Transversus Abdominis Plane Block vs Continuous Infiltration Wound Catheter for Analgesia After Caesarean Section: a Randomized Trial. (TAP-CAT Study)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University Hospital, Caen
- Enrollment
- 109
- Primary Endpoint
- Postoperative standing pain at day 2
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Spinal-anesthesia
Caesarean section performed under spinal anaesthesia and receiving either USG-TAP block or CIC
Intervention: USG-TAP block (Drug)
Spinal-anesthesia
Caesarean section performed under spinal anaesthesia and receiving either USG-TAP block or CIC
Intervention: CIC (Drug)
Epidural-anesthesia
Caesarean section performed under epidural anaesthesia and receiving either USG-TAP block or CIC
Intervention: USG-TAP block (Drug)
Epidural-anesthesia
Caesarean section performed under epidural anaesthesia and receiving either USG-TAP block or CIC
Intervention: CIC (Drug)
Outcomes
Primary Outcomes
Postoperative standing pain at day 2
Time Frame: Evaluate standing pain at 48 hours postoperatively
Assessment of Pain on Mobilization by a Numeric Scale of Pain
Secondary Outcomes
- 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)
- 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 oxycodone during the first 3 days(during the first 3 days)