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Bilateral Erector Spinae Plane Block (ESPB) in Laparoscopic Cholecystectomies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04587973
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Kassiani Theodoraki, Aretaieion University Hospital

Brief Summary:
The aim of the trial is to study the efficacy of bilateral Erector Spinae Plane Block (ESPB) in managing perioperative pain in patients who undergo elective laparoscopic cholecystectomy

Condition or disease Intervention/treatment Phase
Pain, Postoperative Pain Syndrome Pain, Acute Anesthesia Cholecystectomy Erector Spinae Plane Block Procedure: Group Dexmedetomidine Procedure: Group Ropivacaine Procedure: Group Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effectiveness of Bilateral Erector Spinae Plane Block (ESPB) in Laparoscopic Cholecystectomies. A Randomized, Controlled, Double Blind, Prospective, Trial
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group Dexmedetomidine
Ropivacaine plus dexmedetomidine group - Preoperative bilateral erector spinae plane block with ropivacaine 0,375% (40 ml) plus dexmedetomidine 1 mcg/kg
Procedure: Group Dexmedetomidine
Ropivacaine plus dexmedetomidine group

Active Comparator: Group Ropivacaine
Plain ropivacaine group - Preoperative bilateral erector spinae plane block with ropivacaine 0,375% (40 ml)
Procedure: Group Ropivacaine
Plain ropivacaine group

Placebo Comparator: Group Control
Control group - Preoperative bilateral erector spinae plane block with N/S 0,9% (40 ml)
Procedure: Group Control
Control group




Primary Outcome Measures :
  1. pain score 3 hours postoperatively [ Time Frame: 3 hours after surgery ]
    pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  2. pain score 6 hours postoperatively [ Time Frame: 6 hours after surgery ]
    pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  3. pain score 12 hours postoperatively [ Time Frame: 12 hours after surgery ]
    pain score by the use of Numeric Rating Scale (NRS) 12 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  4. pain score 24 hours postoperatively [ Time Frame: 24 hours after surgery ]
    pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  5. pain score on arrival to Post-Anesthesia Care Unit (PACU) [ Time Frame: immediately postoperatively ]
    pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  6. pain score at discharge from Post-Anesthesia Care Unit (PACU), ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" [ Time Frame: immediately postoperatively ]
    pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU


Secondary Outcome Measures :
  1. morphine consumption [ Time Frame: 24 hours postoperatively ]
    morphine consumption through patient-controlled analgesia device for 24 hours postoperatively

  2. satisfaction from postoperative analgesia [ Time Frame: 24 hours postoperatively ]
    satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction

  3. mobilization time [ Time Frame: 24 hours postoperatively ]
    time at which the patient mobilizes after surgery

  4. hospitalization time [ Time Frame: 72 hours postoperatively ]
    duration of hospital stay after surgery in days

  5. intraoperative dose of remifentanil infusion (μg kg-1) [ Time Frame: intraoperatively ]
    dose of required remifentanil intraoperatively to maintain systolic arterial blood pressure within the 20% of baseline value

  6. Erector Spinae Plane Block-related complications [ Time Frame: 48 hours postoperatively ]
    block-related complications at the site of the local anesthetic injection

  7. Post Anesthesia Care Unit (PACU) duration of stay [ Time Frame: immediately postoperatively ]
    duration of patient stay at PACU



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I, II
  • Laparoscopic cholecystectomy
  • Elective surgery

Exclusion Criteria:

  • Patient refusal
  • Coagulation disorders
  • Known allergies to local anesthetics
  • Other contraindications to regional anesthesia
  • Infection or anatomic anomalies on injection site
  • Uncontrolled hypertension
  • Severe liver or kidney disease
  • Pregnancy
  • Known depression or psychiatric disorders, dementia
  • Drug or alcohol abuse
  • Inadequate command of Greek language

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): NCT04587973


Contacts
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Contact: Kassiani Theodoraki, PhD, DESA +306974634162 ktheodoraki@hotmail.com

Locations
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Greece
George Papanikolaou, General Hospital of Thessaloniki Recruiting
Thessaloníki, Greece, 57010
Contact: Freideriki Sifaki, MD       frida1sif1@gmail.com   
Sponsors and Collaborators
Aretaieion University Hospital
Investigators
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Study Chair: Kassiani Theodoraki, PhD, DESA Aretaieion University Hospital
Publications:

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Responsible Party: Dr Kassiani Theodoraki, Professor of Anesthesiology, Aretaieion University Hospital
ClinicalTrials.gov Identifier: NCT04587973    
Other Study ID Numbers: ESPB-Frida
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
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
Additional relevant MeSH terms:
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Pain, Postoperative
Acute Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Dexmedetomidine
Ropivacaine
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
Anesthetics, Local
Anesthetics