Erector Spinae Plane Block for Post-thoracotomy Pain Control

NCT04531553 | Completed

• 1 other identifier: ESPB for PTPS
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The thoracic epidural block (TEB) and thoracic paravertebral block (TPVB) are the most commonly used techniques for analgesia after thoracic surgery.Recently, erector spinae plane block (ESPB) was reported as a treatment for thoracic neuropathic pain.Dexmedetomidine has been primarily used for intra- venous sedation in intensive care settings. The unique analgesic properties of dexmedetomidine have encouraged the anesthesiologists to use it perineurally. This study aims to evaluate the effect ultrasound erector spinae plane block with dexmedetomidine infusion in management of acute and chronic post thoracotomy pain.

Conditions

Post-thoracotomy Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Pain intensity score

  measurement of Visual analogue score in a line 0 to 100 , where 0 indicates no pain and 100 indicates the worst pain.

  1 week

Secondary Outcomes (1)

• Number of patients who will develop post-thoracotomy pain syndrome.

  3 months

Study Arms (3)

Thoracic epidural analgesia

ACTIVE COMPARATOR

Patients will preoperatively receive thoracic epidural at the level T5 \& T6 with bolus 20 ml of levobupivacaine 0.25% then levobupivacaine 0.1% infused at a rate of 0.1 mL/Kg/h until chest tube removal ( 5-6 days).

Procedure: Thoracic epidural analgesia

ESPB with levobupivacaine

ACTIVE COMPARATOR

patients will preoperatively receive US guided ESP block on the side to be operates upon, the puncture point of the skin is infiltrated with 2% lidocaine, and once the structures are identified with ultrasound at the level of T5 transverse process, we will inject bolus 20ml of levobupivacaine 0.25% on the deep aspect of erector spinae muscle then catheter inserted.A 20 ml bolus of levobupivacaine 0.1% is injected every 6 hours until chest tube removal.

Procedure: ESPB with levobupivacaine

ESPB with levobupivacaine and dexmedetomidine

ACTIVE COMPARATOR

patients will preoperatively receive US guided ESP block on the side to be operates upon, the puncture point of the skin is infiltrated with 2% lidocaine, and once the structures are identified with ultrasound at the level of T5 transverse process, we will inject bolus 20ml of levobupivacaine 0.25% plus 0.5mic/Kg dexmedetomidine on the deep aspect of erector spinae muscle then catheter inserted. 20 ml bolus of levobupivacaine 0.1% with dexmedetomidine 0.5 μg/Kg was injected every 6 hours until chest tube removal.

Procedure: ESPB with levobupivacaine and dexmedetomedine

Interventions

Thoracic epidural analgesia PROCEDURE

Patients will preoperatively receive thoracic epidural at the level T5 \& T6 with bolus 20 ml of levobupivacaine 0.25% then levobupivacaine 0.1% infused at a rate of 0.1 mL/Kg/hr until chest tube removal ( 5-6 days).

Thoracic epidural analgesia

ESPB with levobupivacaine and dexmedetomedine PROCEDURE

patients will preoperatively receive US guided ESP block on the side to be operates upon, the puncture point of the skin is infiltrated with 2% lidocaine, and once the structures are identified with ultrasound at the level of T5 transverse process, we will inject bolus 20ml of levobupivacaine 0.25% plus 0.5mic/Kg dexmedetomidine on the deep aspect of erector spinae muscle then catheter inserted. 20 ml bolus of levobupivacaine 0.1% with dexmedetomidine 0.5 μg/Kg was injected every 6 hours until chest tube removal.

ESPB with levobupivacaine and dexmedetomidine

ESPB with levobupivacaine PROCEDURE

patients will preoperatively receive US guided ESP block on the side to be operates upon, the puncture point of the skin is infiltrated with 2% lidocaine, and once the structures are identified with ultrasound at the level of T5 transverse process, we will inject bolus 20ml of levobupivacaine 0.25% on the deep aspect of erector spinae muscle then catheter inserted.A 20 ml bolus of levobupivacaine 0.1% is injected every 6 hours until chest tube removal.

ESPB with levobupivacaine

Eligibility Criteria

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

You may qualify if:

• Physical status ASA I and II.
• Age ≥ 18 and ≤ 65 Years.
• Body mass index (BMI): \> 20 kg/m2 and \< 40 kg/m2.
• Patient undergoing thoracotomy for cancer surgery (Lobectomy, Pneumonectomy, and Decortication).

You may not qualify if:

• Patient refusal
• Known sensitivity or contraindication to local anesthetics or dexmedetomidine.
• History of psychological disorders.
• Localized infection at the site of block.
• Coagulopathies with platelet count below 50,000 or an INR\>1.5.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Department of Anesthesia and Pain medicine.National Cancer Institute

Cairo, 11796, Egypt

Location

MeSH Terms

Interventions

Tea; Levobupivacaine

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ehab H Gendy, MD

  Assistant Professor of Anesthesia, intensive care and pain releif

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anesthesia, intensive care and pain releif

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Study Start: March 3, 2021
• Primary Completion: May 28, 2022
• Study Completion: June 15, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)