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NCT Number: NCT01552148

Transversus Abdominis Plane Block for 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

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Key information

Conditions

Hysterectomy Laparoscopic Surgery

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Azienda Ospedaliera Istituti Ospitalieri di Cremona

Cremona, CR, 26100, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

USguided bilateral TAP block

Other

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

Morphine Patient Controlled Analgesia

Drug

Morphine PCA i.v. (bolus 2mg, lockout 8 min)

Primary outcomes

  1. PCA morphine consumption in the two groups within the first 24 postoperative hours

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. Numerical Rating Scores for pain at rest and during movement

    Time frame: 24 hours postoperatively

  2. Time to discharge from Recovery Room

    Time frame: 24 hours postoperatively

    Time to achieve a White's score > or = 12

  3. time to discharge from the surgical floor

    Time frame: 24 hours postoperatively

    time to achieve a PADDS score > or = 9

  4. evaluation of patients' functional capacity postoperatively versus baseline

    Time frame: 24 hours postoperatively

    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

  5. postoperative nausea/vomiting incidence

    Time frame: 24 hours postoperatively

Sponsors and collaborators

Lead sponsor

Istituti Ospitalieri di Cremona

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 13, 2012
Registry last updated
Feb 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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