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

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: USG-TAP block; Drug: CIC

• Registration Number: NCT03102515
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-29
• Primary Completion: 2016-10-26
• Study Completion: 2016-10-26
• Status Verified: 2017-03
• Study First Submitted: 2017-03-31
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-05
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 109

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Spinal-anesthesia	USG-TAP block	Caesarean section performed under spinal anaesthesia and receiving either USG-TAP block or CIC
Spinal-anesthesia	CIC	Caesarean section performed under spinal anaesthesia and receiving either USG-TAP block or CIC
Epidural-anesthesia	USG-TAP block	Caesarean section performed under epidural anaesthesia and receiving either USG-TAP block or CIC
Epidural-anesthesia	CIC	Caesarean section performed under epidural anaesthesia and receiving either USG-TAP block or CIC

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Cumulative dose of nefopam during the first 3 days	during the first 3 days
patient comfort assessed daily by visual analogic scale	during the first 3 days	by visual analogic scale
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
Cumulative dose of Tramadol during the first 3 days	during the first 3 days
Cumulative dose of oxycodone during the first 3 days	during the first 3 days