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Completed

NCT Number: NCT05507281

Ultrasound-guided Erector Spinae Plane Block Versus Retrolaminar Block for Postoperative Analgesia in Thoracotomy

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

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound-Guided Erector Spinae Plane Block

Procedure

ultrasound-guided ipsilateral Erector Spinae Plane Block (20 ml (19ml bupivacaine 0.25% plus 1ml dexamethasone 4mg)).

retrolaminar block

Procedure

ultrasound-guided ipsilateral Retrolaminar Block (20 ml (19ml bupivacaine 0.25% plus 1ml dexamethasone 4mg)).

Control

Procedure

General anesthesia

Primary outcomes

  1. 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

  1. The time of first analgesic request

    Time frame: 24 hours postoperatively

    The time of first analgesic request. IV morphine sulphate 0.05 mg/kg will be administered as rescue analgesic if Numeric Pain Rating Scale is ≥ 4.

  2. The total amount of morphine

    Time frame: 24 hours postoperatively

    The total amount of morphine consumption in the first 24 hours postoperatively.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 18, 2022
Registry last updated
Aug 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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