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

January 13, 2023 updated by: Fabio Costa, Campus Bio-Medico University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Rome, Italy
        • CampusBioMedico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
opioid consumption
Time Frame: Change from baseline and hours 6, 12, 24, 48
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
postoperative pain at rest
Time Frame: hours 6, 12, 24, 48
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
Time Frame: hours 6, 12, 24, 48
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)
Time Frame: hours 6, 12, 24, 48
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
Time Frame: hours 3, 12, 24, 48
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
Time Frame: hours 3, 12, 24, 48
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
Time Frame: hours 3, 12, 24, 48
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
Time Frame: hours 3, 12, 24, 48
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
Time Frame: hours 3, 12, 24, 48
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
Time Frame: hours 3, 12, 24, 48
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
Time Frame: hours 0, 6, 12, 24, 48 (days 30 for DVT)
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 Frame: hour 0
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
Time Frame: hour 0
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Campus Bio-Medico University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fabio Costa, Dr., Fondazione Policlinico Universitario Campus Biomedico di Roma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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