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

Not Applicable

Completed

• Conditions: Retrolaminar Block; Ultrasound-guided Erector Spinae Plane Block; Thoracotomy; Postoperative Analgesia
• Interventions: Procedure: Control; Procedure: Ultrasound-guided Erector Spinae Plane Block; Procedure: Retrolaminar Block

• Registration Number: NCT05507281
• Lead Sponsor: Tanta University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-08-01
• Status Verified: 2022-08
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Study First Submitted: 2022-08-17
• Study First Submitted QC: 2022-08-17
• Study First Posted: 2022-08-18
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control	Patients received general anesthesia alone.
Ultrasound-guided Erector Spinae Plane Block	Ultrasound-guided Erector Spinae Plane Block	A 22-gauge needle is inserted at a puncture site lateral to the target spinous process using ultrasound imaging and advanced until contact is made with the transverse process. The local anesthetic agent will be injected between the transverse process and the erector spinae muscle using 20 ml (19ml bupivacaine 0.25% plus 1ml dexamethasone 4mg).
Retrolaminar Block	Retrolaminar Block	A 22-gauge needle is inserted at a puncture site lateral to the target spinous process using ultrasound imaging and advanced caudally or cranially until it contacts the lamina. The local anesthetic agent will be injected on the lamina using 20 ml (19ml bupivacaine 0.25% plus 1ml dexamethasone 4mg).

Primary Outcome Measures

Name	Time	Method
Pain assessment	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 Outcome Measures

Name	Time	Method
The time of first analgesic request	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.
The total amount of morphine	24 hours postoperatively	The total amount of morphine consumption in the first 24 hours postoperatively.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, Gharbia, Egypt