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

NCT03102515 | Completed Phase 4

• 1 other identifier: 2016-A00131-50
• Study Type: interventional
• Target: 109
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• standing and resting pain measured during the first 3 days

  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

  during the first 3 days

Study Arms (2)

Spinal-anesthesia

OTHER

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

Drug: USG-TAP block; Drug: CIC

Epidural-anesthesia

OTHER

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

Drug: USG-TAP block; Drug: CIC

Interventions

USG-TAP block DRUG

Epidural-anesthesia; Spinal-anesthesia

CIC DRUG

Epidural-anesthesia; Spinal-anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent,
• Age\>/=18 years,
• Caesarean section under spinal or epidural anaesthesia
• Technique surgical "Cohen Stark méthod".

You may not qualify if:

• Patient refusal,
• Patient under guardianship,
• Contraindication to one of the two techniques,
• Cesarean section under general anesthesia
• Allergies to local anesthetics
• Maternal instability

Sponsors & Collaborators

• University Hospital, Caen: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 5, 2017
• Study Start: May 29, 2016
• Primary Completion: October 26, 2016
• Study Completion: October 26, 2016
• Last Updated: September 1, 2020

Record last verified: 2017-03