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

NCT01552148 Phase 4 COMPLETED

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

Details

Lead sponsor	Istituti Ospitalieri di Cremona
Phase	Phase 4
Status	COMPLETED
Enrolment	52
Start date	2012-03
Completion	2013-03

Conditions

• Hysterectomy
• Laparoscopic Surgery

Interventions

• USguided bilateral TAP block
• Morphine Patient Controlled Analgesia
• Morphine Patient Controlled Analgesia

Primary outcomes

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

Countries

Italy