Skip to main content
Clinical Trials/NCT04531553
NCT04531553
Completed
Not Applicable

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

National Cancer Institute, Egypt1 site in 1 country90 target enrollmentMarch 3, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-thoracotomy Pain Syndrome
Sponsor
National Cancer Institute, Egypt
Enrollment
90
Locations
1
Primary Endpoint
Pain intensity score
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 3, 2021
End Date
June 15, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Cancer Institute, Egypt
Responsible Party
Principal Investigator
Principal Investigator

Ehab Hanafy Shaker

Assistant professor of Anesthesia, intensive care and pain releif

National Cancer Institute, Egypt

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/m
  • 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.

Outcomes

Primary Outcomes

Pain intensity score

Time Frame: 1 week

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

Secondary Outcomes

  • Number of patients who will develop post-thoracotomy pain syndrome.(3 months)

Study Sites (1)

Loading locations...

Similar Trials