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Ultrasound-guided Erector Spinae Plane Block Using Catheter for Video-assisted Thoracoscopy

Primary Purpose

Post Operative Pain, Opioid Use

Status
Not yet recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Erector spinae plane block catheter
Sponsored by
Security Forces Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring erector spinae block, Video-assisted thoracoscopy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients aged 18-70 years, ASA 1 to 3 undergoing video-assisted thoracoscopy

Exclusion Criteria:

  • Patient refusal, Contraindication to regional anesthesia, Allergy to local anesthesia, bleeding diathesis, use of anticoagulants or corticosteroids, inability to operate PCA, psychiatric disorders or use of psychiatric medications, conversion to open thoracotomy

Sites / Locations

  • Security Forces Hospital Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

ESPB catheter group

Control group

Arm Description

Patient in this group will receive ESP block

Patient in this group will not receive any block

Outcomes

Primary Outcome Measures

24 hours opioid consumption
How much opioid (morphine equivalents) in milligrams was consumed in 24 hours after surgery

Secondary Outcome Measures

Numerical rating score (NRS) pain score at 15 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours after surgery both at rest and when coughing
Pain score measure by NRS pain score in postoperative period
Postoperative nausea and vomiting
The incidence and severity of postoperative nausea and vomiting
Postoperative shoulder pain
Any complaint of Pain in shoulder in postoperative period will be recorded

Full Information

First Posted
March 12, 2022
Last Updated
April 16, 2022
Sponsor
Security Forces Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05337956
Brief Title
Ultrasound-guided Erector Spinae Plane Block Using Catheter for Video-assisted Thoracoscopy
Official Title
Evaluation of the Ultrasound-guided Erector Spinae Plane Block Using Catheter for Postoperative Analgesia in Video-assisted Thoracoscopy: A Prospective, Randomized, Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Security Forces 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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Different modalities ranging from patient controlled analgesia (PCA) to different regional blocks have been used to control postoperative pain after thoracic surgeries. Thoracic epidural analgesia and paravertebral blocks are effective modes of pain relief but have the risks of severe complications and side effects which include severe hypotension, nerve injury or spinal cord injury, vascular injury and pleural injury etc. Erector spinae plane block (ESPB) is relatively new regional technique which was described by Forero et al in 2016. Several studies have demonstrated an effective role of ESPB in controlling pain for thoraco-abdominal surgeries which include breast surgery, thoracic surgery and upper GI laparoscopy. Shim et al in their study showed that ESPB significantly reduced pain score in first 6 hours postoperatively in patients who underwent VATS. The aim of this study is to evaluate the effect of ESPB using catheter on postoperative 24 hours opioid consumption in video-assisted thoracoscopy (VATS)
Detailed Description
Video-assisted thoracoscopic surgery (VATS) is more commonly used technique nowadays in thoracic surgery. This technique is associated with lesser postoperative pain, better postoperative pulmonary function, decreased mortality and shorter hospital stay. However, patients can have severe and prolonged postoperative pain following VATS. Homma et al reported that 18.8 % of patients have persistent pain following VATS. Acute postoperative pain is considered to be one of strong predictor of persistent pain postoperatively. Different modalities ranging from patient controlled analgesia (PCA) to different regional blocks have been used to control postoperative pain after thoracic surgeries. Thoracic epidural analgesia and paravertebral blocks are effective modes of pain relief but have the risks of severe complications and side effects which include severe hypotension, nerve injury or spinal cord injury, vascular injury and pleural injury etc. Erector spinae plane block (ESPB) is relatively new regional technique which was described by Forero et al in 2016. Several studies have demonstrated an effective role of ESPB in controlling pain for thoraco-abdominal surgeries which include breast surgery, thoracic surgery and upper GI laparoscopy. Shim et al in their study showed that ESPB significantly reduced pain score in first 6 hours postoperatively in patients who underwent VATS. The objective of this study is to investigate the role of ESPB using catheter in reducing opioid requirements in first 24 hours after VATS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Opioid Use
Keywords
erector spinae block, Video-assisted thoracoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESPB catheter group
Arm Type
Active Comparator
Arm Description
Patient in this group will receive ESP block
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patient in this group will not receive any block
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block catheter
Intervention Description
All ESP blocks will be performed in lateral position after general anesthesia induction. ESPB will be performed under ultrasonographic guidance using a linear 6- to 10-MHz ultrasound probe. The linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the T6-10 spinous process. The erector spinae muscles will be identified superficial to the tip of the transverse process. A 21-gauge 10-cm needle will be inserted using an in-plane superior-to-inferior approach or an out of plane approach. The tip of the needle will be placed into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process on Ultrasonographic imaging. A total of 10-15 ml of 0.2% ropivacaine will be injected each side. A catheter will then be placed leaving 5 cm in place.
Primary Outcome Measure Information:
Title
24 hours opioid consumption
Description
How much opioid (morphine equivalents) in milligrams was consumed in 24 hours after surgery
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Numerical rating score (NRS) pain score at 15 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours after surgery both at rest and when coughing
Description
Pain score measure by NRS pain score in postoperative period
Time Frame
first 24 hours
Title
Postoperative nausea and vomiting
Description
The incidence and severity of postoperative nausea and vomiting
Time Frame
24 hours
Title
Postoperative shoulder pain
Description
Any complaint of Pain in shoulder in postoperative period will be recorded
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients aged 18-70 years, ASA 1 to 3 undergoing video-assisted thoracoscopy Exclusion Criteria: Patient refusal, Contraindication to regional anesthesia, Allergy to local anesthesia, bleeding diathesis, use of anticoagulants or corticosteroids, inability to operate PCA, psychiatric disorders or use of psychiatric medications, conversion to open thoracotomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anwar ul Huda, FRCA
Phone
00966118024331
Email
hudaanwar90@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elsadig Ezat, MBBS
Phone
00966535755004
Email
Eezat@sfh.med.sa
Facility Information:
Facility Name
Security Forces Hospital Program
City
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
It will be provided on request
IPD Sharing Time Frame
2 months
IPD Sharing Access Criteria
On request

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Ultrasound-guided Erector Spinae Plane Block Using Catheter for Video-assisted Thoracoscopy

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