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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04635644
• Other study ID #: ABC-4-DE
• Status: Completed
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: March 15, 2023

Study information

• Verified date: May 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 15, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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,

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Assiut University hospital	Assiut	Asyut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative opioid consumption	Nalbuphine consumption in mg equivalent to morphine dose	24 hours postoperatively
Secondary	Nalbuphine consumption in mg	equivalent to morphine dose	at 8, 48, and 72 hours postoperatively.
Secondary	Analgesic drug consumption other than nalbuphine	consumption in mg	at 8, 24, 48, and 72 hours postoperatively.
Secondary	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
Secondary	Heart Rate	Heart Rate in beats /min	Intraoperatively
Secondary	Mean Arterial Pressure	Mean Arterial Pressure in mmHg	Intraoperatively
Secondary	Incidence of Postoperative nausea & vomiting (PONV)	Number of patients developing PONV	24 hours postoperatively