Analgesia After Video-Assisted Thoracic Surgery
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 Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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.
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
Study Contact
- Name: Ahmed K Fathy, Msc
- Phone Number: 02 01098774731
- Email: Ahmedkhaledf@yahoo.com
Study Locations
-
-
-
Asyut, Egypt, 71111
- Seham M. Moeen
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Group I
Patients will receive ultrasound-guided deep serratus anterior plane block.
|
Patients will receive ultrasound-guided deep serratus anterior plane block with isobaric bupivacaine.
|
|
Active Comparator: Group II
Patients will receive local wound infiltration (LWI).
|
Patients will receive local wound infiltration with isobaric bupivacaine.
|
|
Placebo Comparator: Group III
Patients will receive ultrasound-guided thoracic paravertebral block.
|
Patients will receive ultrasound-guided thoracic paravertebral block with isobaric bupivacaine.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to first analgesic requirement
Time Frame: 24 hours after surgery
|
Assessed in minutes
|
24 hours after surgery
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain intensity
Time Frame: 24 hours after surgery
|
Assessed by the numerical rating pain scale, an 11-point scale graded from 0 to 10 (0 = no pain, 10 = the worst imaginable pain)
|
24 hours after surgery
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Seham M Moeen, MD, Assiut University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Bupivacaine
Other Study ID Numbers
Other Study ID Numbers
- 10 2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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