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Erector Spinae Plane Block for Postoperative Analgesia for Laparoscopic Cholecystectomy

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: NCT03420703
Recruitment Status : Completed
First Posted : February 5, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Can AKSU, Kocaeli University

Study Description
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Brief Summary:
Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented application of this blockade into practice at the clinic. Main purpose of this study is to evaluate the analgesic effect of ultrasound guided erector spinae block in laparoscopic cholecystectomy.

Condition or disease Intervention/treatment Phase
Postoperative Pain Other: erector spinae plane block Device: Intravenous morphine patient controlled analgesia device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Erector Spinae Plane Block on Postoperative Pain Following Laparoscopic Cholecystectomy: A Randomized Controlled Study
Actual Study Start Date : February 24, 2018
Actual Primary Completion Date : April 18, 2018
Actual Study Completion Date : April 18, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Block group
Erector espine plane block will be administrated to this group. An intravenous patient controlled analgesia device will be given to the patients postoperatively
 Other: erector spinae plane block
ultrasound guided erector spinae plane block will be administered to this group.

Device: Intravenous morphine patient controlled analgesia device
Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded
Sham Comparator: control group
An intravenous patient controlled analgesia device will be given to the patients postoperatively
 Device: Intravenous morphine patient controlled analgesia device
Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded


Outcome Measures
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Primary Outcome Measures :
  1. 24h morphine consumption [ Time Frame: for postoperative 24 hour ]
    morphine consumptions for both group will be recorded


Secondary Outcome Measures :
  1. Postoperative nausea and vomiting [ Time Frame: 24 hour ]
    PONV after surgery was questioned

  2. Pain [ Time Frame: 24h ]
    Numeric rating scales were recorded


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 25 - 75 years of age
  • ASA I - II
  • Undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

  • obesity
  • ASA III - IV
  • 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): NCT03420703


Locations
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Turkey
Kocaeli University Hospital
İzmit, Kocaeli, Turkey, 41340
Sponsors and Collaborators
Kocaeli University
More Information
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Responsible Party: Can AKSU, Assistant Professor, Kocaeli University
ClinicalTrials.gov Identifier: NCT03420703    
Other Study ID Numbers: 2017-349
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
laparoscopic cholecystectomy
postoperative pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Morphine
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents