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

NCT05507281 | Completed

• 1 other identifier: 34580/3/21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The time of first analgesic request

  24 hours postoperatively

• The total amount of morphine

  24 hours postoperatively

Study Arms (3)

Control group

SHAM COMPARATOR

Patients received general anesthesia alone.

Procedure: Control

Ultrasound-guided Erector Spinae Plane Block

EXPERIMENTAL

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).

Procedure: Ultrasound-guided Erector Spinae Plane Block

Retrolaminar Block

EXPERIMENTAL

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).

Procedure: Retrolaminar Block

Interventions

Ultrasound-guided Erector Spinae Plane Block PROCEDURE

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

Ultrasound-guided Erector Spinae Plane Block

Retrolaminar Block PROCEDURE

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

Retrolaminar Block

Control PROCEDURE

General anesthesia

Control group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 18, 2022
• Study Start: August 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 29, 2022

Record last verified: 2022-08

Locations

EG (1)