NCT01501565

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P75+ for phase_4 postoperative-pain

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 16, 2012

Status Verified

November 1, 2012

Enrollment Period

11 months

First QC Date

December 22, 2011

Last Update Submit

November 15, 2012

Conditions

Postoperative Pain

Keywords

Postoperative painTransverse abdominal blockadeEfficacySafetyUrology

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change in pain from admittance to 24 hours postoperatively

Secondary Outcomes (5)

  • Analgesic consumption as a rescue therapy

    within 24 postoperative hours

  • Incidence of postoperative nausea and vomiting (PONV) related to therapy

    within 24 postoperative hours

  • Incidence of urethral/bladder spasm

    within 24 postoperative hours

  • Assessment of oral intake tolerance

    within 24 postoperative hours

  • Patient satisfaction

    within 24 postoperative hours

Study Arms (2)

Control

NO INTERVENTION

Standard analgesic therapy: iv Metamizol 2 g q8h

TAP

EXPERIMENTAL

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

Interventions

Postoperative transverse abdominal plain (TAP) blockadePROCEDURE

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.

Also known as: Buivacaine: Inibsicain (R) 0.25% (INIBSA, S.A.)
TAP

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 yrs.
  • Patients undergo laparoscopic urologic surgery
  • Physical status ASA \< 3
  • Surgical procedure without complications
  • Signed informed consent

You may not qualify if:

  • Allergy to bupivacaine chlorhydrate
  • Patients with chronic pain treatment
  • Alcoholism
  • Decompensated hepatic disease
  • Coagulation disorders
  • BMI \> 35
  • Patient involved in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundació Puigvert

Barcelona, Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Juan Francisco Mayoral, MD

    Fundació Puigvert (IUNA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2011

First Posted

December 29, 2011

Study Start

December 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 16, 2012

Record last verified: 2012-11

Locations

ES(1)