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

NCT05337956 | Unknown DMC

• 1 other identifier: SFH-ESPB
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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)

Conditions

Post Operative Pain; Opioid Use

Keywords

erector spinae block; Video-assisted thoracoscopy

Outcome Measures

Primary Outcomes (1)

• 24 hours opioid consumption

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

  24 hours

Secondary Outcomes (3)

• 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

  first 24 hours

• Postoperative nausea and vomiting

  24 hours

• Postoperative shoulder pain

  24 hours

Study Arms (2)

ESPB catheter group

ACTIVE COMPARATOR

Patient in this group will receive ESP block

Procedure: Erector spinae plane block catheter

Control group

NO INTERVENTION

Patient in this group will not receive any block

Interventions

Erector spinae plane block catheter PROCEDURE

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.

ESPB catheter group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Security Forces Hospital: lead

Study Sites (1)

Security Forces Hospital Program

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Anwar ul Huda, FRCA

CONTACT

00966118024331; hudaanwar90@yahoo.com

Elsadig Ezat, MBBS

CONTACT

00966535755004; Eezat@sfh.med.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anesthesia

Study Record Dates

• First Submitted: March 12, 2022
• First Posted: April 20, 2022
• Study Start: April 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2 months
• Access Criteria: On request

Locations

SA (1)