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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- PCA morphine consumption in the two groups within the first 24 postoperative hours
Study Overview
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:
- 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
- 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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
- •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
Arms & Interventions
Group TAP (US guided)
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
Intervention: USguided bilateral TAP block (Other)
Group TAP (US guided)
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
Intervention: Morphine Patient Controlled Analgesia (Drug)
Group Control
Intervention: Morphine Patient Controlled Analgesia (Drug)
Outcomes
Primary Outcomes
PCA morphine consumption in the two groups within the first 24 postoperative hours
Time Frame: 24 hours postoperatively
Secondary Outcomes
- Numerical Rating Scores for pain at rest and during movement(24 hours postoperatively)
- Time to discharge from Recovery Room(24 hours postoperatively)
- time to discharge from the surgical floor(24 hours postoperatively)
- evaluation of patients' functional capacity postoperatively versus baseline(24 hours postoperatively)
- postoperative nausea/vomiting incidence(24 hours postoperatively)
Investigators
Giorgio Danelli
Chief of the Anaesthesia Department, Istituti Ospitalieri, Cremona
Istituti Ospitalieri di Cremona