TAP Block vs CWI for Total Abdominal Hysterectomy, a RCT

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Continuous Wound Infusion
* Procedure: TAP block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group TAP block<br>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<br>* ultrasound guided injection of local anesthetic in the fascial plane between the internal oblique and transversus abdominis muscles<br>|
| Experimental: group CWI<br>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<br>* continuous local anesthetic infiltration of the wound<br>|

What is the study measuring?
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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 |