Continuous Ultrasound Guided Erector Spinae Plane Block vs Thoracic Paravertebral Block

Sponsor

Amal Gouda Elsayed Safan (Other)

Overall Status

Recruiting

CT.gov ID

NCT05898607

Collaborator

Mohamed Emad Basune (Other), Wesam Eldin Sultan (Other), Rabab Mohammed Habeeb (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Other: continuous Thoracic paravertebral block Other: continuous Erector spinae plane block	N/A

Detailed Description

General Anesthesia will be induced with Fentanyl (1-2 μg/kg), Propofol (2-3 mg/kg), and Atracurium (0.5-0.8 mg/kg). Pressure controlled Volume guarantee Ventilation mode will be used to maintain O2 Saturation Above 98% and End tidal co2 Around 30-35 mmHg. Anesthesia will be maintained with Isoflurane 1.2 Minimum Alveolar Concentration inhalation after induction Group A: Patients will receive Loading dose of 20 ml 0.25% bupivacaine then continuous infusion U/S-Guided TPVB of 5 ml/h of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative and Group B: Patients will receive Loading dose of 20 ml 0.25% bupivacaine then continuous U/S-Guided ESPB of 5 ml/h of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Continuous Ultrasound Guided Erector Spinae Plane Block vs Thoracic Paravertebral Block for Postoperative Analgesia in Patients Undergoing Thoractomy

Actual Study Start Date :

Feb 10, 2023

Anticipated Primary Completion Date :

Aug 10, 2023

Anticipated Study Completion Date :

Sep 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A 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 continuous infusion U/S-Guided TPVB of 5 ml/hr of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative. Other Names: TPVB
Active Comparator: Group B 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 continuous U/S-Guided ESPB of 5 ml/hr of 0.125% bupivacaine started through the catheter before the surgical procedure Other Names: ESPB

Arm

Intervention/Treatment

Active Comparator: Group A

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

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

Other Names:

TPVB

Active Comparator: Group B

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

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

Other Names:

ESPB

Outcome Measures

Primary Outcome Measures

Compare the VAS score postoperative of (U/S)-guided continuous (ESPB) to continuous (TPVB) following thoracotomy [48 hours]
visual analogue scale (VAS) Score

Secondary Outcome Measures

1 st call analgesia [1 hour]
mg
Total rescue opioid dose used [48 hour]
mg
patient satisfaction at 24 hours [24 hours]
occurrence of adverse events [24hours]
hospital stay [1 week]
days

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Menoufia university	Cairo	Shibin Elkom	Egypt

Sponsors and Collaborators

Amal Gouda Elsayed Safan
Mohamed Emad Basune
Wesam Eldin Sultan
Rabab Mohammed Habeeb

Investigators

Study Director: Wesam Eldin Sultan, MD, Menoufia University
Principal Investigator: Mohamed Emad Basune, Menoufia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amal Gouda Elsayed Safan, lecturer of anaethesia, Menoufia University

ClinicalTrials.gov Identifier:

NCT05898607

Other Study ID Numbers:

2/2023ANET10-25

First Posted:

Jun 12, 2023

Last Update Posted:

Jun 13, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Jun 13, 2023