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Completed

NCT Number: NCT01674114

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

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.

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Key information

Conditions

Pregnancy

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital

Trondheim, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant women that are scheduled for elective C-section

Exclusion criteria

  • relevant drug allergy
  • history of drug abuse

Treatment and study plan

TAP Block

Procedure

Control

Procedure

Other names: intracutaneous infiltration

Primary outcomes

  1. total amount of morphine consumption

    Time frame: 48 hours

    patient controlled analgesia (PCA-pump)

Secondary outcomes

  1. time to first bolus request

    Time frame: up to 48 hours

  2. cumulative morphine consumption

    Time frame: 12 hours

  3. cumulative morphine consumption

    Time frame: 24 hours

  4. cumulative morphine consumption

    Time frame: 36 hours

  5. pain

    Time frame: up to 48 hours

    Visual Analog Scale 0-10

  6. side effects

    Time frame: up to 48 hours

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

Other outcomes

  1. anti-emetics

    Time frame: up to 48 hours

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

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 28, 2012
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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