Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Group treatment TAP (n=23) will receive the following analgesia:
Group control will receive:
Primary Outcome Measures:
Morphine consumption (mg) (Time Frame: 24 hours) in Groups TAP and Control
Secondary Outcome Measures:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group TAP (US guided) | Active Comparator | 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 |
|
| Group Control | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| USguided bilateral TAP block | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PCA morphine consumption in the two groups within the first 24 postoperative hours | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scores for pain at rest and during movement | 24 hours postoperatively | |
| Time to discharge from Recovery Room | Time to achieve a White's score > or = 12 | 24 hours postoperatively |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Istituti Ospitalieri di Cremona | Cremona | CR | 26100 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
| Morphine Patient Controlled Analgesia | Drug | Morphine PCA i.v. (bolus 2mg, lockout 8 min) |
|
| Morphine Patient Controlled Analgesia | Drug | Morphine PCA i.v. (bolus 2mg, lockout 8min) |
|
| time to discharge from the surgical floor | time to achieve a PADDS score > or = 9 | 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 | 24 hours postoperatively |
| postoperative nausea/vomiting incidence | 24 hours postoperatively |