Transversus Abdominis Plane Block for Laparoscopic Hysterectomy

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

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

Study Overview

• Status: Completed
• Conditions: Laparoscopic Surgery; Hysterectomy
• Intervention / Treatment: Other: USguided bilateral TAP block; Drug: Morphine Patient Controlled Analgesia; Drug: Morphine Patient Controlled Analgesia

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • CR
    • Cremona, CR, Italy, 26100
      • Azienda Ospedaliera Istituti Ospitalieri di Cremona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group TAP (US guided); 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	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); Drug: Morphine Patient Controlled Analgesia; Morphine PCA i.v. (bolus 2mg, lockout 8min)
Other: Group Control	Drug: Morphine Patient Controlled Analgesia; Morphine PCA i.v. (bolus 2mg, lockout 8 min); Drug: Morphine Patient Controlled Analgesia; Morphine PCA i.v. (bolus 2mg, lockout 8min)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PCA morphine consumption in the two groups within the first 24 postoperative hours	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scores for pain at rest and during movement		24 hours postoperatively
Time to discharge from Recovery Room	Time to achieve a White's score > or = 12	24 hours postoperatively
time to discharge from the surgical floor	time to achieve a PADDS score > or = 9	24 hours postoperatively
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
postoperative nausea/vomiting incidence		24 hours postoperatively

Collaborators and Investigators

• Sponsor: Istituti Ospitalieri di Cremona

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: March 6, 2012
• First Submitted That Met QC Criteria: March 12, 2012
• First Posted (Estimate): March 13, 2012

Study Record Updates

• Last Update Posted (Estimate): February 17, 2014
• Last Update Submitted That Met QC Criteria: February 14, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: 5504/2012LD