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Completed

NCT Number: NCT03781687

Bilateral vs. Unilateral Erector Spinae Plane Block

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.

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Key information

Conditions

Postoperative Pain Biliary Tract Diseases Calculi Cholecystitis Cholecystitis; Gallstone Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases Gallstones Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University Hospital

İzmit, Kocaeli, 41340, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilateral ESP Block

Procedure

Bilateral ESP Block will be performed at T8

Unilateral ESP Block

Procedure

Unilateral ESP Block will be performed at T8 (right side)

Intravenous Morphine patient controlled analgesia device

Device

24 hour morphine consumption will be recorded

Primary outcomes

  1. Morphine consumption

    Time frame: preoperative 24th hour

    Morphine consumption will be recorded

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

Bilateral vs. Unilateral Erector Spinae Plane Block for Laparoscopic Cholecystectomy; A Randomised Controlled Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2018
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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