Back to resultsContinuous Ultrasound Guided Erector Spinae Plane Block vs Thoracic Paravertebral Block
Primary Purpose
Postoperative Pain
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
continuous Thoracic paravertebral block
continuous Erector spinae plane block
Sponsored by
About this trial
This is an interventional other trial for Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- Menoufia universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Compare the VAS score postoperative of (U/S)-guided continuous (ESPB) to continuous (TPVB) following thoracotomy
visual analogue scale (VAS) Score
Secondary Outcome Measures
1 st call analgesia
mg
Total rescue opioid dose used
mg
patient satisfaction at 24 hours
occurrence of adverse events
hospital stay
days
Full Information
NCT ID
NCT05898607
First Posted
June 2, 2023
Last Updated
September 11, 2023
Sponsor
Amal Gouda Elsayed Safan
Collaborators
Mohamed Emad Basune, Wesam Eldin Sultan, Rabab Mohammed Habeeb
1. Study Identification
Unique Protocol Identification Number
NCT05898607
Brief Title
Continuous Ultrasound Guided Erector Spinae Plane Block vs Thoracic Paravertebral Block
Official Title
Continuous Ultrasound Guided Erector Spinae Plane Block vs Thoracic Paravertebral Block for Postoperative Analgesia in Patients Undergoing Thoractomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
October 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amal Gouda Elsayed Safan
Collaborators
Mohamed Emad Basune, Wesam Eldin Sultan, Rabab Mohammed Habeeb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
continuous Thoracic paravertebral block
Other Intervention Name(s)
TPVB
Intervention Description
continuous infusion U/S-Guided TPVB of 5 ml/hr of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative.
Intervention Type
Other
Intervention Name(s)
continuous Erector spinae plane block
Other Intervention Name(s)
ESPB
Intervention Description
continuous U/S-Guided ESPB of 5 ml/hr of 0.125% bupivacaine started through the catheter before the surgical procedure
Primary Outcome Measure Information:
Title
Compare the VAS score postoperative of (U/S)-guided continuous (ESPB) to continuous (TPVB) following thoracotomy
Description
visual analogue scale (VAS) Score
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
1 st call analgesia
Description
mg
Time Frame
1 hour
Title
Total rescue opioid dose used
Description
mg
Time Frame
48 hour
Title
patient satisfaction at 24 hours
Time Frame
24 hours
Title
occurrence of adverse events
Time Frame
24hours
Title
hospital stay
Description
days
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AMAL G SAFAN, MD
Phone
+14007736
Email
AMAL.GODA52@med.menofia.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Rabab Mohamed Habeeb, MD
Email
rababhabeeb39@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wesam Eldin Sultan, MD
Organizational Affiliation
Menoufia University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Emad Basune
Organizational Affiliation
Menoufia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Menoufia university
City
Cairo
State/Province
Shibin Elkom
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AMAL G SAFAN, MD
Phone
0102738621
Email
AMAL.GODA52@med.menofia.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Continuous Ultrasound Guided Erector Spinae Plane Block vs Thoracic Paravertebral Block
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