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

Evaluation of the Ultrasound-guided Erector Spinae Plane Block Using Catheter for Postoperative Analgesia in Video-assisted Thoracoscopy: A Prospective, Randomized, Controlled Clinical Trial

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Opioid Use; Post Operative Pain
• Intervention / Treatment: Procedure: Erector spinae plane block catheter

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.

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anwar ul Huda, FRCA; Phone Number: 00966118024331; Email: hudaanwar90@yahoo.com
• Study Contact Backup: Name: Elsadig Ezat, MBBS; Phone Number: 00966535755004; Email: Eezat@sfh.med.sa

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Security Forces Hospital Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ESPB catheter group; Patient in this group will receive ESP block	Procedure: Erector spinae plane block catheter; 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.
No Intervention: Control group; Patient in this group will not receive any block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 hours opioid consumption	How much opioid (morphine equivalents) in milligrams was consumed in 24 hours after surgery	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	first 24 hours
Postoperative nausea and vomiting	The incidence and severity of postoperative nausea and vomiting	24 hours
Postoperative shoulder pain	Any complaint of Pain in shoulder in postoperative period will be recorded	24 hours

Collaborators and Investigators

• Sponsor: Security Forces Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: March 12, 2022
• First Submitted That Met QC Criteria: April 16, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 16, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: erector spinae block; Video-assisted thoracoscopy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: SFH-ESPB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: It will be provided on request
• IPD Sharing Time Frame: 2 months
• IPD Sharing Access Criteria: On request
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• 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