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Transversus Abdominis Plane Block for Laparoscopic Hysterectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giorgio Danelli, Istituti Ospitalieri di Cremona
ClinicalTrials.gov Identifier:
NCT01552148
First received: March 6, 2012
Last updated: February 14, 2014
Last verified: February 2014

March 6, 2012
February 14, 2014
March 2012
March 2013   (final data collection date for primary outcome measure)
PCA morphine consumption in the two groups within the first 24 postoperative hours [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01552148 on ClinicalTrials.gov Archive Site
  • Numerical Rating Scores for pain at rest and during movement [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
  • Time to discharge from Recovery Room [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    Time to achieve a White's score > or = 12
  • time to discharge from the surgical floor [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    time to achieve a PADDS score > or = 9
  • evaluation of patients' functional capacity postoperatively versus baseline [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    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
  • postoperative nausea/vomiting incidence [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Transversus Abdominis Plane Block for Laparoscopic Hysterectomy
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

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:

  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

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Hysterectomy
  • Laparoscopic Surgery
  • Other: 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
  • Drug: Morphine Patient Controlled Analgesia
    Morphine PCA i.v. (bolus 2mg, lockout 8 min)
  • Drug: Morphine Patient Controlled Analgesia
    Morphine PCA i.v. (bolus 2mg, lockout 8min)
  • Active Comparator: 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
    Interventions:
    • Other: USguided bilateral TAP block
    • Drug: Morphine Patient Controlled Analgesia
  • Group Control
    Intervention: Drug: Morphine Patient Controlled Analgesia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01552148
5504/2012LD
Not Provided
Giorgio Danelli, Istituti Ospitalieri di Cremona
Istituti Ospitalieri di Cremona
Not Provided
Not Provided
Istituti Ospitalieri di Cremona
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP