Transversus Abdominis Plane Block for Laparoscopic Hysterectomy

Phase 4

Completed

• Conditions: Hysterectomy; Laparoscopic Surgery
• Interventions: Other: USguided bilateral TAP block; Drug: Morphine Patient Controlled Analgesia

• Registration Number: NCT01552148
• Lead Sponsor: Istituti Ospitalieri di Cremona

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

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-03-12
• Study First Posted: 2012-03-13
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-14
• Last Update Posted: 2014-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group TAP (US guided)	Morphine Patient Controlled Analgesia	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
Group TAP (US guided)	USguided 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
Group Control	Morphine Patient Controlled Analgesia	-

Primary Outcome Measures

Name	Time	Method
PCA morphine consumption in the two groups within the first 24 postoperative hours	24 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Azienda Ospedaliera Istituti Ospitalieri di Cremona; 🇮🇹 Cremona, CR, Italy