Transversus Abdominis Plane Block for Laparoscopic Hysterectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giorgio Danelli, Istituti Ospitalieri di Cremona
ClinicalTrials.gov Identifier:
NCT01552148
First received: March 6, 2012
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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

Condition Intervention Phase
Hysterectomy
Laparoscopic Surgery
Other: USguided bilateral TAP block
Drug: Morphine Patient Controlled Analgesia
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Istituti Ospitalieri di Cremona:

Primary Outcome Measures:
  • PCA morphine consumption in the two groups within the first 24 postoperative hours [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Numerical Rating Scores for pain at rest and during movement [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
  • Time to discharge from Recovery Room [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    Time to achieve a White's score > or = 12

  • time to discharge from the surgical floor [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    time to achieve a PADDS score > or = 9

  • evaluation of patients' functional capacity postoperatively versus baseline [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: March 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Group Control Drug: Morphine Patient Controlled Analgesia
Morphine PCA i.v. (bolus 2mg, lockout 8min)

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552148

Locations
Italy
Azienda Ospedaliera Istituti Ospitalieri di Cremona
Cremona, CR, Italy, 26100
Sponsors and Collaborators
Istituti Ospitalieri di Cremona
  More Information

No publications provided

Responsible Party: Giorgio Danelli, Chief of the Anaesthesia Department, Istituti Ospitalieri, Cremona, Istituti Ospitalieri di Cremona
ClinicalTrials.gov Identifier: NCT01552148     History of Changes
Other Study ID Numbers: 5504/2012LD
Study First Received: March 6, 2012
Last Updated: February 14, 2014
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Levobupivacaine
Morphine
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014