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

Sponsor
University Hospital, Caen (Other)
Overall Status
Completed
CT.gov ID
NCT03102515
Collaborator
(none)
109
Enrollment
2
Arms
4.9
Actual Duration (Months)

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
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 :
Oct 26, 2016
Actual Study Completion Date :
Oct 26, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: Spinal-anesthesia

Caesarean section performed under spinal anaesthesia and receiving either USG-TAP block or CIC

Drug: USG-TAP block

Drug: CIC
Other: Epidural-anesthesia

Caesarean section performed under epidural anaesthesia and receiving either USG-TAP block or CIC

Drug: USG-TAP block

Drug: CIC

Outcome Measures

Primary Outcome Measures

  1. Postoperative standing pain at day 2 [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 [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 [during the first 3 days]

  3. Cumulative dose of nefopam during the first 3 days [during the first 3 days]

  4. Cumulative dose of oxycodone during the first 3 days [during the first 3 days]

  5. patient comfort assessed daily by visual analogic scale [during the first 3 days]

    by visual analogic scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT03102515
Other Study ID Numbers:
  • 2016-A00131-50
First Posted:
Apr 5, 2017
Last Update Posted:
Sep 1, 2020
Last Verified:
Mar 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pain, Postoperative

Study Results

No Results Posted as of Sep 1, 2020