Analgesic Efficacy of Different Volumes in Erector Spinae Plane Block in Single Level Lumbar Spine Fixation

Study Overview
=================
Brief Summary
-----------------
The analgesic efficacy of different volumes in ESPB patients undergoing single-level lumbar spine fixation

Detailed Description
-----------------
The erector spinae plane block (ESPB) its an interfacial plane block for an effective treatment for thoracic neuropathic pain. Currently, compared to the use of opioids, the ESPB has fewer side effects and is safe for patients of all ages having abdominal and thoracic operations .

Official Title
-----------------
Analgesic Efficacy of Different Volumes in Erector Spinae Plane Block in Patients Undergoing Single Level Lumbar Spine Fixation: A Non-inferiority Randomized Clinical Trial

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Drug: Bupivacaine 0.25% Injectable Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-65 years. Both genders. American Society of Anesthesiologists' (ASA) physical status I or II. Undergoing single level lumbar spine fixation. Exclusion Criteria: Patient refusal. Pregnant females. Renal, lung, heart, or liver disorders. Communication difficulties which might prevent a reliable postoperative assessment. Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection, known allergy to local anesthetics). BMI more than 30 kg/m2.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erector 10<br>Received 10ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side | Drug: Bupivacaine 0.25% Injectable Solution<br>* Bilateral ultrasound guided in erector spinae plane block by bupivacaine 0.25%<br>|
| Experimental: Erector 15<br>Received 15ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side | Drug: Bupivacaine 0.25% Injectable Solution<br>* Bilateral ultrasound guided in erector spinae plane block by bupivacaine 0.25%<br>|
| Experimental: Erector 20<br>Received 20ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side | Drug: Bupivacaine 0.25% Injectable Solution<br>* Bilateral ultrasound guided in erector spinae plane block by bupivacaine 0.25%<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine consumption | Patients were allowed to receive incremental doses of morphine 3mg intravenously if numerical rating scale pain score will be ≥ then the total amount of morphine will be recorded | First 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating scale | Postoperative pain using numerical rating scale (NRS) will be measured at post-anesthesia care unit, from 0 to 10, with 0 representing no pain and 10 representing maximum intolerable pain | Up to 48 hours postoperatively | 
| Time to the first rescue analgesic | If numerical rating scale >4 was observed, rescue analgesia (morphine 3 mg IV) was administered | Up to 24 hours postoperatively | 
| Postoperative complications | postoperative nausea and vomiting (PONV), hypotension (mean arterial pressure < 20% of baseline readings and was managed by ephedrine 5 mg IV and/or normal saline IVI), bradycardia (heart rate < 60 beats/min and was managed by atropine 0.6 mg IV). | Up to 24 hours postoperatively | 
| 5-point scale | The degree of patient satisfaction was assessed on a 5-point scale: (0= extremely dissatisfied, 1= unsatisfied, 2= neither satisfied nor unsatisfied, 3= satisfied), and 4= extremely satisfied). | Up to 24 hours postoperative |