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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01552148
Other study ID # 5504/2012LD
Secondary ID
Status Completed
Phase Phase 4
First received March 6, 2012
Last updated February 14, 2014
Start date March 2012
Est. completion date March 2013

Study information

Verified date February 2014
Source Istituti Ospitalieri di Cremona
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
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
Drug:
Morphine Patient Controlled Analgesia
Morphine PCA i.v. (bolus 2mg, lockout 8 min)
Morphine Patient Controlled Analgesia
Morphine PCA i.v. (bolus 2mg, lockout 8min)

Locations

Country Name City State
Italy Azienda Ospedaliera Istituti Ospitalieri di Cremona Cremona CR

Sponsors (1)

Lead Sponsor Collaborator
Istituti Ospitalieri di Cremona

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary PCA morphine consumption in the two groups within the first 24 postoperative hours 24 hours postoperatively No
Secondary Numerical Rating Scores for pain at rest and during movement 24 hours postoperatively No
Secondary Time to discharge from Recovery Room Time to achieve a White's score > or = 12 24 hours postoperatively No
Secondary time to discharge from the surgical floor time to achieve a PADDS score > or = 9 24 hours postoperatively No
Secondary evaluation of patients' functional capacity postoperatively versus baseline 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 24 hours postoperatively No
Secondary postoperative nausea/vomiting incidence 24 hours postoperatively Yes
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