Transversus Abdominis Plane Block for Laparoscopic Hysterectomy

Study Overview
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Brief Summary
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Purpose To evaluate whether adding a transversus abdominis plane block in patients undergoing elective laparoscopic hysterectomy reduces Patient-controlled analgesia (PCA) morphine requirements during the first 24 hours postoperatively. Forty-six patients undergoing laparoscopic hysterectomy will be randomized into two groups: Group treatment TAP (n=23) will receive the following analgesia: US guided transversus abdominis plane block performed with 40ml of 0.375% levobupivacaine (20 ml per side) after general anaesthesia induction, before surgical start Morphine PCA with loading dose i.v. titrated by the PACU nurse if pain > 5/10 at rest Group control will receive: Morphine PCA with loading dose i.v. titrated by the PACU nurse if pain > 5/10 at rest Primary Outcome Measures: Morphine consumption (mg) (Time Frame: 24 hours) in Groups TAP and Control Secondary Outcome Measures: Pain at rest and during movement quantified as Numerical Rating Scores (0-10) for pain when resting in bed and during cough during the first 24 hours postoperatively Time to PACU dimission, evaluated as patient's achievement of a White's score > or = 12/14 Time to home discharge, evaluated as patient's achievement of a PADDS score > or = 9 Functional patient capacity as measured before surgery and whenever a White's score > or = 12 will be reached (2minute walking test) Eventual side effects such as nausea/vomiting

Detailed Description
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After the start of the study, we had a higher drop out size than expected. We therefore added a 13% of patient to initial power calculation to compensate for drop outs. Total number of patients enrolled = 52 (46 + 6) Total number of patients who completed the study = 44

Official Title
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Randomized, Controlled, Observer-blinded Study on the Efficacy of TAP Block With 0.375% Levobupivacaine in Terms of PCA Morphine Postoperative Consumption in Patients Undergoing Laparoscopic Hysterectomy

Conditions
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Hysterectomy, Laparoscopic Surgery

Intervention / Treatment
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* Other: USguided bilateral TAP block
* Drug: Morphine Patient Controlled Analgesia
* Drug: Morphine Patient Controlled Analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years < age < 70 years ASA I - II - III undergoing elective laparoscopic hysterectomy signed informed consent Exclusion Criteria: chronic therapy with opioids/ antidepressants surgical conversion to open abdominal hysterectomy urgent/emergent surgery postoperative transfer to the intensive care unit pregnancy or breast feeding known allergy to any drug medication local skin infection epilepsy high bilirubin level (> 3mg/dl) or high hepatic enzymes levels (> 250UI) high creatinin level (> 1.4mg/dl) 18Kg/m2 < BMI < 30Kg/m2 alcohol or drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group TAP (US guided)<br>23 patients receiving bilateral US guided transversus abdominis plane block with 20ml of 0.375% levobupivacaine on each side, under general anaesthesia (TIVA), after induction and before surgical start | Other: USguided bilateral TAP block<br>* 23 patients receiving bilateral US guided transversus abdominis plane block with 20ml of 0.375% levobupivacaine on each side, under general anaesthesia (TIVA), after induction and before surgical start<br>Drug: Morphine Patient Controlled Analgesia<br>* Morphine PCA i.v. (bolus 2mg, lockout 8 min)<br>|
| Other: Group Control<br> | Drug: Morphine Patient Controlled Analgesia<br>* Morphine PCA i.v. (bolus 2mg, lockout 8min)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCA morphine consumption in the two groups within the first 24 postoperative hours |  | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scores for pain at rest and during movement |  | 24 hours postoperatively | 
| Time to discharge from Recovery Room | Time to achieve a White's score > or = 12 | 24 hours postoperatively | 
| time to discharge from the surgical floor | time to achieve a PADDS score > or = 9 | 24 hours postoperatively | 
| evaluation of patients' functional capacity postoperatively versus baseline | 2-minute walking test assessed as soon as a White's score > or = 12 has been reached or every 30minutes until patient is capable to walk | 24 hours postoperatively | 
| postoperative nausea/vomiting incidence |  | 24 hours postoperatively |