Impact of Thoracic Epidural Versus Serratus Anterior Plane Block Versus Erector Spinae Plane Block on Incidence of PTPS

NCT05409144 | Unknown

• 1 other identifier: AP2202-30106
• Study Type: interventional
• Target: 111
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to evaluate the impact of Ultrasound-guided Erector Spinae plane block compared to Ultrasound-guided serratus anterior plane block on the emergence of post-thoracotomy pain syndrome in patients undergoing lobectomy for lung cancer.

Conditions

Post-thoracotomy Pain Syndrome; Erector Spinae Plane Block; Serratus Anterior Plane Block

Outcome Measures

Primary Outcomes (1)

• Incidence of patients developing post-thoracotomy pain syndrome

  The incidence of patients developing post-thoracotomy pain syndrome according to grading system for neuropathic pain (GSNP

  12 weeks postoperatively

Secondary Outcomes (11)

• Morphine consumption

  48 hours Postoperatively

• Fentanyl consumption

  Intraoperatively

• Post-thoracotomy pain syndrome severity

  12 weeks postoperatively

• Patient's Quality of life

  12 weeks postoperatively

• Postoperative Patient's activity level

  12 weeks postoperatively

Study Arms (3)

Thoracic epidural infusion group

EXPERIMENTAL

Patients will receive thoracic epidural preoperative

Procedure: Thoracic epidural infusion

Erector Spinae Plane Block group

EXPERIMENTAL

Patients will receive Ultrasound-guided Erector Spinae Plane Block preoperative with an injection of 30 ml levobupivacaine 0.25% and insertion of a catheter

Device: Erector Spinae Plane Block

Serratus Anterior Plane Block group

EXPERIMENTAL

Patients will receive Ultrasound-guided Serratus Anterior Plane Block preoperative with an injection of 30 ml levobupivacaine 0.25%.

Device: Serratus Anterior Plane Block

Interventions

Thoracic epidural infusion PROCEDURE

Upon locating the desired site spot, lidocaine 1% must be injected into the skin and underlying tissues to decrease the discomfort with the advancement of the epidural needle. Once achieving local anesthesia, the epidural needle advanced with its stylet in place and with its bevel point cephalad; this will ultimately contribute to the proper location of the epidural catheter. The epidural needle must be advanced through the skin, subcutaneous tissue, supraspinous, and interspinous ligaments. Once there, the stylet must be removed, and the Loss of Resistance syringe (filled up with saline, air, or both) must be attached to the needle. The needle must be advanced while applying pressure to the plunger. Once the ligamentum flavum is pierced, a loss in resistance will be noted; this is the epidural space, and 5 to 10 cc of saline is injected to expand the epidural space; this may decrease the risk of vascular injury.

Thoracic epidural infusion group

Erector Spinae Plane Block DEVICE

The block-level will be at T5. The ultrasound probe will be placed on the back in a transverse orientation to identify the tip of the T5 transverse process; these are recognizable as flat, squared-off acoustic shadows with only a very faint image of the pleura visible. The tip of the transverse process will be centered on the ultrasound screen and the probe will then be rotated into a longitudinal orientation to produce a parasagittal view, in which the following layers will be visible superficial to the acoustic shadows of the transverse processes: skin and subcutaneous tissue, trapezius, erector spinae muscle and T5 transverse process. 3ml lidocaine 1% will be used on skin and subcutaneous fat, Echogenic block needle will be inserted in-plane to the ultrasound beam in a cranial-to-caudal direction until contact is made with the T5 transverse process.

Erector Spinae Plane Block group

Serratus Anterior Plane Block DEVICE

The block is performed with full aseptic precautions. Arm abduction is preferred. The ultrasound probe will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, with the indicator oriented toward the operator's left. With the rib, pleural line, and overlying serratus anterior and latissimus dorsi muscles visualized, then, 3ml lidocaine 1% will be used for skin and subcutaneous fat, using ultrasound guidance, a 38-mm 22-gauge regional block needle is going to be advanced in-plane at an angle of approximately 45 degrees towards the fifth rib. After aspiration to avoid intravascular injection 30ml of levobupivacaine 0.25% will be injected anteriorly to the rib and deep into the serratus anterior muscle.

Serratus Anterior Plane Block group

Eligibility Criteria

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

You may qualify if:

• Age (18-65) Years
• Physical status American Society of Anesthesiologists Classification II, III
• Patients undergoing lobectomy through lateral thoracotomy
• Body mass index (BMI): (20-40) kg/m2

You may not qualify if:

• Patient refusal.
• Age \<18 years or \>65 years
• Body mass index (BMI) \<20 kg/m2 and \>40 kg/m2
• Known sensitivity or contraindication to drugs used in the study
• Contraindication to regional anesthesia e.g. local infection at site of introduction, pre-existing peripheral neuropathies and coagulopathy.
• Pregnancy.
• Physical status American Society of Anesthesiologists Classification IV
• patients on chronic analgesic therapy (daily morphine ≥30 mg or equivalent dose of other opioids or tramadol or any medication for neuropathic pain)
• patients with a history of drug abuse
• patients with neuropsychiatric diseases; patients with a history of chronic pain syndromes that may enhance sensitivity to pain, for example, fibromyalgia
• patients with a history of thoracic surgery through lateral thoracotomy; and patients with recurrent chest malignancies within 3 months.
• All patients who developed severe intra- or post-operative bleeding or required postoperative mechanical ventilation were also excluded from the study.
• Thoracic spine disorders or deformity.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Central Study Contacts

Ahmed Abdelfattah, M.Sc

CONTACT

1222332541; Dr.ahmed.sha3ban@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant lecturer

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 8, 2022
• Study Start: June 20, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the study is ended