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

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

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