TAP Block vs CWI for Total Abdominal Hysterectomy, a RCT (WI-HYSTER)

Campus Bio-Medico University of Rome

Status: Not yet enrolling

Conditions: Postoperative Pain

Treatments: Procedure: Continuous Wound Infusion; Procedure: TAP block

Study type: Interventional

Funder types: Other

Identifiers

NCT05686382

2022.178

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA I - III
• laparotomic hysterectomy with Pfannenstiel incision
• signed informed consent

Exclusion criteria

• ASA IV
• allergy to local anesthetics or other components of multimodal analgesia
• inability to walk or eat

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

group TAP block

Active Comparator group

Description:

TAP block is administered at the end of the surgery, bilaterally, with lateral approach, with 24 ml of 0,5% ropivacaine for each side

Treatment:

Procedure: TAP block

group CWI

Experimental group

Description:

A 15 cm long, multihole catheter is placed on the preperitoneal plane before fascia closure; a starting bolus of 10 ml of 0,5% ropivacaine is administered through the catheter, then a continuous infusion of 0,2% ropivacaine at a rate of 5 ml/h is started through a pump and continued for 48 hours

Treatment:

Procedure: Continuous Wound Infusion