Analgesic Efficacy of Ultrasound-guided Transverse-abdominal Plain Blockade in Urological Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01501565
Recruitment Status : Completed
First Posted : December 29, 2011
Last Update Posted : November 16, 2012
Information provided by (Responsible Party):
Juan Francisco Mayoral Farre, Fundacio Puigvert

Brief Summary:
The purpose of this study is to compare pain level (according to numerical score)at 4, 8, 12 and 24 postoperative hours between patients under transverse abdominal plain blockade (TAP) and patients under conventional analgesia. Also the opioid consumption is assessed.

Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: Postoperative transverse abdominal plain (TAP) blockade Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Analgesic Transverse Abdominal Plain Blockade in the Multimodal Pain Management for Laparoscopic Urological Surgery. Analgesic Efficacy Assessment.
Study Start Date : December 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Arm Intervention/treatment
No Intervention: Control
Standard analgesic therapy: iv Metamizol 2 g q8h
Experimental: TAP

Transverse abdominal plain (TAP) blockade with local anesthetic: Bupivacaine chlorhydrate 0.25% adjusted by weight and type of surgery. Maximum dose: 150 mg of bupivacaine.

Two approaches are done: 1)Posterior TAP: the needle insertion point is cephalad to the iliac crest, behind the midaxillary line. The needle is inserted under ultrasound guidance in plane. Local anesthetics is deposited between the internal oblique and transversus abdominis muscles, 2)Subcostal TAP: the needle is inserted ultrasound guided perpendicularly to abdominal wall, directed parallel to the costal margin but oblique to the sagittal plane. Local anesthestic is deposited between transversus abdominis and the rectus abdominis muscles.

Procedure: Postoperative transverse abdominal plain (TAP) blockade
Bupivacaine 0.25%. Maximum 150 mg. A maximum of 75 mg bupivacaine is administered in each side (posterior and subcostal TAP) in a single puncture.
Other Name: Buivacaine: Inibsicain (R) 0.25% (INIBSA, S.A.)

Primary Outcome Measures :
  1. Pain level [ Time Frame: Change in pain from admittance to 24 hours postoperatively ]
    Pain is assessed by numerical scale (0 to 10) where 0 is no pain and 10 is the most intense pain possible. Pain will be assessed at 4, 6 , 8, 12 and 24 hours.

Secondary Outcome Measures :
  1. Analgesic consumption as a rescue therapy [ Time Frame: within 24 postoperative hours ]
    Analgesic consumption: morphine in miligrams.

  2. Incidence of postoperative nausea and vomiting (PONV) related to therapy [ Time Frame: within 24 postoperative hours ]
    Assessment of PONV incidence and antiemetic drugs consumption.

  3. Incidence of urethral/bladder spasm [ Time Frame: within 24 postoperative hours ]
    Pain due to bladder catheter.

  4. Assessment of oral intake tolerance [ Time Frame: within 24 postoperative hours ]
    Assessment at 6 postoperative hours for liquids, and solid food at 24 postoperative hours.

  5. Patient satisfaction [ Time Frame: within 24 postoperative hours ]
    Assessed by ordinal scale: Very pleased/Pleased/little pleased/little unpleased/unpleased/very unpleased

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • > 18 yrs.
  • Patients undergo laparoscopic urologic surgery
  • Physical status ASA < 3
  • Surgical procedure without complications
  • Signed informed consent

Exclusion Criteria:

  • Allergy to bupivacaine chlorhydrate
  • Patients with chronic pain treatment
  • Alcoholism
  • Decompensated hepatic disease
  • Coagulation disorders
  • BMI > 35
  • Patient involved in another clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01501565

Fundació Puigvert
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundacio Puigvert
Principal Investigator: Juan Francisco Mayoral, MD Fundació Puigvert (IUNA)

Responsible Party: Juan Francisco Mayoral Farre, Principal Investigator, Fundacio Puigvert Identifier: NCT01501565     History of Changes
Other Study ID Numbers: FP2011/01
2011-003219-53 ( EudraCT Number )
First Posted: December 29, 2011    Key Record Dates
Last Update Posted: November 16, 2012
Last Verified: November 2012

Keywords provided by Juan Francisco Mayoral Farre, Fundacio Puigvert:
Postoperative pain
Transverse abdominal blockade

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents