Serratus Anterior Plane Block Versus Intercostal Nerve Block for Postoperative Analgesia
Primary Purpose
Analgesia, Postoperative Pain, Lung Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Thoracoscopic lobectomy
Sponsored by
About this trial
This is an interventional treatment trial for Analgesia
Eligibility Criteria
Inclusion Criteria:
- lung cancer
- American Society of Anesthesiologists (ASA) I-III class
- Video-assisted thoracoscopic lobectomy
Exclusion Criteria:
- previous history of allergy to local anesthetics
- psychological disorder
- chronic analgesics or sedatives use
- coagulopathy
- The presence of systemic infection or local infection at injection site
- Pregnancy
Sites / Locations
- Kyungpook national university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Serratus Anterior Plane Block
Intercostal Nerve Block
Arm Description
Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance. 20ml of 0.375% ropivacaine was slowly injected between the fascia of serratus anterior and latissimus dorsi near 5th rib.
Intercostal Nerve Block was performed just before closing the surgical incision while looking directly at the affected intercostal space. 10ml of 0.375% ropivacaine was delivered evenly at anterior and posterior intercostal spaces from the port site.
Outcomes
Primary Outcome Measures
Postoperative pain: numeric rating scale
Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)
Postoperative pain: numeric rating scale
Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)
Postoperative pain: numeric rating scale
Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)
Postoperative pain: numeric rating scale
Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)
Postoperative pain: numeric rating scale
Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)
Secondary Outcome Measures
Number of analgesics consumption
If the participant has additional analgesic requirement postoperatively, ketorolac 30mg will be injected intravenously when numeric rating scale score is measured as 4-5, and fentanyl 50# is injected when numeric rating scale score is over 6.
Amount of analgesics consumption
If the participant has additional analgesic requirement postoperatively, ketorolac 30mg will be injected intravenously when numeric rating scale score is measured as 4-5, and fentanyl 50# is injected when numeric rating scale score is over 6.
Full Information
NCT ID
NCT04250272
First Posted
January 29, 2020
Last Updated
January 29, 2020
Sponsor
Kyungpook National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04250272
Brief Title
Serratus Anterior Plane Block Versus Intercostal Nerve Block for Postoperative Analgesia
Official Title
Serratus Anterior Plane Block vs. Intercostal Nerve Block for Postoperative Analgesic Effect After Video-assisted Thoracoscopic Lobectomy: A Randomized Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 16, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Anticipated)
Study Completion Date
February 29, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital
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
A prospective randomized controlled study was undertaken to compare the postoperative analgesic effect between ultrasound-guided serratus anterior plane block and intercostal nerve block after video-assisted thoracoscopic lobectomy.
Detailed Description
Post-thoracotomy pain is one of the most notorious postsurgical pains that one can experience. The pain is known to last for an extensive period of time with significantly high intensity.
In field of thoracic surgery, video-assisted thoracoscopic surgery has been played an important role in alleviating the postoperative pain. In field of anesthesiology, various attempts to alleviate post-thoracotomy pain have been tried along advancement of thoracic surgical techniques. It began with postoperative medication of non-steroid anti-inflammatory drugs, opioids and progressed into implementations such as local analgesia, thoracic epidural block, paravertebral block, intercostal nerve block, interpleural block and serratus anterior plane block.
Many analgesic methods have been applied to alleviate postoperative pain in patients who have undergone thoracoscopic surgeries. However, there are no prospective randomized controlled studies between intercostal nerve block and serratus anterior plane block in video-assisted thoracoscopic lobectomy. The main purpose of this study is to compare and analyze the effects between conventional intercostal nerve block and newly introduced serratus anterior plane block in lung cancer patients who have undergone video-assisted thoracoscopic lobectomy.
This prospective study will discover the efficacy and differences between two methods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Postoperative Pain, Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Serratus Anterior Plane Block
Arm Type
Experimental
Arm Description
Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance. 20ml of 0.375% ropivacaine was slowly injected between the fascia of serratus anterior and latissimus dorsi near 5th rib.
Arm Title
Intercostal Nerve Block
Arm Type
Active Comparator
Arm Description
Intercostal Nerve Block was performed just before closing the surgical incision while looking directly at the affected intercostal space. 10ml of 0.375% ropivacaine was delivered evenly at anterior and posterior intercostal spaces from the port site.
Intervention Type
Procedure
Intervention Name(s)
Thoracoscopic lobectomy
Intervention Description
Thoracoscopic lobectomy was performed for lung cancer
Primary Outcome Measure Information:
Title
Postoperative pain: numeric rating scale
Description
Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)
Time Frame
at postanesthesia care unit (PACU)
Title
Postoperative pain: numeric rating scale
Description
Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)
Time Frame
3 hours later operation
Title
Postoperative pain: numeric rating scale
Description
Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)
Time Frame
6 hours later operation
Title
Postoperative pain: numeric rating scale
Description
Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)
Time Frame
12 hours later operation
Title
Postoperative pain: numeric rating scale
Description
Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)
Time Frame
24 hours later operation
Secondary Outcome Measure Information:
Title
Number of analgesics consumption
Description
If the participant has additional analgesic requirement postoperatively, ketorolac 30mg will be injected intravenously when numeric rating scale score is measured as 4-5, and fentanyl 50# is injected when numeric rating scale score is over 6.
Time Frame
through study completion, an average of 1 yea
Title
Amount of analgesics consumption
Description
If the participant has additional analgesic requirement postoperatively, ketorolac 30mg will be injected intravenously when numeric rating scale score is measured as 4-5, and fentanyl 50# is injected when numeric rating scale score is over 6.
Time Frame
: through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
lung cancer
American Society of Anesthesiologists (ASA) I-III class
Video-assisted thoracoscopic lobectomy
Exclusion Criteria:
previous history of allergy to local anesthetics
psychological disorder
chronic analgesics or sedatives use
coagulopathy
The presence of systemic infection or local infection at injection site
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jimin Heo
Phone
+82-53-420-5430
Email
knuhmrc@knu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Saeyoung Kim
Phone
+82-53-420-5873
Email
saeyoungkim7@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saeyoung Kim
Organizational Affiliation
Kyungpook National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyungpook national university hospital
City
Daegu
ZIP/Postal Code
700-412
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jimin Heo
Phone
82-53-420-5430
Email
knuhmrc@knu.ac.kr
12. IPD Sharing Statement
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Serratus Anterior Plane Block Versus Intercostal Nerve Block for Postoperative Analgesia
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