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

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

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)

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Erector Spinae Plane Block; Procedure: Intrathecal morphine

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magdy M. Mahdy, Lecturer; Phone Number: 01096502058; Email: magdy.mahdy@aun.edu.eg

Study Locations

• Egypt
  • Asyut Governorate
    • Assiut, Asyut Governorate, Egypt, 11111
      • Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Erector Spinae Plane Block; Patients will receive Erector spinae plane block.	Procedure: Erector Spinae Plane Block; 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.; Other Names: ESP block
Active Comparator: Intrathecal morphine ITM; Patients will receive Intrathecal morphine.	Procedure: Intrathecal morphine; 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.; 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
Incidence of Postoperative nausea & vomiting (PONV)	Number of patients developing PONV	24 hours postoperatively
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): February 15, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: November 14, 2020
• First Submitted That Met QC Criteria: November 14, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: ABC-4-DE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No