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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
52
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
Morphine PCA i.v. (bolus 2mg, lockout 8 min)
Morphine PCA i.v. (bolus 2mg, lockout 8min)
Azienda Ospedaliera Istituti Ospitalieri di Cremona
Cremona, CR, Italy
PCA morphine consumption in the two groups within the first 24 postoperative hours
Time frame: 24 hours postoperatively
Numerical Rating Scores for pain at rest and during movement
Time frame: 24 hours postoperatively
Time to discharge from Recovery Room
Time to achieve a White's score \> or = 12
Time frame: 24 hours postoperatively
time to discharge from the surgical floor
time to achieve a PADDS score \> or = 9
Time frame: 24 hours postoperatively
evaluation of patients' functional capacity postoperatively versus baseline
2-minute walking test assessed as soon as a White's score \> or = 12 has been reached or every 30minutes until patient is capable to walk
Time frame: 24 hours postoperatively
postoperative nausea/vomiting incidence
Time frame: 24 hours postoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.