Transversus Abdominis Plane Block vs Continuous Infiltration Wound Catheter for Analgesia After Caesarean Section (TAP-CAT)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
USG-TAP block
CIC
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Spinal-anesthesia
Epidural-anesthesia
Arm Description
Caesarean section performed under spinal anaesthesia and receiving either USG-TAP block or CIC
Caesarean section performed under epidural anaesthesia and receiving either USG-TAP block or CIC
Outcomes
Primary Outcome Measures
Postoperative standing pain at day 2
Assessment of Pain on Mobilization by a Numeric Scale of Pain
Secondary Outcome Measures
standing and resting pain measured during the first 3 days
Assessment of Pain by a Numeric Scale of Pain
Cumulative dose of Tramadol during the first 3 days
Cumulative dose of nefopam during the first 3 days
Cumulative dose of oxycodone during the first 3 days
patient comfort assessed daily by visual analogic scale
by visual analogic scale
Full Information
NCT ID
NCT03102515
First Posted
March 31, 2017
Last Updated
August 31, 2020
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT03102515
Brief Title
Transversus Abdominis Plane Block vs Continuous Infiltration Wound Catheter for Analgesia After Caesarean Section
Acronym
TAP-CAT
Official Title
Transversus Abdominis Plane Block vs Continuous Infiltration Wound Catheter for Analgesia After Caesarean Section: a Randomized Trial. (TAP-CAT Study)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 29, 2016 (Actual)
Primary Completion Date
October 26, 2016 (Actual)
Study Completion Date
October 26, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spinal-anesthesia
Arm Type
Other
Arm Description
Caesarean section performed under spinal anaesthesia and receiving either USG-TAP block or CIC
Arm Title
Epidural-anesthesia
Arm Type
Other
Arm Description
Caesarean section performed under epidural anaesthesia and receiving either USG-TAP block or CIC
Intervention Type
Drug
Intervention Name(s)
USG-TAP block
Intervention Type
Drug
Intervention Name(s)
CIC
Primary Outcome Measure Information:
Title
Postoperative standing pain at day 2
Description
Assessment of Pain on Mobilization by a Numeric Scale of Pain
Time Frame
Evaluate standing pain at 48 hours postoperatively
Secondary Outcome Measure Information:
Title
standing and resting pain measured during the first 3 days
Description
Assessment of Pain by a Numeric Scale of Pain
Time Frame
Evaluate pain at during 3 days postoperatively
Title
Cumulative dose of Tramadol during the first 3 days
Time Frame
during the first 3 days
Title
Cumulative dose of nefopam during the first 3 days
Time Frame
during the first 3 days
Title
Cumulative dose of oxycodone during the first 3 days
Time Frame
during the first 3 days
Title
patient comfort assessed daily by visual analogic scale
Description
by visual analogic scale
Time Frame
during the first 3 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Transversus Abdominis Plane Block vs Continuous Infiltration Wound Catheter for Analgesia After Caesarean Section
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