The Effect of Erector Spinae Block on Diaphragma Movement

NCT05021822 | Completed Phase 4

• 1 other identifier: 2021-03
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Cholecystectomy; Acute Post-operative Pain; Respiratory Diaphragm

Outcome Measures

Primary Outcomes (3)

• Change of Diaphragma excursion

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

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

• Change in Opioid consumption

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

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

• Change in postoperative pain

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

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

Study Arms (2)

Block Group

ACTIVE COMPARATOR

Procedure: Erector spinae plane block

Control Group

NO INTERVENTION

Interventions

Erector spinae plane block PROCEDURE

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

Block Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ufuk University: lead

Study Sites (1)

Ufuk Üniversitesi Dr. Rıdvan Ege Hastanesi

Ankara, 06520, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 30288093 BACKGROUND

• 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.

  PMID: 29913392 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ülkü C Köksoy, Ass. Prof.

  Ufuk University Faculty of Medicine Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 26, 2021
• Study Start: August 26, 2021
• Primary Completion: September 18, 2021
• Study Completion: September 18, 2021
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)