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

NCT ID: NCT03102515

Last Updated: 2020-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-29
• Study Completion Date: 2016-10-26

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT

Study Groups

Spinal-anesthesia

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

Group Type: OTHER

USG-TAP block

Intervention Type: DRUG

CIC

Intervention Type: DRUG

Epidural-anesthesia

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

Group Type: OTHER

USG-TAP block

Intervention Type: DRUG

CIC

Intervention Type: DRUG

Interventions

USG-TAP block

Intervention Type: DRUG

CIC

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2016-A00131-50

Identifier Type: -

Identifier Source: org_study_id