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

NCT ID: NCT05507281

Last Updated: 2022-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-08-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Postoperative Analgesia Retrolaminar Block Ultrasound-guided Erector Spinae Plane Block Thoracotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were randomly allocated into 3 equal groups (Control group, Ultrasound-guided Erector Spinae Plane Block group, Retrolaminar Block, 20 patients each) through sealed envelopes.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
An anesthesiologist gave the block and outcomes were obtained by another one blinded to the study group. PHILIPS ultrasound machine and high frequency linear array probe with a frequency of 5-13 MHZ will be used.

Study Groups

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Control group

Patients received general anesthesia alone.

Group Type SHAM_COMPARATOR

Control

Intervention Type PROCEDURE

General anesthesia

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).

Group Type EXPERIMENTAL

Ultrasound-guided Erector Spinae Plane Block

Intervention Type PROCEDURE

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

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).

Group Type EXPERIMENTAL

Retrolaminar Block

Intervention Type PROCEDURE

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

Interventions

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Ultrasound-guided Erector Spinae Plane Block

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

Intervention Type PROCEDURE

Retrolaminar Block

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

Intervention Type PROCEDURE

Control

General anesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Adel Momen Elshazly

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, Gharbia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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34580/3/21

Identifier Type: -

Identifier Source: org_study_id

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