- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07387484
Effect of Patient Position on Erector Spinae Plane Block in Thoracic Surgery
Effect of Patient Position on Dermatomal Spread and Analgesic Outcomes of Erector Spinae Plane Block in Thoracic Surgery: A Prospective Randomized Clinical Trial
The erector spinae plane (ESP) block is a widely used regional anesthesia technique for postoperative analgesia in thoracic surgery. The block can be performed in different patient positions, most commonly sitting or lateral decubitus, but the effect of patient position on dermatomal sensory spread and analgesic efficacy has not been clearly established.
This prospective, randomized, single-blind clinical trial aims to compare the effects of ESP block performed in sitting versus lateral decubitus position on dermatomal sensory distribution and postoperative analgesic outcomes in patients undergoing video-assisted thoracic surgery.
Study Overview
Status
Detailed Description
Adult patients scheduled for elective video-assisted thoracic surgery will be randomly assigned to receive ultrasound-guided unilateral erector spinae plane block either in the sitting position or in the lateral decubitus position. In both groups, the block will be performed at the same thoracic level using 30 mL of 0.25% bupivacaine under ultrasound guidance.
Dermatomal sensory spread will be assessed 15 minutes after block placement using cold sensation (alcohol-soaked cotton) and pin-prick testing. Postoperative analgesia will be standardized in all patients using patient-controlled analgesia with tramadol. Pain scores and opioid consumption will be recorded during the first 24 postoperative hours.
The primary outcome is the extent of dermatomal sensory spread. Secondary outcomes include postoperative pain scores, time to first rescue analgesic, and total opioid consumption within 24 hours.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 to 75 years
- ASA physical status II-IV
- Scheduled for elective video-assisted thoracic surgery
- Ability to provide written informed consent
Exclusion Criteria:
- Known allergy to local anesthetics
- Chronic opioid use
- Preexisting chronic pain
- Severe cognitive impairment
- Technical difficulty with positioning
- Emergency surgery
- Refusal to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Sitting Position Group
Intervention: Erector Spinae Plane Block Ultrasound-guided unilateral erector spinae plane block performed in the sitting position using 30 mL of 0.25% bupivacaine.
|
Erector spinae plane block-sitting position
|
|
Experimental: Lateral Decubitus Position Group
Intervention: Erector Spinae Plane Block Ultrasound-guided unilateral erector spinae plane block performed in the lateral decubitus position (operative side up) using 30 mL of 0.25% bupivacaine.
|
Erector Spinae Plane Block-Lateral position
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dermatomal sensory spread
Time Frame: 15 minutes after the block application
|
Cranial and caudal sensory limits and total number of dermatomes affected, assessed by cold sensation and pin-prick testing.
|
15 minutes after the block application
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total opioid consumption
Time Frame: First 24 postoperative hours
|
First 24 postoperative hours
|
|
|
Postoperative pain scores (Numeric Rating Scale)
Time Frame: Postoperative 0, 2, 6, 12, and 24 hours
|
Numeric Rating Scale, 0-10 points, 0=no pain, 10= worst pain imaginable
|
Postoperative 0, 2, 6, 12, and 24 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
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
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Organic Chemicals
- Anilides
- Amides
- Aniline Compounds
- Amines
- Behavioral Disciplines and Activities
- Digestive System and Oral Physiological Phenomena
- Behavioral Sciences
- Dentistry
- Dental Physiological Phenomena
- Posture
- Bupivacaine
- Dental Occlusion
- Parapsychology
- Sitting Position
Other Study ID Numbers
- ESP_position
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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