Ultrasound Guided ESP Block Versus Intrathecal Morphine for Postoperative Analgesia in Major HPB Surgery.

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of USG-guided bilateral Erector spinae plane block (ESPB) with intrathecal morphine (ITM) for postoperative analgesia after major hepatopancreaticobiliary surgery (HPB)

Official Title
-----------------
Ultrasound Guided Erector Spinae Block Versus Intrathecal Morphine for Postoperative Analgesia in Major Hepatopancreaticobiliary Surgery

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

Intervention / Treatment
-----------------
* Procedure: Erector Spinae Plane Block
* Procedure: Intrathecal morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2, patients with the American Society of Anesthesiologists (ASA) physical status I - II, Patients scheduled for elective major hepatopancreaticobiliary surgery for benign or malignant disease; major surgery is defined as an operation of anticipated duration of more than one hour. Exclusion Criteria: Patient's refusal Allergy or contraindications to the study drugs, Infection at the site of injection, Coagulopathy, Psychiatric disorders Severely co-morbid patients, Chronic pain syndromes, Prolonged opioid medication,

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Erector Spinae Plane Block<br>Patients will receive Erector spinae plane block. | Procedure: Erector Spinae Plane Block<br>* Patients will be turned into the prone position. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T8 spinous process. The erector spinae muscles will be identified superficial to the tip of the T8 transverse process. After local infiltration of the needle insertion site with 2-3 ml of 2% lidocaine, a 21G 10 cm needle will be inserted using an in-plane approach in a cranial to caudal direction to contact the T8 transverse process. The location of the needle tip will be confirmed by hydrodissection with 2 mL of lidocaine 2% and visualizing linear fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of 0.25% Bupivacaine is injected will be injected at this point. The same procedure will be repeated for the opposite side.<br>* Other names: ESP block;|
| Active Comparator: Intrathecal morphine ITM<br>Patients will receive Intrathecal morphine. | Procedure: Intrathecal morphine<br>* Patients will be placed on their right side. An intrathecal injection of morphine 200 μg (0.2 mL of morphine sulfate 1 mg/mL) diluted in 1.8 mL normal saline will be administered at the L3-L4 or L4-L5 level with a 25 G Whitacre spinal needle.<br>* Other names: ITM;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative opioid consumption | Nalbuphine consumption in mg equivalent to morphine dose | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nalbuphine consumption in mg | equivalent to morphine dose | at 8, 48, and 72 hours postoperatively. | 
| Analgesic drug consumption other than nalbuphine | consumption in mg | at 8, 24, 48, and 72 hours postoperatively. | 
| Numerical Rating Scale (NRS) at rest and when coughing | NRS is an 11-point (0=no pain and 10=worst pain) | at 1, 2, 4, 8, 12, 24, 48 and 72 hours postoperatively | 
| Heart Rate | Heart Rate in beats /min | Intraoperatively | 
| Mean Arterial Pressure | Mean Arterial Pressure in mmHg | Intraoperatively | 
| Incidence of Postoperative nausea & vomiting (PONV) | Number of patients developing PONV | 24 hours postoperatively |