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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: TAP block; Procedure: Continuous Wound Infusion

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.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabio Costa, Dr.; Phone Number: +39 3356526433; Email: f.costa@policlinicocampus.it

Study Locations

• Italy
  • Rome, Italy
    • CampusBioMedico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: TAP block; ultrasound guided injection of local anesthetic in the fascial plane between the internal oblique and transversus abdominis muscles
Experimental: 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	Procedure: Continuous Wound Infusion; continuous local anesthetic infiltration of the wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid consumption	morphine equivalents requested (patients request oxycodone 5 mg (7,5 mg morphine equivalents) each time they experience pain at intensity higher than 4 in the NRS scale	Change from baseline and hours 6, 12, 24, 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain at rest	pain at rest (numeric rating scale NRS). The patient is asked to represent her pain with a number from 0 to 10 where 0 means absence of pain and 10 means the worst pain possible	hours 6, 12, 24, 48
postoperative pain during movements	pain at movement (numeric rating scale NRS). The patient is asked to change her position from lying to seating and represent the pain evoked by that movement with a number from 0 to 10 where 0 means absence of pain and 10 means the worst pain possible	hours 6, 12, 24, 48
Postoperative Nausea and Vomiting (PONV)	This outcome measure would reflect a reduction in opioid consumption. One episode of PONV is registered If the patient experienced either nausea or vomiting in the specified time frame. Single episodes for any time frame and the overall number of episodes in the 48 hours are registered	hours 6, 12, 24, 48
early refeeding	ability to drink and eat. This outcome measure would reflect a reduction in opioid consumption. The patient is asked to drink a glass of water in the specified time frame. After 10 minutes, if no nausea is experienced, the patient is asked to eat a light biscuit or similar. If tolerated, a "YES" is recorded in the specified time frame and in the subsequent ones refeeding is not investigated	hours 3, 12, 24, 48
early mobilization SIT-STAND-WALK	Early mobilization: ability to sit, stand and walk. This outcome measure would reflect a reduction in opioid consumption and the stability of vital parameters. At the specified time frame the patient is asked to assume the sitting position. If the position change is not hampered by pain or dizziness, she is asked to stand. If the patient could stand for 10 seconds is asked to walk for 10 steps. In each time frame is recorded the kind of mobilization obtained (sit; stand; walk). After obtaining a "walk", mobility in subsequent time frames is not investigated	hours 3, 12, 24, 48
vital parameters stability YES/NO	Mean blood pressure is measured in each time frame and compared with the baseline preoperative data. If they were found similar a "YES" is recorded. A difference from baseline > 20%. is considered to reflect poor stability and a "NO" is recorded.	hours 3, 12, 24, 48
vital parameter ( heart rate) stability YES/NO	heart rate is measured in each time frame and compared with the baseline preoperative data. If they were found similar a "YES" is recorded. A difference from baseline > 20%. is considered to reflect poor stability and a "NO" is recorded.	hours 3, 12, 24, 48
vital parameter (oxygen saturation) stability YES/NO	oxygen saturation are measured in each time frame and compared with the baseline preoperative data. If they were found similar a "YES" is recorded. A difference from baseline > 20%. is considered to reflect poor stability and a "NO" is recorded.	hours 3, 12, 24, 48
Home dischargeable YES/NO	Check list for possible discharge: This outcome measure would investigate the potential for an early discharge, taking into account all the previously collected data. A check list reassuming all the outcomes will help to obtain a "YES" or a "NO" in each time frame. After obtaining a "YES", dischargeability in subsequent time frames is not investigated Check list for possible discharge: This outcome measure would investigate the potential for an early discharge, taking into account all the previously collected data. A check list reassuming all the outcomes will help to obtain a "YES" or a "NO" in each time frame. After obtaining a "YES", dischargeability in subsequent time frames is not investigated	hours 3, 12, 24, 48
complications	any other possible complication is registered as description (catheter dislocation, hematoma in the TAP site, leakage from the catheter exit site, etc.) in a note in each time frame. At 30 days postoperatively, through phone interview, the patient is investigated for possible deep vein thrombosis diagnosis.	hours 0, 6, 12, 24, 48 (days 30 for DVT)
HCP time consuming	time needed to deliver TAP block or CWI. For each patient the time necessary to insert the catheter or to perform the TAP block is recorded	hour 0
Costs of all procedure	difference in costs between groups. Costs of all procedure related costs are taken into account (drugs, devices, HCP time, OR time) and compared	hour 0

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University
• Investigators: Principal Investigator: Fabio Costa, Dr., Fondazione Policlinico Universitario Campus Biomedico di Roma

Study record dates

Study Major Dates

• Study Start (Anticipated): January 4, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 2, 2023
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Estimate): January 16, 2023

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2022.178

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No