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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Juan Francisco Mayoral Farre, Fundacio Puigvert
ClinicalTrials.gov Identifier:
NCT01501565
First received: December 22, 2011
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Postoperative Pain
 Procedure: Postoperative transverse abdominal plain (TAP) blockade
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fundacio Puigvert:

Primary Outcome Measures:
  • Pain level [ Time Frame: Change in pain from admittance to 24 hours postoperatively ] [ Designated as safety issue: No ]
    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:
  • Analgesic consumption as a rescue therapy [ Time Frame: within 24 postoperative hours ] [ Designated as safety issue: Yes ]
    Analgesic consumption: morphine in miligrams.

  • Incidence of postoperative nausea and vomiting (PONV) related to therapy [ Time Frame: within 24 postoperative hours ] [ Designated as safety issue: Yes ]
    Assessment of PONV incidence and antiemetic drugs consumption.

  • Incidence of urethral/bladder spasm [ Time Frame: within 24 postoperative hours ] [ Designated as safety issue: Yes ]
    Pain due to bladder catheter.

  • Assessment of oral intake tolerance [ Time Frame: within 24 postoperative hours ] [ Designated as safety issue: Yes ]
    Assessment at 6 postoperative hours for liquids, and solid food at 24 postoperative hours.

  • Patient satisfaction [ Time Frame: within 24 postoperative hours ] [ Designated as safety issue: No ]
    Assessed by ordinal scale: Very pleased/Pleased/little pleased/little unpleased/unpleased/very unpleased


Enrollment: 141
Study Start Date: December 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501565

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

No publications provided

Responsible Party: Juan Francisco Mayoral Farre, Principal Investigator, Fundacio Puigvert
ClinicalTrials.gov Identifier: NCT01501565     History of Changes
Other Study ID Numbers: FP2011/01, 2011-003219-53
Study First Received: December 22, 2011
Last Updated: November 15, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Fundacio Puigvert:
Postoperative pain
Transverse abdominal blockade
Efficacy
Safety
Urology

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013