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Completed

NCT Number: NCT03102515

Transversus Abdominis Plane Block vs Continuous Infiltration Wound Catheter for Analgesia After Caesarean Section

Analgesia following surgery associates different intra-venous or oral analgesic drugs and sometimes opioids. To reduce opioid consumption, loco-regional anaesthesia might be administered as a complement. In the specific context of caesarean sections, pain control is mandatory to enable the mother to take care of her offspring and shorten their hospital stay. This intervention is mainly performed under neuraxial anaesthesia (spinal or epidural), enabling the injection of morphine in the subdural or epidural space, as part of a multimodal analgesia regimen.

Studies have evaluated continuous wound infiltration catheters (CIC) and ultrasound-guided (UGD) transabdominis plane (TAP) block, and both techniques and both techniques reduce postoperative morphine consumption. Recent studies have compared the two techniques and found conflicting results. Furthermore, they did not consider caesarean section performed under epidural analgesia, with a different neuraxial injection site, neither did they compared pain after postoperative day 2.

Consequently, the aim of this study was to compare resting and standing pain up to postoperative day 3 after caesarean section performed under spinal or epidural anaesthesia and receiving either USG-TAP block or CIC. Baseline hypothesis was that the continuous infiltration provided a better analgesia at day 2.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent,
  • Age>/=18 years,
  • Caesarean section under spinal or epidural anaesthesia
  • Technique surgical "Cohen Stark méthod".

Exclusion criteria

  • Patient refusal,
  • Patient under guardianship,
  • Contraindication to one of the two techniques,
  • Cesarean section under general anesthesia
  • Allergies to local anesthetics
  • Maternal instability

Treatment and study plan

USG-TAP block

Drug

CIC

Drug

Primary outcomes

  1. Postoperative standing pain at day 2

    Time frame: Evaluate standing pain at 48 hours postoperatively

    Assessment of Pain on Mobilization by a Numeric Scale of Pain

Secondary outcomes

  1. standing and resting pain measured during the first 3 days

    Time frame: Evaluate pain at during 3 days postoperatively

    Assessment of Pain by a Numeric Scale of Pain

  2. Cumulative dose of Tramadol during the first 3 days

    Time frame: during the first 3 days

  3. Cumulative dose of nefopam during the first 3 days

    Time frame: during the first 3 days

  4. Cumulative dose of oxycodone during the first 3 days

    Time frame: during the first 3 days

  5. patient comfort assessed daily by visual analogic scale

    Time frame: during the first 3 days

    by visual analogic scale

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

Transversus Abdominis Plane Block vs Continuous Infiltration Wound Catheter for Analgesia After Caesarean Section: a Randomized Trial. (TAP-CAT Study)

Acronym: TAP-CAT

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 5, 2017
Registry last updated
Sep 1, 2020

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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