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Trial record 49 of 326 for:    clonidine

Dexmedetomidine Versus Clonidine in TAP Block

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ClinicalTrials.gov Identifier: NCT03155646
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
RAGAA AHMED HERDAN, Assiut University

Brief Summary:

A laparoscopic approach offers several advantages over an open procedures; potentially reduces the surgical stress and fluid shifts that may accompany it; in addition there is less need for postoperative analgesia, reduction of postoperative respiratory and wound complications.

Despite the minimally invasive nature, pain can be moderate to severe in the immediate postoperative period that requires multimodal analgesia. Inadequate control of post-operative pain leads to several unwanted adverse events ranging from patients' discomfort and prolonged immobilization to thromboembolic phenomenon and pulmonary complications.

Transversus abdominis plane (TAP) block is a type of peripheral nerve block that involves innervation of the anterolateral abdominal wall. With the aid of ultrasound, local anesthetic (LA) is injected into the transversus abdominis fascial plane, where the nerves from T6 to L1 are located.

Ultrasound TAP block is accompanied by a good pain relief and reduced intraoperative and postoperative opioids requirements after laparoscopic surgery. In this case a bilateral TAP block is necessary because the abdominal skin incisions for the ports of laparoscopic procedure are performed on both sides.

Unfortunately, TAP block duration is limited to the effect of administered LA. Recently, adjuvant medications were added to LA to prolong the effect of TAP block. Dexmedetomidine is a selective alpha 2 (α2) adrenergic agonist with both analgesic and sedative properties. Its use with bupivacaine either epidurally or intrathecally is associated with prolongation of the LA effect. A major advantage of dexmedetomidine is its higher selectivity compared with clonidine for α2A receptors, responsible for the hypnotic and analgesic effects of such drugs.10 Clonidine action, similar to local anesthetic action, and its interaction with local anesthetics have been explained by three possible mechanisms. First, clonidine blocks Ad and C fibers. Secondly, clonidine may cause local vasoconstriction, thus decreasing local anesthetic spread and removal around neural structures. Thirdly, clonidine used in peripheral blocks intensifies and prolongs analgesia.


Condition or disease Intervention/treatment Phase
Transversus Abdominis Plane Block Drug: Dexmedetomidine Drug: Clonidine Drug: Levobupivacaine Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dexmedetomidine Versus Clonidine Adjuvants to Levobupivacaine for Transversus Abdominis Plane Block in Pediatric Laparoscopic Orcheopexy: Randomized Double-blind Study
Actual Study Start Date : June 10, 2017
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 1, 2018

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Arm Intervention/treatment
Active Comparator: DEXMEDETOMIDINE
patients will receive ultrasound-guided TAP block using 0.3 ml/kg levobupivacaine (0.125%) with a maximum volume of 20 ml each side + 0.5 ug/kg dexmedetomidine Hydrochloride dissolved in 2 ml normal saline (NaCl 0.9%).
Drug: Dexmedetomidine
patients will receive ultrasound-guided TAP block using 0.3 ml/kg levobupivacaine (0.125%) with a maximum volume of 20 ml each side + 0.5 ug/kg dexmedetomidine Hydrochloride dissolved in 2 ml normal saline (NaCl 0.9%)

Active Comparator: CLONIDINE
patients will receive ultrasound-guided TAP block using 0.3 ml/kg levobupivacaine (0.125%) with a maximum volume of 20 ml + 0.5 ug/kg clonidine dissolved in 2 ml normal saline (NaCl 0.9%).
Drug: Clonidine
patients will receive ultrasound-guided TAP block using 0.3 ml/kg levobupivacaine (0.125%) with a maximum volume of 20 ml + 0.5 ug/kg clonidine dissolved in 2 ml normal saline (NaCl 0.9%)

Active Comparator: LEVOBUPIVACAINE
patients will receive ultrasound-guided TAP block using 0.3 ml/kg levobupivacaine (0.125%) with a maximum volume of 20 ml + 2 ml normal saline (NaCl 0.9%).
Drug: Levobupivacaine
patients will receive ultrasound-guided TAP block using 0.3 ml/kg levobupivacaine (0.125%) with a maximum volume of 20 ml + 2 ml normal saline (NaCl 0.9%).
Other Name: Control




Primary Outcome Measures :
  1. modified CHEOPS [ Time Frame: 24 hours ]
    postoperative pain assessment score in children


Secondary Outcome Measures :
  1. sedation score [ Time Frame: 24 hours ]
    postoperative sedation in children

  2. 5-point Likert scale [ Time Frame: 24 hours ]
    parent satisfaction score postoperatively

  3. complications [ Time Frame: 24 hours ]
    postoperative complications will be recorded and treated



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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II physical status patients.
  • Age between 3 and 8 years.
  • Children undergoing laparoscopic orcheopexy.

Exclusion Criteria:

  • Parent refusal
  • History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult
  • Hypersensitivity to any local anesthetics
  • Bleeding diathesis
  • History of renal, hepatic, cardiac, upper or lower airway or neurological diseases
  • Any sign of infection at the puncture site of the proposed block
  • History of sleep apnea with which postoperative ventilation may be required

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155646


Locations
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Egypt
Assiut University Hospital
Assiut, Egypt
Sponsors and Collaborators
Assiut University

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Responsible Party: RAGAA AHMED HERDAN, Lecturer of Anesthesia and Intensive Care, Assiut University
ClinicalTrials.gov Identifier: NCT03155646     History of Changes
Other Study ID Numbers: TAP block
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by RAGAA AHMED HERDAN, Assiut University:
TAP block
Dexmedetomidine
Clonidine
Additional relevant MeSH terms:
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Clonidine
Dexmedetomidine
Levobupivacaine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Anesthetics, Local
Anesthetics