Transversus Abdominis Plane Block for Laparoscopic Hysterectomy
NCT ID: NCT01552148
Last Updated: 2014-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
52 participants
INTERVENTIONAL
2012-03-31
2013-03-31
Brief Summary
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Forty-six patients undergoing laparoscopic hysterectomy will be randomized into two groups:
1. 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
2. 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
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Detailed Description
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Total number of patients enrolled = 52 (46 + 6) Total number of patients who completed the study = 44
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group TAP (US guided)
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
USguided bilateral TAP block
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
Morphine Patient Controlled Analgesia
Morphine PCA i.v. (bolus 2mg, lockout 8 min)
Group Control
Morphine Patient Controlled Analgesia
Morphine PCA i.v. (bolus 2mg, lockout 8min)
Interventions
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USguided bilateral TAP block
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
Morphine Patient Controlled Analgesia
Morphine PCA i.v. (bolus 2mg, lockout 8 min)
Morphine Patient Controlled Analgesia
Morphine PCA i.v. (bolus 2mg, lockout 8min)
Eligibility Criteria
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Inclusion Criteria
* ASA I - II - III
* undergoing elective laparoscopic hysterectomy
* signed informed consent
Exclusion Criteria
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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Istituti Ospitalieri di Cremona
OTHER
Responsible Party
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Giorgio Danelli
Chief of the Anaesthesia Department, Istituti Ospitalieri, Cremona
Locations
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Azienda Ospedaliera Istituti Ospitalieri di Cremona
Cremona, CR, Italy
Countries
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Other Identifiers
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5504/2012LD
Identifier Type: -
Identifier Source: org_study_id
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