventions

TAP blockPROCEDURE
TAP block
controlPROCEDURE
Also known as: intracutaneous infiltration
control

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women that are scheduled for elective C-section

You may not qualify if:

  • relevant drug allergy
  • history of drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

  • 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.

    PMID: 25786679RESULT

Study Officials

  • Aage Telnes, MD

    St. Olavs Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2012

First Posted

August 28, 2012

Study Start

September 1, 2012

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

NO(1)