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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: Erector Spinae Plane Block; Procedure: Intrathecal morphine

• Registration Number: NCT04635644
• Lead Sponsor: Assiut University

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-14
• Study First Submitted QC: 2020-11-14
• Study First Posted: 2020-11-19
• Study Start: 2021-11-15
• Primary Completion: 2023-02-15
• Study Completion: 2023-03-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-19
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector Spinae Plane Block	Erector Spinae Plane Block	Patients will receive Erector spinae plane block.
Intrathecal morphine ITM	Intrathecal morphine	Patients will receive Intrathecal morphine.

Primary Outcome Measures

Name	Time	Method
Cumulative opioid consumption	24 hours postoperatively	Nalbuphine consumption in mg equivalent to morphine dose

Secondary Outcome Measures

Name	Time	Method
Nalbuphine consumption in mg	at 8, 48, and 72 hours postoperatively.	equivalent to morphine dose
Analgesic drug consumption other than nalbuphine	at 8, 24, 48, and 72 hours postoperatively.	consumption in mg
Numerical Rating Scale (NRS) at rest and when coughing	at 1, 2, 4, 8, 12, 24, 48 and 72 hours postoperatively	NRS is an 11-point (0=no pain and 10=worst pain)
Heart Rate	Intraoperatively	Heart Rate in beats /min
Incidence of Postoperative nausea & vomiting (PONV)	24 hours postoperatively	Number of patients developing PONV
Mean Arterial Pressure	Intraoperatively	Mean Arterial Pressure in mmHg

Trial Locations

Locations (1)

Assiut University hospital; 🇪🇬 Assiut, Asyut Governorate, Egypt