Transversus Abdominis Plane Block for Laparoscopic Hysterectomy

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituti Ospitalieri di Cremona
• Treatments: Levobupivacaine; Morphine

Criteria

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