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Postoperative Analgesia y After Uniportal Video-assisted Thoracoscopic Surgery

Primary Purpose

Post-operative Pain, Acute, Post-operative Pain, Thoracic Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ultrasound-guided erector spinae plane block
surgical thoracoscopic intercostal nerve block
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain, Acute focused on measuring Uniportal video-assisted thoracoscopic surgery, Ultrasound-guided erector spinae plane block, surgical thoracoscopic intercostal nerve block, cumulative intravenous morphine consumption, visual analogue scale, Enhanced Recovery After Surgery

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult patients, over 20 years old, u
  • undergoing elective uniportal VATS lobectomy.

Exclusion Criteria:

  • patient refusal,
  • body mass index > 35 kg/m2,
  • American society of anesthesiologists (ASA) grade above 3,
  • contraindication to nerve block,
  • allergy to analgesic agents,
  • regular opioid used for chronic pain prior to this time surgery,
  • conversion to thoracotomy or VATS procedure,
  • postoperative intubation,
  • postoperative intensive care unit admission.

Sites / Locations

  • National Cheng Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

post-operative VAS score of Ultrasound-guided erector spinae plane block

post-operative VAS score of surgical thoracoscopic intercostal nerve block

Arm Description

Outcomes

Primary Outcome Measures

Visual analogue scale
post-op VAS score, 0-10, the higher means painful, and "0" point no pain.
accumulated morphine usage dose
accumulated morphine usage dose

Secondary Outcome Measures

Full Information

First Posted
January 26, 2022
Last Updated
February 23, 2023
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05242328
Brief Title
Postoperative Analgesia y After Uniportal Video-assisted Thoracoscopic Surgery
Official Title
Comparison of Surgical Thoracoscopic Intercostal Nerve Block and Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia and Enhanced Recovery After Uniportal Video-assisted Thoracoscopic Surgery: a Double-blinded, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
December 26, 2024 (Anticipated)
Study Completion Date
December 26, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Ultrasound-guided erector spinae plane block (ESPB) is an interfascial blockade during thoracic anesthesia, first described by Forero in 2016, and is highlighted by technically feasibility and less complication rate. The patient is placed as decubitus position. The anesthesiologists use echo to identify the ipsilateral transverse process at T5 level, and insert the needle to 2-3 cm lateral to the spinous process until contact the transverse process. Then the injected local anesthetic will penetrate via erector spinae muscle to paravertebral space to affect and relieve pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain, Acute, Post-operative Pain, Thoracic Diseases, Post-Op Complication
Keywords
Uniportal video-assisted thoracoscopic surgery, Ultrasound-guided erector spinae plane block, surgical thoracoscopic intercostal nerve block, cumulative intravenous morphine consumption, visual analogue scale, Enhanced Recovery After Surgery

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
post-operative VAS score of Ultrasound-guided erector spinae plane block
Arm Type
Active Comparator
Arm Title
post-operative VAS score of surgical thoracoscopic intercostal nerve block
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided erector spinae plane block
Intervention Description
Ultrasound-guided erector spinae plane block
Intervention Type
Procedure
Intervention Name(s)
surgical thoracoscopic intercostal nerve block
Intervention Description
surgical thoracoscopic intercostal nerve block
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
post-op VAS score, 0-10, the higher means painful, and "0" point no pain.
Time Frame
post-op 2 days
Title
accumulated morphine usage dose
Description
accumulated morphine usage dose
Time Frame
post-op 2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients, over 20 years old, u undergoing elective uniportal VATS lobectomy. Exclusion Criteria: patient refusal, body mass index > 35 kg/m2, American society of anesthesiologists (ASA) grade above 3, contraindication to nerve block, allergy to analgesic agents, regular opioid used for chronic pain prior to this time surgery, conversion to thoracotomy or VATS procedure, postoperative intubation, postoperative intensive care unit admission.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuoying Dai, MD
Phone
+886-6-2353535
Ext
5182
Email
hsnu_10@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuoying Dai
Organizational Affiliation
National Cheng-Kung University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuoying Dai, MD
Phone
+886-6-2353535
Ext
5182
Email
hsnu_10@yahoo.com.te

12. IPD Sharing Statement

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Postoperative Analgesia y After Uniportal Video-assisted Thoracoscopic Surgery

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