The Effect of Ultrasound Guided Superficial, Deep Serratus Plane Blocks and Thoracic Epidural in Thoracotomy

NCT04189120 | Completed DMC

• 1 other identifier: AP1811-30102
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Pain after thoracotomy is known to be sever acute pain that is resulted from retraction, resection or fracture of ribs .This pain increases post operative morbidity and if not properly managed peri-operatively, chronic post thoracotomy pain syndrome may develop. Different methods are described to manage post thoracotomy pain.Thoracic epidural analgesia is believed to be the corner stone in the peri-operative care for thoracotomy providing the most effective analgesia. Serratus anterior plane (SAP) block has recently been described as a regional anesthetic technique to provide analgesia for thoracic wall surgeries. During SAP block, local anesthesia are deposited in the fascial plane either superficial to the serratus muscle or deep to the serratus anterior muscle in the mid-axillary line . Serratus anterior block provides analgesia to a hemithorax by blocking the lateral branches of the intercostal nerves. This study aims To compare the effect of superficial, deep serratus plane blocks and thoracic epidural analgesia in maintaining hemodynamic and controlling post thoracotomy pain.

Conditions

Post-thoracotomy Pain Syndrome

Keywords

post thoracotomy pain; thoracic epidural; serratus anterior plane block; ultrasound

Outcome Measures

Primary Outcomes (1)

• changes and stability of Mean Arterial Blood Pressure (MAP).

  Mean arterial blood pressure to be measured after completion of intervention in patients with thoracotomies then every five minutes till the end of surgery.

  every 5 minutes for 3 hours during the surgey

Secondary Outcomes (4)

• Total intra-operative fentanyl consumption

  2-3 hours (Surgery time) surgery

• Pain scores using Visual analogue score

  24 hours after the surgery

• 1st time opioids requested post-operative.

  24 hours after the surgery

• Total morphine consumption.

  24 hours after the surgery

Study Arms (3)

Thoracic epidural analgesia (TEA)

ACTIVE COMPARATOR

Under full aseptic conditions and wearing sterile gloves while the patient is in setting position, skin infiltration will be done with 2 ml of 1% lidocaine, then an 18-G Epidural needle with a 20-G catheter (Perifix, B.Braun, Germany) will be inserted through the T6-T7 interspace, and the epidural space located using the loss of resistance technique. The catheter then advanced approximately 3 cm cephalic. A test dose of 3 ml of 1% lidocaine containing epinephrine in a ratio of 1:200,000 administered to detect unintentional intrathecal or IV injection. After negative response, 15 ml of 0.25% epidural bupivacaine will be injected and the patient will be turned to the supine position.

Procedure: Thoracic epidural analgesia , superficial serratus plane block and deep serratus plane block

Ultrasound-guided superficial serratus plane block (SSPB)

ACTIVE COMPARATOR

Under full aseptic conditions, the patient is placed in lateral position with the diseased side up, sterile field is established with a povidone iodine solution, and the linear transducer 8-12 MH (sonosite M-turbo ; Inc., Bothell, WA, USA) is covered by a disposable sterile cover and will be placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The ribs will be counted until the fifth rib is identified in the mid-axillary line. The muscles will be identified easily overlying the fifth rib, the latissimus dorsi , teres major and serratus muscles . A skin wheal of 1% lidocaine will be made 1 cm away from the lateral edge of the transducer thorough which the needle (22-G, 50-mm Touhy needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus muscle beneath the latissimus dorsi. Under continuous ultrasound guidance 30 ml of 0.25% bupivacaine will be injected

Procedure: Thoracic epidural analgesia , superficial serratus plane block and deep serratus plane block

Ultrasound-guided deep serratus plane block (DSPB)

ACTIVE COMPARATOR

Under full aseptic conditions, the patient is placed in lateral position with the diseased side up, sterile field is established with a povidone iodine solution, and the linear transducer 8-12 MH (sonosite M-turbo ; Inc., Bothell, WA, USA) is covered by a disposable sterile cover and will be placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The ribs will be counted until the fifth rib is identified in the mid-axillary line. A skin wheal of 1% lidocaine will be made 1 cm away from the lateral edge of the transducer thorough which the needle (22-G, 50-mm Touhy needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane between the posterior border of the serratus anterior muscle and the corresponding surface of the rib. Under continuous ultrasound guidance 30 ml of 0.25% bupivacaine will be injected deep to the serratus muscle separating the serratus anterior muscle from the external intercostal muscle.

Procedure: Thoracic epidural analgesia , superficial serratus plane block and deep serratus plane block

Interventions

Thoracic epidural analgesia , superficial serratus plane block and deep serratus plane block PROCEDURE

neuroaxial thoracic epidural analgesia and regional analgesia supeficial and deep serratus plane blocks

Thoracic epidural analgesia (TEA); Ultrasound-guided deep serratus plane block (DSPB); Ultrasound-guided superficial serratus plane block (SSPB)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA(American Society of Anesthesia) class I and II.
• Age ≥ 18 and ≤ 60 Years.
• Patients undergoing thoracic surgery eg: lobectomy, pneumonectomy or pleuro-pneumonectomy

You may not qualify if:

• Patient refusal.
• Local infection at the puncture site.
• Coagulopathy with INR ( international normalized ratio ) ≥ 1.6: hereditary (e.g. hemophilia, fibrinogen abnormalities \& deficiency of factor II) - acquired (e.g. impaired liver functions with prothrombin concentration less than 60 %, vitamin K deficiency \& therapeutic anticoagulants drugs).
• Unstable cardiovascular disease.
• History of psychiatric and cognitive disorders.
• Patients allergic to medication used.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute - Cairo University

Cairo, 11796, Egypt

Location

Related Publications (2)

• Khalil AE, Abdallah NM, Bashandy GM, Kaddah TA. Ultrasound-Guided Serratus Anterior Plane Block Versus Thoracic Epidural Analgesia for Thoracotomy Pain. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):152-158. doi: 10.1053/j.jvca.2016.08.023. Epub 2016 Aug 21.

  PMID: 27939192 BACKGROUND

• Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.

  PMID: 23923989 BACKGROUND

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ekramy Mansour, MD

  National Cancer Institute - Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: December 6, 2019
• Study Start: April 1, 2019
• Primary Completion: May 15, 2021
• Study Completion: May 16, 2021
• Last Updated: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)