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Bilateral vs. Unilateral Erector Spinae Plane Block

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03781687
Recruitment Status : Completed
First Posted : December 20, 2018
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
Can AKSU, Kocaeli University

Study Description
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Brief Summary:
The importance of multimodal analgesia for postoperative pain management is well known and regional anesthesia techniques are commonly prefferred to provide better analgesia. Erector spinae plane block (ESB) is a new defined and effective regional anesthesia technique. But two injections can be unconfortable for some patients. With this study, we aimed to compare the analgesia effect of bilateral and unilateral ESP block for laparoscopic cholecystectomy.

Condition or disease Intervention/treatment Phase
Postoperative Pain Cholecystitis; Gallstone Procedure: Bilateral ESP Block Procedure: Unilateral ESP Block Device: Intravenous Morphine patient controlled analgesia device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Bilateral vs. Unilateral Erector Spinae Plane Block for Laparoscopic Cholecystectomy; A Randomised Controlled Trial
Actual Study Start Date : January 2, 2019
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 29, 2019

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Bilateral
Bilateral ESP block will be performed
 Procedure: Bilateral ESP Block
Bilateral ESP Block will be performed at T8

Device: Intravenous Morphine patient controlled analgesia device
24 hour morphine consumption will be recorded
Active Comparator: Unilateral
Unilateral ESP block will be performed
 Procedure: Unilateral ESP Block
Unilateral ESP Block will be performed at T8 (right side)

Device: Intravenous Morphine patient controlled analgesia device
24 hour morphine consumption will be recorded


Outcome Measures
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Primary Outcome Measures :
  1. Morphine consumption [ Time Frame: preoperative 24th hour ]
    Morphine consumption will be recorded


Secondary Outcome Measures :
  1. Numeric Rating Scale [ Time Frame: postoperative 24th hour ]
    A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II patients
  • Pateints undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

  • obesity (body mass index >35 kg/m2)
  • infection of the skin at the site of needle puncture area
  • patients with known allergies to any of the study drugs
  • coagulopathy
  • recent use of analgesic drugs
Contacts and Locations
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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): NCT03781687


Locations
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Turkey
Kocaeli University Hospital
İzmit, Kocaeli, Turkey, 41340
Sponsors and Collaborators
Kocaeli University
Investigators
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Principal Investigator: Can Aksu Kocaeli Üniversitesi Tıp Fakültesi
More Information
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Responsible Party: Can AKSU, Assistant Professor, Kocaeli University
ClinicalTrials.gov Identifier: NCT03781687    
Other Study ID Numbers: KIA 2018/488
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
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
Keywords provided by Can AKSU, Kocaeli University:
erector spinae plane block
postoperative pain
laparoscopic cholecystectomy
Additional relevant MeSH terms:
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Cholecystitis
Gallstones
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis
 Cholecystolithiasis
Calculi
Pathological Conditions, Anatomical
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents