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Efficacy of Bi-level ESPB Application in Patients Undergoing VATS

Primary Purpose

Pain, Postoperative, Thoracic Surgery, Video-Assisted, Erector Spinae Plane Block

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
One-level Erector Spinae Plane Block
Bi-level Erector Spinae Plane Block
Sponsored by
Ankara City Hospital Bilkent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18 and 80 years
  • American Society of Anesthesiologists physical status I-II-III
  • Body mass index between 18-40 kg/m2
  • Patients undergoing elective video-assisted thoracoscopic surgery

Exclusion Criteria:

  • Patient refusing the procedure
  • History of chronic analgesic or opioid therapy
  • History of local anesthetic allergy
  • Infection in the intervention area
  • Emergency surgery

Sites / Locations

  • Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital
  • Ankara City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

One-level Erector Spinae Plane Block

Bi-level Erector Spinae Plane Block

Arm Description

After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T5 spinous process, 30 ml of 0.25% bupivacaine hydrochloride will be injected cauda-cranially into the interfacial space below the erector spinae muscle, above the transverse process.

After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T4 spinous process, 15 ml of 0.25% bupivacaine hydrochloride will be injected cauda-cranially into the interfacial space below the erector spinae muscle, above the transverse process. Next, the needle will be withdrawn till subcutaneously and the linear US probe will be placed 2-3 cm lateral to the T6 spinous process. Finally, 15 ml of 0.25% bupivacaine hydrochloride will be injected cranio-caudally into the interfacial space below the erector spinae muscle, above the transverse process.

Outcomes

Primary Outcome Measures

Pain scores
Pain will be assessed at the first-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain scores
Pain will be assessed at the 2nd-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain scores
Pain will be assessed at the 4th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain scores
Pain will be assessed at the 12th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain scores
Pain will be assessed at the 24th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain scores
Pain will be assessed at the 48th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

Secondary Outcome Measures

Morphine Consumption
Postoperative intravenous morphine infusion therapy will be administered with the patient-controlled analgesia (PCA) method. Thanks to PCA, how much morphine the patient needs will be followed in mg.

Full Information

First Posted
June 16, 2022
Last Updated
February 5, 2023
Sponsor
Ankara City Hospital Bilkent
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1. Study Identification

Unique Protocol Identification Number
NCT05427955
Brief Title
Efficacy of Bi-level ESPB Application in Patients Undergoing VATS
Official Title
Comparison of the Efficiency of Bi-Level ESPB and Single-Level ESPB for Postoperative Analgesia in Patients Undergoing VATS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
December 25, 2022 (Actual)
Study Completion Date
February 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara City Hospital Bilkent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block and erector spina plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased. ESPB is one of them. Although there are publications showing that single-level ESPB applied from the T5 vertebra level spreads in the craniocaudal T3-L2 range, there are also publications stating that the spread is more limited. This study, it was aimed to compare the efficacy of bi-level ESPB application and one-level ESPB application for postoperative analgesia in patients undergoing VATS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Thoracic Surgery, Video-Assisted, Erector Spinae Plane Block, Multimodal Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One-level Erector Spinae Plane Block
Arm Type
Active Comparator
Arm Description
After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T5 spinous process, 30 ml of 0.25% bupivacaine hydrochloride will be injected cauda-cranially into the interfacial space below the erector spinae muscle, above the transverse process.
Arm Title
Bi-level Erector Spinae Plane Block
Arm Type
Active Comparator
Arm Description
After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T4 spinous process, 15 ml of 0.25% bupivacaine hydrochloride will be injected cauda-cranially into the interfacial space below the erector spinae muscle, above the transverse process. Next, the needle will be withdrawn till subcutaneously and the linear US probe will be placed 2-3 cm lateral to the T6 spinous process. Finally, 15 ml of 0.25% bupivacaine hydrochloride will be injected cranio-caudally into the interfacial space below the erector spinae muscle, above the transverse process.
Intervention Type
Procedure
Intervention Name(s)
One-level Erector Spinae Plane Block
Intervention Description
One-level Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the lateral decubitus position. In applications, 30 ml of 0.25% bupivacaine will be injected at the T5 level.
Intervention Type
Procedure
Intervention Name(s)
Bi-level Erector Spinae Plane Block
Intervention Description
Bi-level Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the lateral decubitus position. In applications, 15 ml of 0.25% bupivacaine at T4 level and 15 ml of 0.25% bupivacaine at T6 level will be injected.
Primary Outcome Measure Information:
Title
Pain scores
Description
Pain will be assessed at the first-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Time Frame
1st hour after surgery
Title
Pain scores
Description
Pain will be assessed at the 2nd-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Time Frame
2nd-hour after surgery.
Title
Pain scores
Description
Pain will be assessed at the 4th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Time Frame
4th-hour after surgery.
Title
Pain scores
Description
Pain will be assessed at the 12th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Time Frame
12th-hour after surgery.
Title
Pain scores
Description
Pain will be assessed at the 24th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Time Frame
24th-hour after surgery.
Title
Pain scores
Description
Pain will be assessed at the 48th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Time Frame
48th-hour after surgery.
Secondary Outcome Measure Information:
Title
Morphine Consumption
Description
Postoperative intravenous morphine infusion therapy will be administered with the patient-controlled analgesia (PCA) method. Thanks to PCA, how much morphine the patient needs will be followed in mg.
Time Frame
24 hours after surgery

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: Age between 18 and 80 years American Society of Anesthesiologists physical status I-II-III Body mass index between 18-40 kg/m2 Patients undergoing elective video-assisted thoracoscopic surgery Exclusion Criteria: Patient refusing the procedure History of chronic analgesic or opioid therapy History of local anesthetic allergy Infection in the intervention area Emergency surgery
Facility Information:
Facility Name
Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital
City
Keçiören
State/Province
Ankara
ZIP/Postal Code
06290
Country
Turkey
Facility Name
Ankara City Hospital
City
Çankaya
State/Province
Ankara
ZIP/Postal Code
06290
Country
Turkey

12. IPD Sharing Statement

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Efficacy of Bi-level ESPB Application in Patients Undergoing VATS

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