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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound-guided Erector Spinae Plane Block
Retrolaminar Block
Control
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Analgesia

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Tanta University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Control group

Ultrasound-guided Erector Spinae Plane Block

Retrolaminar Block

Arm Description

Patients received general anesthesia alone.

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 17, 2022
Last Updated
August 24, 2022
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05507281
Brief Title
Ultrasound-guided Erector Spinae Plane Block Versus Retrolaminar Block for Postoperative Analgesia in Thoracotomy
Official Title
Efficacy of Ultrasound-guided Erector Spinae Plane Block Versus Retrolaminar Block for Postoperative Analgesia in Patients Undergoing Thoracotomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Analgesia, Retrolaminar Block, Ultrasound-guided Erector Spinae Plane Block, Thoracotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Patients received general anesthesia alone.
Arm Title
Ultrasound-guided Erector Spinae Plane Block
Arm Type
Experimental
Arm Description
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).
Arm Title
Retrolaminar Block
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided Erector Spinae Plane Block
Intervention Description
ultrasound-guided ipsilateral Erector Spinae Plane Block (20 ml (19ml bupivacaine 0.25% plus 1ml dexamethasone 4mg)).
Intervention Type
Procedure
Intervention Name(s)
Retrolaminar Block
Intervention Description
ultrasound-guided ipsilateral Retrolaminar Block (20 ml (19ml bupivacaine 0.25% plus 1ml dexamethasone 4mg)).
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
General anesthesia
Primary Outcome Measure Information:
Title
Pain assessment
Description
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.
Time Frame
24 hours postoperatively.
Secondary Outcome Measure Information:
Title
The time of first analgesic request
Description
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.
Time Frame
24 hours postoperatively
Title
The total amount of morphine
Description
The total amount of morphine consumption in the first 24 hours postoperatively.
Time Frame
24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
31527
Country
Egypt

12. IPD Sharing Statement

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

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