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Completed

NCT Number: NCT05021822

The Effect of Erector Spinae Block on Diaphragma Movement

Laparoscopic cholecystectomy surgeries cause moderate/severe pain and thus can result in shallow breathing, atelectasis and increased opioid consumption in the early postoperative period which in turn cause a longer hospital stay. Erector spinae plane block has been shown to decrease lower thoracic pain after laparoscopic cholecystectomy surgeries. This study aims to investigate the effect of erector spinae plane block on opioid consumption and diaphragma movement after laparoscopic cholecystectomy surgeries.

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Key information

Conditions

Laparoscopic Cholecystectomy Acute Post-operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiratory Diaphragm Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ufuk Üniversitesi Dr. Rıdvan Ege Hastanesi

Ankara, 06520, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ages between 18 and 65
  • Patients in American Society of Anesthesiologists Classification I or II
  • Elective laparoscopic cholecystectomy surgery performed under general anesthesia

Exclusion criteria

  • Patient refusal
  • Patients who can not provide informed consent or with a known psychiatric disease
  • Patients with a known allergy to study drugs
  • Patients using anticoagulants and corticosteroids
  • Patients with diaphragma hernia, chronic obstructive pulmonary disease, lung cancer
  • Patients who are not able to use a patient controlled analgesia device

Treatment and study plan

Erector Spinae Plane Block

Procedure

Bilateral erector spinae plane block will be performed preoperatively under ultrasound guidance using 15 ml bupivacaine on each side

Primary outcomes

  1. Change of Diaphragma excursion

    Time frame: Preoperative measurement-before the erector spina plane block application and postoperative measurement- 30 minutes after extubation

    The change of diaphragma excursion as measured by ultrasound in M-mode from the preoperative period to the postoperative period

  2. Change in Opioid consumption

    Time frame: Postoperative 12 hours: in the first 30 minutes after extubation, 1st hour, 6th hour and 12th hour

    To assess Tramadol consumption measured in mg postoperatively in the first 12 hours after the operation

  3. Change in postoperative pain

    Time frame: Postoperative 12 hours: in the first 30 minutes after extubation, 1st hour, 6th hour and 12th hour

    Postoperative pain will be measured with visual analog scale and numeric scale in the first 12 hours after the operation

Sponsors and collaborators

Lead sponsor

Ufuk University

Other

Registry information

Official study title

The Effect of Erector Spinae Plane Block on Diaphragma Movement in Laparoscopic Cholecystectomies

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 26, 2021
Registry last updated
Aug 10, 2022

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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