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Clinical Trials/NCT05507281
NCT05507281
Completed
Not Applicable

Efficacy of Ultrasound-guided Erector Spinae Plane Block Versus Retrolaminar Block for Postoperative Analgesia in Patients Undergoing Thoracotomy

Tanta University1 site in 1 country60 target enrollmentAugust 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Analgesia
Sponsor
Tanta University
Enrollment
60
Locations
1
Primary Endpoint
Pain assessment
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Comparing efficacy of Ultrasound-guided Erector Spinae Plane Block versus Retrolaminar Block for Postoperative Analgesia in Patients Undergoing Thoracotomy

Detailed Description

Thoracotomy is one of the most painful surgical procedures. The reported incidence of persistent pain after thoracic surgery (post thoracotomy pain syndrome) has been reported in 20%-70% of patients. Inadequately treated post thoracotomy pain can have several negative consequences. Therefore, pain relief is essential to facilitate coughing and deep breathing and to promote early mobilization. Thoracic epidural analgesia and thoracic paravertebral block are strongly recommended techniques for managing post thoracotomy pain to reduce opioid use and the related adverse effects as hypoventilation, depression of cough reflex, nausea and vomiting. However, they can be technically challenging to perform and are associated with up to 15% failure rate in Thoracic epidural analgesia and potential risk of pneumothorax in thoracic paravertebral block. Erector spinae plane block is a relatively novel ultrasound-guided regional technique. Its application in patients with chronic thoracic neuropathic pain and acute surgical pain has been described by Forero et al. Retrolaminar block is an easy and safe analgesic technique. It has been reported to be satisfactory for post-operative analgesia after breast surgery. To our knowledge there is no clinical studies, comparing the effectiveness of both blocks on postthoracotomy pain, has been reported.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
August 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fatma Adel Momen Elshazly

Principal Investigator

Tanta University

Eligibility Criteria

Inclusion Criteria

  • Adult patients aged 21-65 years old of both sexes.
  • Patients were scheduled for elective thoracotomy.
  • Their ASA physical status classification is II-III.

Exclusion Criteria

  • Patients' refusal.
  • Local infection at the site of block.
  • Coagulation abnormalities.
  • Sever spinal deformity e.g. scoliosis.
  • Known hypersensitivity to local anesthetics.
  • Mental dysfunction and cognitive disorders.
  • History of drug abuse and chronic analgesic use.

Outcomes

Primary Outcomes

Pain assessment

Time Frame: 24 hours postoperatively.

The Numeric Pain Rating Scale is a valid and simple approach to pain assessment (0= no pain and 10= worst possible pain). Postoperative pain will be assessed at emergence and 2nd, 4th, 8th, 12th, 18th and 24th hour postoperatively.

Secondary Outcomes

  • The time of first analgesic request(24 hours postoperatively)
  • The total amount of morphine(24 hours postoperatively)

Study Sites (1)

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