NCT01552148

Brief Summary

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:

  • 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

February 17, 2014

Status Verified

February 1, 2014

Enrollment Period

1 year

First QC Date

March 6, 2012

Last Update Submit

February 14, 2014

Conditions

HysterectomyLaparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

  • PCA morphine consumption in the two groups within the first 24 postoperative hours

    24 hours postoperatively

Secondary Outcomes (5)

  • Numerical Rating Scores for pain at rest and during movement

    24 hours postoperatively

  • Time to discharge from Recovery Room

    24 hours postoperatively

  • time to discharge from the surgical floor

    24 hours postoperatively

  • evaluation of patients' functional capacity postoperatively versus baseline

    24 hours postoperatively

  • postoperative nausea/vomiting incidence

    24 hours postoperatively

Study Arms (2)

Group TAP (US guided)

ACTIVE COMPARATOR

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 blockDrug: Morphine Patient Controlled Analgesia

Group Control

OTHER
Drug: Morphine Patient Controlled Analgesia

Interventions

USguided bilateral TAP blockOTHER

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

Group TAP (US guided)
Morphine Patient Controlled AnalgesiaDRUG

Morphine PCA i.v. (bolus 2mg, lockout 8 min)

Group TAP (US guided)

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years \< age \< 70 years
  • ASA I - II - III
  • undergoing elective laparoscopic hysterectomy
  • signed informed consent

You may not qualify if:

  • 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)
  • Kg/m2 \< BMI \< 30Kg/m2
  • alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Istituti Ospitalieri di Cremona

Cremona, CR, 26100, Italy

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Anaesthesia Department, Istituti Ospitalieri, Cremona

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 13, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

February 17, 2014

Record last verified: 2014-02

Locations

IT(1)