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Erector Spinae Plane Block for Post-thoracotomy Pain Control

N

National Cancer Institute, Egypt

Status

Completed

Conditions

Post-thoracotomy Pain Syndrome

Treatments

Procedure: ESPB with levobupivacaine
Procedure: Thoracic epidural analgesia
Procedure: ESPB with levobupivacaine and dexmedetomedine

Study type

Interventional

Funder types

Other

Identifiers

NCT04531553
ESPB for PTPS

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 3 patient groups

Thoracic epidural analgesia
Active Comparator group
Description:
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).
Treatment:
Procedure: Thoracic epidural analgesia
ESPB with levobupivacaine
Active Comparator group
Description:
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.
Treatment:
Procedure: ESPB with levobupivacaine
ESPB with levobupivacaine and dexmedetomidine
Active Comparator group
Description:
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.
Treatment:
Procedure: ESPB with levobupivacaine and dexmedetomedine

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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