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

Postoperative Pain Clinical Trial

— TAP-CAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102515
• Other study ID #: 2016-A00131-50
• Status: Completed
• Phase: Phase 4
• Start date: May 29, 2016
• Est. completion date: October 26, 2016

Study information

• Verified date: March 2017
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: October 26, 2016
• Est. primary completion date: October 26, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• USG-TAP block

• CIC

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Cumulative dose of Tramadol during the first 3 days		during the first 3 days
Secondary	Cumulative dose of nefopam during the first 3 days		during the first 3 days
Secondary	Cumulative dose of oxycodone during the first 3 days		during the first 3 days
Secondary	patient comfort assessed daily by visual analogic scale	by visual analogic scale	during the first 3 days