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Transversus Abdominis Plane Block for Laparoscopic Hysterectomy

NCT01552148 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2014-02-17

No results posted yet for this study

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:

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

Conditions

  • Hysterectomy
  • Laparoscopic Surgery

Interventions

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)

Sponsors & Collaborators

  • Istituti Ospitalieri di Cremona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01552148 on ClinicalTrials.gov