Erector Spinae Plane Block Versus Thoracic Epidural Block for Chest Trauma

NCT03797079 | Completed

• 1 other identifier: ESP Block for Chest Trauma
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Rib fractures are very common as a consequence of blunt chest trauma which is associated with severe pain, morbidity and mortality. The key to managing these patients is prompt and effective analgesia, early mobilization, respiratory support, with chest physiotherapy. The aim of this study is to compare and evaluate the differences between either continuous erector spinae plane (ESP) block, or thoracic epidural analgesia (TEA) as analgesic modalities in patients with chest trauma. It is hypothesized that ESP block will be comparable to TEA as a promising effective analgesic alternative with fewer side effects.

Conditions

Chest Trauma

Keywords

Erector spinae plane block

Outcome Measures

Primary Outcomes (1)

• Improvement in pain scores by Visual analogue scale (VAS)

  VAS score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) will be assessed every two hours for 48 hours after the procedure.

  Up to 48 hours after the procedure

Secondary Outcomes (10)

• Total analgesic requirements of fentanyl

  Up to 48 hours after the procedure

• First analgesic request

  Up to 48 hours after the procedure

• Changes in heart rate (HR)

  Up to 48 hours after the procedure

• Changes in mean arterial blood pressure (MAP)

  Up to 48 hours after the procedure

• Improvement in forced expiratory volume in one second (FEV1)

  Up to 48 hours after the procedure

Study Arms (2)

Group A (ESP block)

ACTIVE COMPARATOR

Ultrasound-guided ESP block will be performed under strict aseptic precautions with patient in the sitting position. Catheter insertion will be performed and bupivacaine will be administered.

Procedure: ESP block; Device: Catheter insertion; Drug: Bupivacaine

Group B (TEA)

ACTIVE COMPARATOR

TEA will be performed under strict aseptic precautions with patient in the sitting position. Catheter insertion will be performed and bupivacaine will be administered.

Procedure: TEA; Device: Catheter insertion; Drug: Bupivacaine

Interventions

ESP block PROCEDURE

A high-frequency linear ultrasound probe will be placed superficial to erector spinae muscle (ESM) in a parasagittal plane 3 cm lateral to the midline at the level of fifth thoracic vertebra. Three muscles will be identified superficial to the hyperechoic transverse process shadow: trapezius (uppermost), rhomboids major (middle), and ESM (lowermost). After local infiltration of skin and using in-plane approach, an 18 G Tuohy needle will be inserted, until the tip lay between the rhomboid major muscle and ESM.

Group A (ESP block)

TEA PROCEDURE

Skin will be locally infiltrated at the site of needle insertion, and 18 G Tuohy needle will be introduced until its tip lay in the epidural space of the T5-T6 thoracic intervertebral space.

Group B (TEA)

Catheter insertion DEVICE

After obtaining loss of resistance, 20 G epidural catheter will be threaded for 5 cm and then fixed on the skin.

Group A (ESP block); Group B (TEA)

Bupivacaine DRUG

After the negative aspiration for blood, a bolus dose of 15 ml 0.125% plain bupivacaine will be injected in the catheter, followed by a continuous infusion of 0.25% plain bupivacaine at the rate of 0.1 ml/kg/h for 48 hours

Also known as: Marcaine

Group A (ESP block); Group B (TEA)

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologists (ASA) status: 1 or 2 .
• Blunt chest trauma.
• Multiple rib fractures.
• Flail chest.
• Lung contusions.

You may not qualify if:

• Bilateral chest trauma.
• Intubated patients.
• Other peripheral or abdominal injuries.
• Traumatic brain injury, altered mental status or un-cooperative patients.
• Acute spine fractures or pre-existing spine deformity.
• Unstable hemodynamics.
• Sensitivity to local anesthetic drugs.
• Coagulation abnormalities.
• Infection at the site of procedure.
• Significant cardiac or respiratory dysfunction, hepatic or renal impairment.

Sponsors & Collaborators

• Sameh Fathy: lead

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Related Publications (8)

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• Gage A, Rivara F, Wang J, Jurkovich GJ, Arbabi S. The effect of epidural placement in patients after blunt thoracic trauma. J Trauma Acute Care Surg. 2014 Jan;76(1):39-45; discussion 45-6. doi: 10.1097/TA.0b013e3182ab1b08.

  PMID: 24368355 BACKGROUND

• Galvagno SM Jr, Smith CE, Varon AJ, Hasenboehler EA, Sultan S, Shaefer G, To KB, Fox AD, Alley DE, Ditillo M, Joseph BA, Robinson BR, Haut ER. Pain management for blunt thoracic trauma: A joint practice management guideline from the Eastern Association for the Surgery of Trauma and Trauma Anesthesiology Society. J Trauma Acute Care Surg. 2016 Nov;81(5):936-951. doi: 10.1097/TA.0000000000001209.

  PMID: 27533913 BACKGROUND

• Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.

  PMID: 30052229 BACKGROUND

• Singh S, Jacob M, Hasnain S, Krishnakumar M. Comparison between continuous thoracic epidural block and continuous thoracic paravertebral block in the management of thoracic trauma. Med J Armed Forces India. 2017 Apr;73(2):146-151. doi: 10.1016/j.mjafi.2016.11.005. Epub 2016 Dec 24.

  PMID: 28924315 BACKGROUND

• Veiga M, Costa D, Brazao I. Erector spinae plane block for radical mastectomy: A new indication? Rev Esp Anestesiol Reanim (Engl Ed). 2018 Feb;65(2):112-115. doi: 10.1016/j.redar.2017.08.004. Epub 2017 Nov 2. English, Spanish.

  PMID: 29102405 BACKGROUND

• Witt CE, Bulger EM. Comprehensive approach to the management of the patient with multiple rib fractures: a review and introduction of a bundled rib fracture management protocol. Trauma Surg Acute Care Open. 2017 Jan 5;2(1):e000064. doi: 10.1136/tsaco-2016-000064. eCollection 2017.

  PMID: 29766081 BACKGROUND

• Yeh DD, Kutcher ME, Knudson MM, Tang JF. Epidural analgesia for blunt thoracic injury--which patients benefit most? Injury. 2012 Oct;43(10):1667-71. doi: 10.1016/j.injury.2012.05.022. Epub 2012 Jun 16.

  PMID: 22704784 BACKGROUND

MeSH Terms

Conditions

Thoracic Injuries

Interventions

Tea; Catheterization; Bupivacaine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Therapeutics; Investigative Techniques; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sameh M El-Sherbiny, MD

  Faculty of Medicine, Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study subjects and the resident assessing the outcomes will be blinded to the study group. A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation, perform the block, and administer bupivacaine solution.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Model Details: Prospective, randomized, double blind study

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 8, 2019
• Study Start: January 20, 2019
• Primary Completion: February 20, 2020
• Study Completion: April 20, 2020
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)