The Effect of Erector Spinae Block on Diaphragma Movement

Sponsor
Ufuk University (Other)
Overall Status
Completed
CT.gov ID
NCT05021822
Collaborator
(none)
70
1
2
23
92.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Erector spinae plane block
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effect of Erector Spinae Plane Block on Diaphragma Movement in Laparoscopic Cholecystectomies
Actual Study Start Date :
Aug 26, 2021
Actual Primary Completion Date :
Sep 18, 2021
Actual Study Completion Date :
Sep 18, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Block Group

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

No Intervention: Control Group

Outcome Measures

Primary Outcome Measures

  1. Change of Diaphragma excursion [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ufuk Üniversitesi Dr. Rıdvan Ege Hastanesi Ankara Turkey 06520

Sponsors and Collaborators

  • Ufuk University

Investigators

  • Principal Investigator: Ülkü C Köksoy, Ass. Prof., Ufuk University Faculty of Medicine Department of Anesthesiology and Reanimation

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ülkü Ceren Köksoy, Associate Professor, Ufuk University
ClinicalTrials.gov Identifier:
NCT05021822
Other Study ID Numbers:
  • 2021-03
First Posted:
Aug 26, 2021
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2022