NCT01552148

Transversus Abdominis Plane Block for Laparoscopic Hysterectomy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Istituti Ospitalieri di Cremona · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Hysterectomy
• Laparoscopic Surgery

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-03-13
• Last updated: 2014-02-17

Locations

1 site across 1 country: Italy