Postoperative PainWI-HYSTERNCT05686382
TAP Block vs CWI for Total Abdominal Hysterectomy, a RCT
A study testing Continuous Wound Infusion and TAP block in people with Postoperative Pain, run by Campus Bio-Medico University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Continuous Wound Infusion and TAP block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 4 Jan 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I - III
- laparotomic hysterectomy with Pfannenstiel incision
- signed informed consent
Who cannot join
- ASA IV
- allergy to local anesthetics or other components of multimodal analgesia
- inability to walk or eat
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Continuous Wound Infusion, TAP block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Wound InfusionProcedure or surgery
continuous local anesthetic infiltration of the wound
TAP blockProcedure or surgery
ultrasound guided injection of local anesthetic in the fascial plane between the internal oblique and transversus abdominis muscles
| Study group | Role | What they receive |
|---|---|---|
| group TAP block | Active comparator | TAP block is administered at the end of the surgery, bilaterally, with lateral approach, with 24 ml of 0,5% ropivacaine for each side Receives: Procedure: TAP block |
| group CWI | Experimental | 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 Receives: Procedure: Continuous Wound Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline and hours 6, 12, 24, 48
Secondary outcomes (12)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: hour 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start4 Jan 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Costa, Campus Bio-Medico University
- Investigators
- Fabio Costa, Dr., Principal investigator, Fondazione Policlinico Universitario Campus Biomedico di Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686382
- Sponsor's protocol ID
- 2022.178
- Acronym
- WI-HYSTER
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anestesia Generale + TAP Block vs Anestesia Generale + CWI Per Intervento di Isterectomia Totale Laparotomica. Trial Randomizzato Controllato.
- ClinicalTrials.gov ID
- NCT05686382
- Acronym / sponsor ID
- WI-HYSTER / 2022.178
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 4 Jan 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group TAP block | Active comparator | Procedure: TAP blockTAP block is administered at the end of the surgery, bilaterally, with lateral approach, with 24 ml of 0,5% ropivacaine for each side |
| group CWI | Experimental | Procedure: Continuous Wound InfusionA 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I - III
- laparotomic hysterectomy with Pfannenstiel incision
- signed informed consent
Key exclusion criteria (3 listed)
- ASA IV
- allergy to local anesthetics or other components of multimodal analgesia
- inability to walk or eat
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Wound Infusioncontinuous local anesthetic infiltration of the wound | Procedure or surgery | group CWI |
| TAP blockultrasound guided injection of local anesthetic in the fascial plane between the internal oblique and transversus abdominis muscles | Procedure or surgery | group TAP block |
Primary outcome
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
12 secondary outcomes
postoperative pain at rest
Time frame: hours 6, 12, 24, 48
postoperative pain during movements
Time frame: hours 6, 12, 24, 48
Postoperative Nausea and Vomiting (PONV)
Time frame: hours 6, 12, 24, 48
early refeeding
Time frame: hours 3, 12, 24, 48
early mobilization SIT-STAND-WALK
Time frame: hours 3, 12, 24, 48
vital parameters stability YES/NO
Time frame: hours 3, 12, 24, 48
vital parameter ( heart rate) stability YES/NO
Time frame: hours 3, 12, 24, 48
vital parameter (oxygen saturation) stability YES/NO
Time frame: hours 3, 12, 24, 48
Home dischargeable YES/NO
Time frame: hours 3, 12, 24, 48
complications
Time frame: hours 0, 6, 12, 24, 48 (days 30 for DVT)
HCP time consuming
Time frame: hour 0
Costs of all procedure
Time frame: hour 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Costa, Dr. principal investigator
Fondazione Policlinico Universitario Campus Biomedico di Roma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Wound Infusion and TAP block in people with Postoperative Pain, run by Campus Bio-Medico University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabio Costa, Dr. (3356526433 ext. +39, f.costa@policlinicocampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
opioid consumption (time frame: Change from baseline and hours 6, 12, 24, 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.