drugset / Trial / NCT01552148

Transversus Abdominis Plane Block for Laparoscopic Hysterectomy

NCT01552148 ↗

Phase 4 Completed 52 enrolled Istituti Ospitalieri di Cremona
RandomizedParallel-groupSingle-blindTreatment

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

Timeline

Start
2012-03
Primary completion
2013-03
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Background Morphine Other / unclassified 2 mg Intravenous

Indications

No indication recorded.