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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: USG-TAP block; Drug: CIC

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative standing pain at day 2	Assessment of Pain on Mobilization by a Numeric Scale of Pain	Evaluate standing pain at 48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
standing and resting pain measured during the first 3 days	Assessment of Pain by a Numeric Scale of Pain	Evaluate pain at during 3 days postoperatively
Cumulative dose of Tramadol during the first 3 days		during the first 3 days
Cumulative dose of nefopam during the first 3 days		during the first 3 days
Cumulative dose of oxycodone during the first 3 days		during the first 3 days
patient comfort assessed daily by visual analogic scale	by visual analogic scale	during the first 3 days

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2016
• Primary Completion (Actual): October 26, 2016
• Study Completion (Actual): October 26, 2016

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 5, 2017

Study Record Updates

• Last Update Posted (Actual): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2016-A00131-50

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No