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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02299908 |
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Date of registration:
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17/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Ultrasound-guided Transverses Abdominis Plane Block in Inguinal Herniorrhaphy: Randomized Controlled Clinical Trial
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Scientific title:
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Ultrasound-guided Transverses Abdominis Plane Block in Inguinal Herniorrhaphy: Randomized Controlled Clinical Trial |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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40 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02299908 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Colombia
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Contacts
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Name:
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Oscar D Aguirre Ospina, Specialist |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidad de Caldas |
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Name:
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Patricia Salazar Villegas, Mg. |
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Address:
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Telephone:
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(57) 6 8781500 |
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Email:
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patricia.salazar@ucaldas.edu.co |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients over 18 years attending Servicios Especiales de Salud (SES) Hospital of
Caldas and Santa Sofia Hospital for inguinal hernia surgery.
- Physical status classification of the American Society of Anesthesiologists (ASA)
(ASA I: healthy patient with no history or comorbidity and ASA II patients with
compensated systemic disease).
- Acceptance to complete the informed consent.
Exclusion Criteria:
- Bilateral inguinal hernia.
- Allergy to drugs used in the study protocol (propofol, remifentanil, dipyrone,
Dexamethasone, Tramadol, Morphine, Bupivacaine, Cephalexin, Cefazolin, Lidocaine,
Sevoflurane, Chlorhexidine, Adrenaline, Naproxen, Acetaminophen)
- Lack of communication with the patient
- Inadequate social support network and interaction with the physician.
- Spinal Anesthesia
- Herniorrhaphy without mesh.
- Pregnancy
- Abuse of psychoactive substances.
- Daily consumption of opioids.
- Consumption of analgesics during the last 24 hours prior to surgery.
- Infection at the incision site
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pain, Postoperative
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Intervention(s)
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Drug: Placebo saline solution
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Drug: TAP block with Bupivacaine at 0.25%
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Primary Outcome(s)
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Postoperative acute pain measured by the visual analog scale (VAS) from 1-10 with 1 being the lowest and 10 the highest intensity after one hour of anesthesia suspension.
[Time Frame: 1 hour after the suspension of anesthesia]
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Secondary Outcome(s)
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Adverse reactions 1
[Time Frame: 1 hour after the suspension of anesthesia]
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Opioid Consumption 1
[Time Frame: 1 hour after the suspension of anesthesia]
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Adverse reactions 2
[Time Frame: 24 hours after the suspension of anesthesia]
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Postoperative acute pain 2
[Time Frame: 24 hours after the suspension of anesthesia]
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Opioid Consumption 2
[Time Frame: 24 hours after the suspension of anesthesia]
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Secondary ID(s)
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VIP 1691514
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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