Transversus Abdominis Plane Block for Laparoscopic Hysterectomy

Istituti Ospitalieri di Cremona

Status and phase: Completed; Phase 4

Conditions: Laparoscopic Surgery; Hysterectomy

Treatments: Other: USguided bilateral TAP block; Drug: Morphine Patient Controlled Analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT01552148

5504/2012LD

Details and patient eligibility

About

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

Full 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

Enrollment: 52 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Group TAP (US guided)

Active Comparator group

Description:

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

Treatment:

Drug: Morphine Patient Controlled Analgesia

Other: USguided bilateral TAP block

Drug: Morphine Patient Controlled Analgesia

Group Control

Other group

Treatment:

Drug: Morphine Patient Controlled Analgesia

Drug: Morphine Patient Controlled Analgesia