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

Postoperative Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05507281
• Other study ID #: 34580/3/21
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: August 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Analgesia
• Retrolaminar Block
• Thoracotomy

Intervention

Procedure:
• Ultrasound-guided Erector Spinae Plane Block
ultrasound-guided ipsilateral Erector Spinae Plane Block (20 ml (19ml bupivacaine 0.25% plus 1ml dexamethasone 4mg)).
• Retrolaminar Block
ultrasound-guided ipsilateral Retrolaminar Block (20 ml (19ml bupivacaine 0.25% plus 1ml dexamethasone 4mg)).
• Control
General anesthesia

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment	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.	24 hours postoperatively.
Secondary	The time of first analgesic request	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.	24 hours postoperatively
Secondary	The total amount of morphine	The total amount of morphine consumption in the first 24 hours postoperatively.	24 hours postoperatively