Back to resultsAnalgesia After Video-Assisted Thoracic Surgery
Primary Purpose
Post Operative Pain
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound-guided deep serratus anterior plane block with isobaric bupivacaine
Local wound infiltration with isobaric bupivacaine
Ultrasound-guided thoracic paravertebral block with isobaric bupivacaine
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About this trial
This is an interventional prevention trial for Post Operative Pain
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for uniportal VATS under general anesthesia, ASA status I-III, aged from 18 to 70 years old of both sex.
Exclusion Criteria:
- Contraindications to regional block
- Pregnancy
- Body mass index (BMI) > 30 Kg/m2
- Psychiatric diseases
- Severe renal, liver, or cardiac dysfunction
Sites / Locations
- Seham M. MoeenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Group I
Group II
Group III
Arm Description
Patients will receive ultrasound-guided deep serratus anterior plane block.
Patients will receive local wound infiltration (LWI).
Patients will receive ultrasound-guided thoracic paravertebral block.
Outcomes
Primary Outcome Measures
Time to first analgesic requirement
Assessed in minutes
Secondary Outcome Measures
Postoperative pain intensity
Assessed by the numerical rating pain scale, an 11-point scale graded from 0 to 10 (0 = no pain, 10 = the worst imaginable pain)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05094323
Brief Title
Analgesia After Video-Assisted Thoracic Surgery
Official Title
Analgesic Efficacy of Ultrasound-Guided Deep Serratus Anterior Plane Block, Local Wound Infiltration, and Thoracic Paravertebral Block After Uniportal Video-Assisted Thoracic Surgery: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2022 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Although less invasive, postoperative analgesia remains challenging in patients undergoing uniportal video-assisted thoracic surgery (VATS).
Detailed Description
Although less invasive, postoperative analgesia remains challenging in patients undergoing uniportal video-assisted thoracic surgery (VATS).
Adequate postoperative pain relief is imperative to hasten functional recovery, accelerate discharge from the hospital, and reduce chronic postsurgical pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Active Comparator
Arm Description
Patients will receive ultrasound-guided deep serratus anterior plane block.
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
Patients will receive local wound infiltration (LWI).
Arm Title
Group III
Arm Type
Placebo Comparator
Arm Description
Patients will receive ultrasound-guided thoracic paravertebral block.
Intervention Type
Drug
Intervention Name(s)
Ultrasound-guided deep serratus anterior plane block with isobaric bupivacaine
Intervention Description
Patients will receive ultrasound-guided deep serratus anterior plane block with isobaric bupivacaine.
Intervention Type
Drug
Intervention Name(s)
Local wound infiltration with isobaric bupivacaine
Intervention Description
Patients will receive local wound infiltration with isobaric bupivacaine.
Intervention Type
Drug
Intervention Name(s)
Ultrasound-guided thoracic paravertebral block with isobaric bupivacaine
Intervention Description
Patients will receive ultrasound-guided thoracic paravertebral block with isobaric bupivacaine.
Primary Outcome Measure Information:
Title
Time to first analgesic requirement
Description
Assessed in minutes
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Postoperative pain intensity
Description
Assessed by the numerical rating pain scale, an 11-point scale graded from 0 to 10 (0 = no pain, 10 = the worst imaginable pain)
Time Frame
24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for uniportal VATS under general anesthesia, ASA status I-III, aged from 18 to 70 years old of both sex.
Exclusion Criteria:
Contraindications to regional block
Pregnancy
Body mass index (BMI) > 30 Kg/m2
Psychiatric diseases
Severe renal, liver, or cardiac dysfunction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seham M Moeen, MD
Phone
01006386324
Ext
02
Email
seham.moeen@aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed K Fathy, Msc
Phone
01098774731
Ext
02
Email
Ahmedkhaledf@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seham M Moeen, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seham M. Moeen
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seham M Moeen, MD
Phone
01006386324
Ext
02
Email
seham.moeen@aun.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Analgesia After Video-Assisted Thoracic Surgery
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