- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05152602
Comparation of Bilateral and Unilateral Erector Spinae Plane Block
January 9, 2023 updated by: Ankara City Hospital Bilkent
Effect of Bilateral and Unilateral Erector Spinae Plane Block on Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy
Although laparoscopic cholecystectomy is a minimally invasive surgery with many advantages, it is one of the operations with high postoperative pain scores.
Opioids are frequently used to prevent postoperative pain.
Due to the side effects of opioids, the amount of use is tried to be reduced.
Regional anesthesia techniques can be used to minimize opioid consumption.
Erector spina plane block was first described in 2016 by Forero et al. in the treatment of thoracic neuropathic pain.
Since then, ESP block has been used as an anesthetic and analgesic technique.
It is applied by injecting local anesthetic into the fascial plane located between the erector spina muscle and the transverse process of the vertebra.
Several high-level studies have shown that the ESP block can be used to reduce postoperative pain after gastrointestinal surgery.
Several studies have evaluated the effect of ESP block for pain relief after laparoscopic cholecystectomy.
ESP block has been applied unilaterally or bilaterally in various studies.
However, in the current studies in the literature, the advantages or disadvantages of the bilateral application of the ESP block compared to the unilateral application have not been evaluated.
In this study, the investigators aimed to evaluate postoperative pain by applying ESP block to patients who underwent laparoscopic cholecystectomy and to evaluate the advantages of unilateral or bilateral application of ESP block over each other.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
54
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey, 06800
- Ankara City Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who had laparoscopic cholecystectomy between December 2021 and January 2022.
Description
Inclusion Criteria:
- Patients who underwent laparoscopic cholecystectomy surgery between December 2021 and January 2022 will participate in the study.
Exclusion Criteria:
- There is no exclusion criteria for the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Unilateral ESP block group
The group who underwent laparoscopic cholecystectomy and underwent unilateral ESP block for postoperative analgesia.
|
Erector spinae plane (ESP) block is an interfascial plane block where a local anaesthetic is injected in a plane preferably below the erector spinae muscle.
It is supposed to work at the origin of spinal nerves based on cadaveric and contrast study.
It has emerged as an effective and safe analgesic regional technique.
It will be done at T7-8 level
|
Bilateral ESP block group
The group who underwent laparoscopic cholecystectomy and underwent bilateral ESP block for postoperative analgesia.
|
Erector spinae plane (ESP) block is an interfascial plane block where a local anaesthetic is injected in a plane preferably below the erector spinae muscle.
It is supposed to work at the origin of spinal nerves based on cadaveric and contrast study.
It has emerged as an effective and safe analgesic regional technique.
It will be done at T7-8 level
|
Control group
The group that underwent laparoscopic cholecystectomy and underwent 1mg/kg tramadol and 50mg dexketoprofen for postoperative pain.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog scale
Time Frame: 0-24 hour
|
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
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0-24 hour
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Opioid consumption
Time Frame: 24 hour
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Total usage of opioid's dosage when the patients VAS scores over than the four
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24 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ayça T. Dumanlı Özcan, Assoc. Prof., Ankara City Hospital Bilkent
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Huang J, Liu JC. Ultrasound-guided erector spinae plane block for postoperative analgesia: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 Apr 14;20(1):83. doi: 10.1186/s12871-020-00999-8.
- Sercan O, Karaveli A, Ozmen S, Uslu A. Comparison of the Effects of Pectoral Nerve Block and Local Infiltration Anesthesia on Postoperative Pain for Breast Reduction Surgery: A Prospective Observational Study. Eurasian J Med. 2021 Jun;53(2):102-107. doi: 10.5152/eurasianjmed.2021.20111.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
February 28, 2022
Study Completion (Actual)
March 10, 2022
Study Registration Dates
First Submitted
November 29, 2021
First Submitted That Met QC Criteria
November 29, 2021
First Posted (Actual)
December 10, 2021
Study Record Updates
Last Update Posted (Estimate)
January 10, 2023
Last Update Submitted That Met QC Criteria
January 9, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2-21-228
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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