Clinical trial NCT04531553: Erector Spinae Plane Block for Post-thoracotomy Pain Control
Official title: The Impact of Ultrasound-Guided Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in the Management of Acute and Chronic Post-Thoracotomy Pain: A Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-thoracotomy Pain Syndrome
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: The thoracic epidural block (TEB) and thoracic paravertebral block (TPVB) are the most commonly used techniques for analgesia after thoracic surgery. However, TEA has several adverse effects, such as hypotension, motor blockade, hematoma, and abscess and TPVB has a chance of epidural spread and pneumothorax, and multiple injections are needed if more than 4 dermatome analgesia is required. Recently, erector spinae plane block (ESPB) was reported as a treatment for thoracic neuropathic pain.

ESPB is a relatively simple technique with easily identified sonographic landmarks, and a catheter is easily inserted into the plane after distention induced by the injection. Additionally, the ESPB has the potential to provide both somatic and visceral sensory blockade.

The selectivity of dexmedetomidine to the α2-receptors is eight times of its prototype, clonidine. Accordingly, dexmedetomidine is a more powerful sedative and analgesic drug than clonidine with less hemodynamic derangements from the α1-receptor activation. 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. Previous studies have declared that dexmedetomidine potentiates local anesthetic effect when administered by neuroaxial route.

This study aims to evaluate the effect ultrasound erector spinae plane block with dexmedetomidine infusion in management of acute and chronic post thoracotomy pain.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain intensity score
timeFrame: 1 week
Secondary outcomes:
measure: Number of patients who will develop post-thoracotomy pain syndrome.
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Anesthesia and Pain medicine.National Cancer Institute
Study officials:
affiliation: Assistant Professor of Anesthesia, intensive care and pain releif
name: Ehab H Gendy, MD
role: PRINCIPAL_INVESTIGATOR
References: