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

November 15, 2012 updated by: Juan Francisco Mayoral Farre, Fundacio Puigvert

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
141

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Fundacio Puigvert

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Buivacaine: Inibsicain (R) 0.25% (INIBSA, S.A.)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change in pain from admittance to 24 hours postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Analgesic consumption as a rescue therapy
Time Frame: within 24 postoperative hours
Analgesic consumption: morphine in miligrams.
within 24 postoperative hours
Incidence of postoperative nausea and vomiting (PONV) related to therapy
Time Frame: within 24 postoperative hours
Assessment of PONV incidence and antiemetic drugs consumption.
within 24 postoperative hours
Incidence of urethral/bladder spasm
Time Frame: within 24 postoperative hours
Pain due to bladder catheter.
within 24 postoperative hours
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.
within 24 postoperative hours
Patient satisfaction
Time Frame: within 24 postoperative hours
Assessed by ordinal scale: Very pleased/Pleased/little pleased/little unpleased/unpleased/very unpleased
within 24 postoperative hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacio Puigvert

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Juan Francisco Mayoral, MD, Fundació Puigvert (IUNA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FP2011/01
  • 2011-003219-53 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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