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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03744689
Other study ID # KIA2018/440
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date February 4, 2020

Study information

Verified date February 2020
Source Kocaeli University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pain management after lomber disc hernia repair surgery is a challenging issue for anesthetists. Erector Spinae plane block is a novel analgesic technique which could be used for this purpose. Primary aim of this double blinded randomized controlled study is to compare the analgesic efficacy of this new block technique with control group in this group of patients.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 4, 2020
Est. primary completion date February 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- ASA I-II

- Age 18-65 years

- Undergoing elective lomber disc hernia

Exclusion Criteria:

- obesity

- ASA III - IV

- infection of the skin at the site of needle puncture area

- patients with known allergies to any of the study drugs

- coagulopathy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Erector Spinae Plane block
Erector Spinae plane block will be done according to hernia level using bupivacaine hydrochloride
Sham block
Sham block will be done with serum physiologic.
Drug:
Bupivacaine Hydrochloride
20 ml 0,25% Bupivacaine will be used for block performances
Device:
PCA
Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded

Locations

Country Name City State
Turkey Kocaeli University Kocaeli

Sponsors (1)

Lead Sponsor Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Morphine consumption morphine consumptions will be recorded postoperative first 24 hour
Secondary Numeric rating scale Numeric rating scale for pain will be used for pain evaluation. The scale is scored in a range of 0-10 with 0 representing no pain 10 representing the highest degree of pain. postoperative first 24 hour
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