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

Primary Purpose

Postoperative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Continuous Wound Infusion
TAP block
Sponsored by
Campus Bio-Medico University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • CampusBioMedico

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

group TAP block

group CWI

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
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.
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.
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.
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
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.
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
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

Full Information

First Posted
January 2, 2023
Last Updated
January 13, 2023
Sponsor
Campus Bio-Medico University
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1. Study Identification

Unique Protocol Identification Number
NCT05686382
Brief Title
TAP Block vs CWI for Total Abdominal Hysterectomy, a RCT
Acronym
WI-HYSTER
Official Title
Anestesia Generale + TAP Block vs Anestesia Generale + CWI Per Intervento di Isterectomia Totale Laparotomica. Trial Randomizzato Controllato.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 4, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group TAP block
Arm Type
Active Comparator
Arm 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
Arm Title
group CWI
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Continuous Wound Infusion
Intervention Description
continuous local anesthetic infiltration of the wound
Intervention Type
Procedure
Intervention Name(s)
TAP block
Intervention Description
ultrasound guided injection of local anesthetic in the fascial plane between the internal oblique and transversus abdominis muscles
Primary Outcome Measure Information:
Title
opioid consumption
Description
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
Time Frame
Change from baseline and hours 6, 12, 24, 48
Secondary Outcome Measure Information:
Title
postoperative pain at rest
Description
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
Time Frame
hours 6, 12, 24, 48
Title
postoperative pain during movements
Description
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
Time Frame
hours 6, 12, 24, 48
Title
Postoperative Nausea and Vomiting (PONV)
Description
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
Time Frame
hours 6, 12, 24, 48
Title
early refeeding
Description
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
Time Frame
hours 3, 12, 24, 48
Title
early mobilization SIT-STAND-WALK
Description
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
Time Frame
hours 3, 12, 24, 48
Title
vital parameters stability YES/NO
Description
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.
Time Frame
hours 3, 12, 24, 48
Title
vital parameter ( heart rate) stability YES/NO
Description
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.
Time Frame
hours 3, 12, 24, 48
Title
vital parameter (oxygen saturation) stability YES/NO
Description
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.
Time Frame
hours 3, 12, 24, 48
Title
Home dischargeable YES/NO
Description
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
Time Frame
hours 3, 12, 24, 48
Title
complications
Description
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.
Time Frame
hours 0, 6, 12, 24, 48 (days 30 for DVT)
Title
HCP time consuming
Description
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
Time Frame
hour 0
Title
Costs of all procedure
Description
difference in costs between groups. Costs of all procedure related costs are taken into account (drugs, devices, HCP time, OR time) and compared
Time Frame
hour 0

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabio Costa, Dr.
Phone
3356526433
Ext
+39
Email
f.costa@policlinicocampus.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio Costa, Dr.
Organizational Affiliation
Fondazione Policlinico Universitario Campus Biomedico di Roma
Official's Role
Principal Investigator
Facility Information:
Facility Name
CampusBioMedico
City
Rome
Country
Italy

12. IPD Sharing Statement

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TAP Block vs CWI for Total Abdominal Hysterectomy, a RCT

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