TAP Block vs CWI for Total Abdominal Hysterectomy, a RCT

NCT ID: NCT05686382

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-04
• Study Completion Date: 2023-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group TAP block

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

Group Type: ACTIVE_COMPARATOR

TAP block

Intervention Type: PROCEDURE

ultrasound guided injection of local anesthetic in the fascial plane between the internal oblique and transversus abdominis muscles

group CWI

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

Group Type: EXPERIMENTAL

Continuous Wound Infusion

Intervention Type: PROCEDURE

continuous local anesthetic infiltration of the wound

Interventions

Continuous Wound Infusion

continuous local anesthetic infiltration of the wound

Intervention Type: PROCEDURE

TAP block

ultrasound guided injection of local anesthetic in the fascial plane between the internal oblique and transversus abdominis muscles

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Campus Bio-Medico University

OTHER

Sponsor Role: lead

Responsible Party

Fabio Costa

Consultant Department of Anesthesia - Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fabio Costa, Dr.

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Campus Biomedico di Roma

Locations

CampusBioMedico

Rome, , Italy

Countries

Italy

Central Contacts

Fabio Costa, Dr.

Role: CONTACT

f.costa@policlinicocampus.it

3356526433 ext. +39

Other Identifiers

2022.178

Identifier Type: -

Identifier Source: org_study_id