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

NCT04635644 | Completed DMC

• 1 other identifier: ABC-4-DE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Cumulative opioid consumption

  Nalbuphine consumption in mg equivalent to morphine dose

  24 hours postoperatively

Secondary Outcomes (6)

• Nalbuphine consumption in mg

  at 8, 48, and 72 hours postoperatively.

• Analgesic drug consumption other than nalbuphine

  at 8, 24, 48, and 72 hours postoperatively.

• Numerical Rating Scale (NRS) at rest and when coughing

  at 1, 2, 4, 8, 12, 24, 48 and 72 hours postoperatively

• Heart Rate

  Intraoperatively

• Mean Arterial Pressure

  Intraoperatively

Study Arms (2)

Erector Spinae Plane Block

ACTIVE COMPARATOR

Patients will receive Erector spinae plane block.

Procedure: Erector Spinae Plane Block

Intrathecal morphine ITM

ACTIVE COMPARATOR

Patients will receive Intrathecal morphine.

Procedure: Intrathecal morphine

Interventions

Erector Spinae Plane Block PROCEDURE

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.

Also known as: ESP block

Erector Spinae Plane Block

Intrathecal morphine PROCEDURE

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.

Also known as: ITM

Intrathecal morphine ITM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospital

Asyut, Asyut Governorate, 11111, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2020
• First Posted: November 19, 2020
• Study Start: November 15, 2021
• Primary Completion: February 15, 2023
• Study Completion: March 15, 2023
• Last Updated: May 22, 2023

Record last verified: 2023-05

Locations

EG (1)