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

NCT ID: NCT01501565

Last Updated: 2012-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain

Keywords

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Postoperative pain Transverse abdominal blockade Efficacy Safety Urology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Standard analgesic therapy: iv Metamizol 2 g q8h

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Postoperative transverse abdominal plain (TAP) blockade

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacio Puigvert

OTHER

Sponsor Role lead

Responsible Party

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Juan Francisco Mayoral Farre

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan Francisco Mayoral, MD

Role: PRINCIPAL_INVESTIGATOR

Fundació Puigvert (IUNA)

Locations

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Fundació Puigvert

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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2011-003219-53

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FP2011/01

Identifier Type: -

Identifier Source: org_study_id