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Completed

NCT Number: NCT01501565

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fundació Puigvert

Barcelona, 08025, Spain

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Postoperative transverse abdominal plain (TAP) blockade

Procedure

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 names: Buivacaine: Inibsicain (R) 0.25% (INIBSA, S.A.)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fundacio Puigvert

Other

Registry information

Official study title

Ultrasound-guided Analgesic Transverse Abdominal Plain Blockade in the Multimodal Pain Management for Laparoscopic Urological Surgery. Analgesic Efficacy Assessment.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 29, 2011
Registry last updated
Nov 16, 2012

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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