Ultrasound-guided Transverses Abdominis Plane Block in Inguinal Herniorrhaphy: Randomized Controlled Clinical Trial

NCT02299908 | Unknown Phase 4

• 1 other identifier: VIP 1691514
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Acute postoperative pain is one of the most important centers of therapeutic attention in postoperative phase of any procedure. It is a complex entity that requires a multiple intervention to be treated and, depending on the intervened surgical site, it has different approaches. Despite attempts to reduce postoperative pain by implementing management protocols, rates of pain prevalence from moderate acute to severe pain are still reported as high as 50% in the first 24 postoperative hours. Among the surgeries that report greater intensity of postoperative pain is open inguinal Herniorrhaphy. That is why several techniques have been described for the management of acute pain in this surgery postoperative, among which PAT blocking has shown to be beneficial in some studies. However, some reports question its usefulness but with the emergence of ultrasound-guided techniques for its realization, interest in this blockage has grown back. This study aims to demonstrate the utility of the PAT blocking in the management of acute pain of pre-peritoneal inguinal herniorrhaphy with mesh.

Conditions

Pain, Postoperative

Keywords

Hernia, Inguinal; Herniorrhaphy; Abdominal Wall; Analgesia; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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.

  1 hour after the suspension of anesthesia

Secondary Outcomes (5)

• Opioid Consumption 1

  1 hour after the suspension of anesthesia

• Adverse reactions 1

  1 hour after the suspension of anesthesia

• Postoperative acute pain 2

  24 hours after the suspension of anesthesia

• Adverse reactions 2

  24 hours after the suspension of anesthesia

• Opioid Consumption 2

  24 hours after the suspension of anesthesia

Study Arms (2)

TAP block with Bupivacaine at 0.25%

EXPERIMENTAL

Intervention: Injection of local anesthetics in the transverses abdominal plane

Drug: TAP block with Bupivacaine at 0.25%

Placebo saline solution

PLACEBO COMPARATOR

Placebo: Injection of saline solution in the transverses abdominal plane

Drug: Placebo saline solution

Interventions

TAP block with Bupivacaine at 0.25% DRUG

Application of 20 mL of local anesthetic bupivacaine at 0.25% in the transverse abdominis plane (TAP) under ultrasound guidance. This area (TAP) is between the anterior fascia of the transverse abdominal muscle and the posterior fascia of the internal oblique muscle, through which the thoracic nerve fibers and a portion of the first lumbar pass. This intervention will be done 10 minutes before conducting the ipsilateral inguinal herniorrhaphy in a single application.

Also known as: TAP block, Infiltration of local anesthetic, Local anesthesia in inguinal herniorrhaphy

TAP block with Bupivacaine at 0.25%

Placebo saline solution DRUG

Application of 20 mL of saline solution in the transverse abdominis plane (TAP).

Also known as: Saline solution

Placebo saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Patricia Salazar Villegas: lead

Study Sites (2)

Hospital Departamental Universitario Santa Sofía de Caldas

Manizales, Caldas Department, 170001, Colombia

Location

SES Hospital de Caldas

Manizales, Caldas Department, 170001, Colombia

Location

MeSH Terms

Conditions

Pain, Postoperative; Hernia, Inguinal; Agnosia

Interventions

Anesthesia, Local; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Oscar D Aguirre Ospina, Specialist

  Universidad de Caldas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Salazar Villegas, Mg.

CONTACT

(57) 6 8781500; patricia.salazar@ucaldas.edu.co

Juan C Gómez Salgado, Specialist

CONTACT

(57) 6 8783060; juan.gomez@ucaldas.edu.co

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master in Business Administration

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 24, 2014
• Study Start: November 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 24, 2014

Record last verified: 2014-11

Locations

CO (2)