NCT05686382

TAP Block vs CWI for Total Abdominal Hysterectomy, a RCT

Anestesia Generale + TAP Block vs Anestesia Generale + CWI Per Intervento di Isterectomia Totale Laparotomica. Trial Randomizzato Controllato.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Campus Bio-Medico University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This no-profit, monocentric, prospective randomized controlled trial, aims to demonstrate the non-inferiority of continuous wound infusion (CWI) when compared to transversus abdominis plane (TAP) block for postoperative pain control after total abdominal hysterectomy.

Detailed description

After signing the informed consent, patients will be enrolled and randomly allocated into either the study group (CWI) or the control group (TAP). Both groups will receive standard general anesthesia. At the end of the surgery, the CWI patients will receive a preperitoneal catheter in the surgical wound and CWI of ropivacaine 2 mg/ml, 5 ml/h for 24 hours; with the TAP block patients will receive a bilateral, standard lateral TAP block with 5 mg/ml ropivacaine 24 ml per side. All patients will receive multimodal analgesia with ketorolac 30 mg e.v. plus 90 mg/24h IV, paracetamol 1g plus 1g TID, dexamethasone 0,1 mg/kg IV preoperatively, oxycodone 5 mg per OS upon request.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
PROCEDURE	Continuous Wound Infusion	continuous local anesthetic infiltration of the wound
PROCEDURE	TAP block	ultrasound guided injection of local anesthetic in the fascial plane between the internal oblique and transversus abdominis muscles

Timeline

• Start date: 2023-01-04
• Primary completion: 2023-12-01
• Completion: 2023-12-31
• First posted: 2023-01-17
• Last updated: 2023-01-17

Locations

1 site across 1 country: Italy