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Ultrasound-Guided Serratus Anterior Plane Block in Pneumothorax Surgery

Primary Purpose

Analgesia, Postoperative Pain, Pneumothorax

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Single Port Video-Assisted Thoracoscopic Surgery
Sponsored by
Kyungpook National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. American Society of Anesthesiologists (ASA) physical status 1 or 2
  2. primary spontaneous pneumothorax
  3. elective single port video-assisted thoracoscopic wedge resection of the lung.

Exclusion Criteria:

  1. secondary spontaneous pneumothorax
  2. reoperation in ipsilateral thorax
  3. a history of drug allergy for analgesics
  4. participants who have difficulty understanding the study protocol
  5. refusal of participants

Sites / Locations

  • Kyungpook national university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intercostal Nerve Block

Serratus Anterior Plane Block

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.

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.

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)

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

First Posted
December 4, 2019
Last Updated
December 9, 2019
Sponsor
Kyungpook National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04191850
Brief Title
Ultrasound-Guided Serratus Anterior Plane Block in Pneumothorax Surgery
Official Title
Comparison of the Analgesic Effect Between Ultrasound-Guided Serratus Anterior Plane Block and Intercostal Nerve Block After Single Port Video-Assisted Thoracoscopic Surgery in Primary Spontaneous Pneumothorax
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
January 31, 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 single port video-assisted thoracoscopic surgery with primary spontaneous pneumothorax.
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. Furthermore, single-port thoracoscopic surgery, which reduces the number of surgical incision, is increasingly carried out by many institutions world widely. 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 single port video-assisted thoracoscopic surgeries. 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 primary spontaneous pneumothorax patients who have undergone single port video-assisted thoracoscopic wedge resection. 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, Pneumothorax

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

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.
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.
Intervention Type
Procedure
Intervention Name(s)
Single Port Video-Assisted Thoracoscopic Surgery
Intervention Description
Single Port Video-Assisted Thoracoscopic wedge resection was performed for primary spontaneous pneumothorax.
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
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
After removal of chest tube
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 year
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
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status 1 or 2 primary spontaneous pneumothorax elective single port video-assisted thoracoscopic wedge resection of the lung. Exclusion Criteria: secondary spontaneous pneumothorax reoperation in ipsilateral thorax a history of drug allergy for analgesics participants who have difficulty understanding the study protocol refusal of participants
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 Saeyoung
Phone
+82-53-420-5873
Email
saeyoungkim7@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saeyoung Saeyoung
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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Ultrasound-Guided Serratus Anterior Plane Block in Pneumothorax Surgery

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