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

Sponsor
St. Olavs Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01674114
Collaborator
Norwegian University of Science and Technology (Other)
57
1
2
9
6.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: TAP block
  • Procedure: control
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Postoperative Morphine Consumption After Caesarean Section- TAP Block vs Intracutaneous Infiltration
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Procedure: TAP block

Active Comparator: 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)

Procedure: control
Other Names:
  • intracutaneous infiltration
  • Outcome Measures

    Primary Outcome Measures

    1. total amount of morphine consumption [48 hours]

      patient controlled analgesia (PCA-pump)

    Secondary Outcome Measures

    1. time to first bolus request [up to 48 hours]

    2. cumulative morphine consumption [12 hours]

    3. cumulative morphine consumption [24 hours]

    4. cumulative morphine consumption [36 hours]

    5. pain [up to 48 hours]

      Visual Analog Scale 0-10

    6. side effects [up to 48 hours]

      nausea, vomiting, pruritus and sedation on a 4 point scale as none, mild, moderate and severe

    Other Outcome Measures

    1. anti-emetics [up to 48 hours]

      Antiemetics will not be given routinely, and its use will therefore also be registered

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • pregnant women that are scheduled for elective C-section
    Exclusion Criteria:
    • relevant drug allergy

    • history of drug abuse

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St Olavs Hospital Trondheim Norway

    Sponsors and Collaborators

    • St. Olavs Hospital
    • Norwegian University of Science and Technology

    Investigators

    • Principal Investigator: Aage Telnes, MD, St. Olavs Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    St. Olavs Hospital
    ClinicalTrials.gov Identifier:
    NCT01674114
    Other Study ID Numbers:
    • 2012-1
    First Posted:
    Aug 28, 2012
    Last Update Posted:
    Jan 18, 2017
    Last Verified:
    Jan 1, 2017
    Keywords provided by St. Olavs Hospital

    Study Results

    No Results Posted as of Jan 18, 2017