Clinical trial NCT01552148: Transversus Abdominis Plane Block for Laparoscopic Hysterectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hysterectomy
Laparoscopic Surgery
Lead sponsor: Istituti Ospitalieri di Cremona
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: PCA morphine consumption in the two groups within the first 24 postoperative hours
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Numerical Rating Scores for pain at rest and during movement
timeFrame: 24 hours postoperatively
measure: Time to discharge from Recovery Room
timeFrame: 24 hours postoperatively
measure: time to discharge from the surgical floor
timeFrame: 24 hours postoperatively
measure: evaluation of patients' functional capacity postoperatively versus baseline
timeFrame: 24 hours postoperatively
measure: postoperative nausea/vomiting incidence
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Cremona
country: Italy
facility: Azienda Ospedaliera Istituti Ospitalieri di Cremona
state: CR
Study officials:
References: