Continuous Ultrasound Guided Erector Spinae Plane Block vs Thoracic Paravertebral Block

NCT05898607 | Completed

• 1 other identifier: 2/2023ANET10-25
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

in this study the investigators will investigate and compare the analgesic efficacy of two techniques (continuous TPVB and continuous ESPB) in relieving thoracotomy pain

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Compare the VAS score postoperative of (U/S)-guided continuous (ESPB) to continuous (TPVB) following thoracotomy

  visual analogue scale (VAS) Score

  48 hours

Secondary Outcomes (5)

• 1 st call analgesia

  1 hour

• Total rescue opioid dose used

  48 hour

• patient satisfaction at 24 hours

  24 hours

• occurrence of adverse events

  24hours

• hospital stay

  1 week

Study Arms (2)

Group A

ACTIVE COMPARATOR

Patients will receive Loading dose of 20 ml 0.25% bupivacaine then continuous infusion U/S-Guided TPVB of 5 ml/hr of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative

Other: continuous Thoracic paravertebral block

Group B

ACTIVE COMPARATOR

Patients will receive Loading dose of 20 ml 0.25% bupivacaine then continuous U/S-Guided ESPB of 5 ml/hr of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative.

Other: continuous Erector spinae plane block

Interventions

continuous Thoracic paravertebral block OTHER

continuous infusion U/S-Guided TPVB of 5 ml/hr of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative.

Also known as: TPVB

Group A

continuous Erector spinae plane block OTHER

continuous U/S-Guided ESPB of 5 ml/hr of 0.125% bupivacaine started through the catheter before the surgical procedure

Also known as: ESPB

Group B

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Eligible 40 patients will be older than 21 years old with American society of anesthesia physical status I\& II scheduled for elective thoracotomy

You may not qualify if:

• Patients who are:
• Uncooperative.
• Having allergy to any of the study drugs.
• Known abuse of alcohol or medication.
• Having Local infection at the site of injection or systemic infection.
• Pregnancy.
• With coagulation disorders or on anticoagulation therapy

Sponsors & Collaborators

• Amal Gouda Elsayed Safan: lead
• Mohamed Emad Basune: collaborator
• Wesam Eldin Sultan: collaborator
• Rabab Mohammed Habeeb: collaborator

Study Sites (1)

Menoufia university

Cairo, Shibin Elkom, 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 Officials

• Wesam Eldin Sultan, MD

  Menoufia University

  STUDY DIRECTOR

• Mohamed Emad Basune

  Menoufia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer of anaethesia

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 12, 2023
• Study Start: February 10, 2023
• Primary Completion: October 10, 2023
• Study Completion: January 25, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)