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

NCT ID: NCT04635644

Last Updated: 2023-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2023-03-15

Brief Summary

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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)

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Erector Spinae Plane Block

Patients will receive Erector spinae plane block.

Group Type ACTIVE_COMPARATOR

Erector Spinae Plane Block

Intervention Type 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.

Intrathecal morphine ITM

Patients will receive Intrathecal morphine.

Group Type ACTIVE_COMPARATOR

Intrathecal morphine

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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ESP block ITM

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Magdy Mohammed Mahdy Sayed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University hospital

Asyut, Asyut Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ABC-4-DE

Identifier Type: -

Identifier Source: org_study_id

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