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Transversus Abdominis Plane Block vs Continuous Infiltration Wound Catheter for Analgesia After Caesarean Section (TAP-CAT)

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ClinicalTrials.gov Identifier: NCT03102515
Recruitment Status : Completed
First Posted : April 5, 2017
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: USG-TAP block Drug: CIC Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Official Title: Transversus Abdominis Plane Block vs Continuous Infiltration Wound Catheter for Analgesia After Caesarean Section: a Randomized Trial. (TAP-CAT Study)
Actual Study Start Date : May 29, 2016
Actual Primary Completion Date : October 26, 2016
Actual Study Completion Date : October 26, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Spinal-anesthesia
Caesarean section performed under spinal anaesthesia and receiving either USG-TAP block or CIC
Drug: USG-TAP block
Drug: CIC
Epidural-anesthesia
Caesarean section performed under epidural anaesthesia and receiving either USG-TAP block or CIC
Drug: USG-TAP block
Drug: CIC



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03102515     History of Changes
Other Study ID Numbers: 2016-A00131-50
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs