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CompletedNCT05021822Updated Aug 10, 2022

The Effect of Erector Spinae Block on Diaphragma Movement

A Phase 4 interventional study of Erector spinae plane block in Laparoscopic Cholecystectomy, Acute Post-operative Pain and Respiratory Diaphragm, sponsored by Ufuk University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-08-10.

Sponsored by Ufuk University · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

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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Conditions studied

  • Laparoscopic Cholecystectomy
  • Acute Post-operative Pain
  • Respiratory Diaphragm

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 70 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Ufuk University is the lead sponsor of 39 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    Block Group

    Procedure: Erector spinae plane block

  • No intervention
    Control Group

Interventions

  • ProcedureErector spinae plane block

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

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What researchers measure

Primary outcomes

  1. Change of Diaphragma excursion

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

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

  2. Change in Opioid consumption

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

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

  3. Change in postoperative pain

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

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

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Study locations

1 site
  • Ufuk Üniversitesi Dr. Rıdvan Ege Hastanesi
    Ankara, 06520, Turkey
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References and documents

Publications

  • Petsas D, Pogiatzi V, Galatidis T, Drogouti M, Sofianou I, Michail A, Chatzis I, Donas G. Erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: a case report. J Pain Res. 2018 Sep 24;11:1983-1990. doi: 10.2147/JPR.S164489. eCollection 2018. PubMed 30288093 ↗
  • Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15. PubMed 29913392 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05021822
Lead sponsor
Ufuk University
Responsible party
Ülkü Ceren Köksoy (Associate Professor, Ufuk University) — Principal investigator
First posted
Aug 26, 2021
Start date
Aug 26, 2021
Primary completion
Sep 18, 2021
Completion
Sep 18, 2021
Last update
Aug 10, 2022

Study contacts

Ülkü C Köksoy, Ass. Prof.
principal investigator · Ufuk University Faculty of Medicine Department of Anesthesiology and Reanimation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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