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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Postoperative transverse abdominal plain (TAP) blockade
Sponsored by
Fundacio Puigvert
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, Transverse abdominal blockade, Efficacy, Safety, Urology

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fundació Puigvert

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

TAP

Arm Description

Standard analgesic therapy: iv Metamizol 2 g q8h

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.

Outcomes

Primary Outcome Measures

Pain level
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
Analgesic consumption: morphine in miligrams.
Incidence of postoperative nausea and vomiting (PONV) related to therapy
Assessment of PONV incidence and antiemetic drugs consumption.
Incidence of urethral/bladder spasm
Pain due to bladder catheter.
Assessment of oral intake tolerance
Assessment at 6 postoperative hours for liquids, and solid food at 24 postoperative hours.
Patient satisfaction
Assessed by ordinal scale: Very pleased/Pleased/little pleased/little unpleased/unpleased/very unpleased

Full Information

First Posted
December 22, 2011
Last Updated
November 15, 2012
Sponsor
Fundacio Puigvert
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1. Study Identification

Unique Protocol Identification Number
NCT01501565
Brief Title
Analgesic Efficacy of Ultrasound-guided Transverse-abdominal Plain Blockade in Urological Surgery
Official Title
Ultrasound-guided Analgesic Transverse Abdominal Plain Blockade in the Multimodal Pain Management for Laparoscopic Urological Surgery. Analgesic Efficacy Assessment.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacio Puigvert

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative pain, Transverse abdominal blockade, Efficacy, Safety, Urology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard analgesic therapy: iv Metamizol 2 g q8h
Arm Title
TAP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Postoperative transverse abdominal plain (TAP) blockade
Other Intervention Name(s)
Buivacaine: Inibsicain (R) 0.25% (INIBSA, S.A.)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain level
Description
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.
Time Frame
Change in pain from admittance to 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Analgesic consumption as a rescue therapy
Description
Analgesic consumption: morphine in miligrams.
Time Frame
within 24 postoperative hours
Title
Incidence of postoperative nausea and vomiting (PONV) related to therapy
Description
Assessment of PONV incidence and antiemetic drugs consumption.
Time Frame
within 24 postoperative hours
Title
Incidence of urethral/bladder spasm
Description
Pain due to bladder catheter.
Time Frame
within 24 postoperative hours
Title
Assessment of oral intake tolerance
Description
Assessment at 6 postoperative hours for liquids, and solid food at 24 postoperative hours.
Time Frame
within 24 postoperative hours
Title
Patient satisfaction
Description
Assessed by ordinal scale: Very pleased/Pleased/little pleased/little unpleased/unpleased/very unpleased
Time Frame
within 24 postoperative hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Francisco Mayoral, MD
Organizational Affiliation
Fundació Puigvert (IUNA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundació Puigvert
City
Barcelona
ZIP/Postal Code
08025
Country
Spain

12. IPD Sharing Statement

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

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