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

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Erector Spinae Plane Block

Intrathecal morphine

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

Assiut University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Erector Spinae Plane Block

Intrathecal morphine ITM

Arm Description

Patients will receive Erector spinae plane block.

Patients will receive Intrathecal morphine.

Outcomes

Primary Outcome Measures

Cumulative opioid consumption

Nalbuphine consumption in mg equivalent to morphine dose

Secondary Outcome Measures

Nalbuphine consumption in mg

equivalent to morphine dose

Analgesic drug consumption other than nalbuphine

consumption in mg

Numerical Rating Scale (NRS) at rest and when coughing

NRS is an 11-point (0=no pain and 10=worst pain)

Heart Rate

Heart Rate in beats /min

Mean Arterial Pressure

Mean Arterial Pressure in mmHg

Incidence of Postoperative nausea & vomiting (PONV)

Number of patients developing PONV

Full Information

NCT ID

NCT04635644

First Posted

November 14, 2020

Last Updated

May 19, 2023

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT04635644

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

November 15, 2021 (Actual)

Primary Completion Date

February 15, 2023 (Actual)

Study Completion Date

March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Erector Spinae Plane Block

Arm Type

Active Comparator

Arm Description

Patients will receive Erector spinae plane block.

Arm Title

Intrathecal morphine ITM

Arm Type

Active Comparator

Arm Description

Patients will receive Intrathecal morphine.

Intervention Type

Procedure

Intervention Name(s)

Erector Spinae Plane Block

Other Intervention Name(s)

ESP block

Intervention Description

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

Intervention Name(s)

Intrathecal morphine

Other Intervention Name(s)

ITM

Intervention Description

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.

Primary Outcome Measure Information:

Title

Cumulative opioid consumption

Description

Nalbuphine consumption in mg equivalent to morphine dose

Time Frame

24 hours postoperatively

Secondary Outcome Measure Information:

Title

Nalbuphine consumption in mg

Description

equivalent to morphine dose

Time Frame

at 8, 48, and 72 hours postoperatively.

Title

Analgesic drug consumption other than nalbuphine

Description

consumption in mg

Time Frame

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

Title

Numerical Rating Scale (NRS) at rest and when coughing

Description

NRS is an 11-point (0=no pain and 10=worst pain)

Time Frame

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

Title

Heart Rate

Description

Heart Rate in beats /min

Time Frame

Intraoperatively

Title

Mean Arterial Pressure

Description

Mean Arterial Pressure in mmHg

Time Frame

Intraoperatively

Title

Incidence of Postoperative nausea & vomiting (PONV)

Description

Number of patients developing PONV

Time Frame

24 hours postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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,

Facility Information:

Facility Name

Assiut University hospital

City

Assiut

State/Province

Asyut Governorate

ZIP/Postal Code

11111

Country

Egypt

12. IPD Sharing Statement

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

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