Transversus Abdominis Plane Block for Laparoscopic Hysterectomy

Hysterectomy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552148
• Other study ID #: 5504/2012LD
• 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

• Hysterectomy
• Laparoscopic Surgery

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