Hysterectomy, Laparoscopic Surgery
Conditions
Brief 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
Interventions
OTHERUSguided 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
Morphine PCA i.v. (bolus 2mg, lockout 8 min)
Sponsors
Istituti Ospitalieri di Cremona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 18 years \< age \< 70 years * ASA I - II - III * undergoing elective laparoscopic hysterectomy * signed informed consent
Exclusion criteria
* chronic therapy with opioids/ antidepressants * surgical conversion to open abdominal hysterectomy * urgent/emergent surgery * postoperative transfer to the intensive care unit * pregnancy or breast feeding * known allergy to any drug medication * local skin infection * epilepsy * high bilirubin level (\> 3mg/dl) or high hepatic enzymes levels (\> 250UI) * high creatinin level (\> 1.4mg/dl) * 18Kg/m2 \< BMI \< 30Kg/m2 * alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCA morphine consumption in the two groups within the first 24 postoperative hours | 24 hours postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scores for pain at rest and during movement | 24 hours postoperatively | — |
| Time to discharge from Recovery Room | 24 hours postoperatively | Time to achieve a White's score \> or = 12 |
| time to discharge from the surgical floor | 24 hours postoperatively | time to achieve a PADDS score \> or = 9 |
| evaluation of patients' functional capacity postoperatively versus baseline | 24 hours postoperatively | 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 |
| postoperative nausea/vomiting incidence | 24 hours postoperatively | — |
Countries
Italy
Outcome results
None listed