Erector Spinae Plane Block For Lumbar Disc Hernia Repair

Study Overview
=================
Brief 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.

Official Title
-----------------
The Effect Of Erector Spinae Plane Block On Postoperative Pain Management In Lumbar Disc Hernia Repair Operation

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: Erector Spinae Plane block
* Procedure: Sham block
* Drug: Bupivacaine Hydrochloride
* Device: PCA


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Erector Spinae Plane Block<br>Erector Spinae Plane Block Group Block Drug: 0,25% bupivacaine hydrochloride (20ml) will be used for blocks | Procedure: Erector Spinae Plane block<br>* Erector Spinae plane block will be done according to hernia level using bupivacaine hydrochloride<br>Drug: Bupivacaine Hydrochloride<br>* 20 ml 0,25% Bupivacaine will be used for block performances<br>Device: PCA<br>* Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded<br>|
| Sham Comparator: Control Group<br>Sham block will be done with serum physiologic. | Procedure: Sham block<br>* Sham block will be done with serum physiologic.<br>Device: PCA<br>* Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption | morphine consumptions will be recorded | postoperative first 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lomber disc hernia, Erector spinae plane block, Postoperative pain