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Clinical Trial 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


Clinical Trial Description

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 ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01552148
Study type Interventional
Source Istituti Ospitalieri di Cremona
Contact
Status Completed
Phase Phase 4
Start date March 2012
Completion date March 2013

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