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

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

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

Study Overview

• Status: Completed
• Conditions: Thoracotomy; Postoperative Analgesia; Retrolaminar Block; Ultrasound-guided Erector Spinae Plane Block
• Intervention / Treatment: Procedure: Control; Procedure: Ultrasound-guided Erector Spinae Plane Block; Procedure: Retrolaminar Block

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Gharbia
    • Tanta, Gharbia, Egypt, 31527
      • Tanta university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control group; Patients received general anesthesia alone.	Procedure: Control; General anesthesia
Experimental: 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).	Procedure: Ultrasound-guided Erector Spinae Plane Block; ultrasound-guided ipsilateral Erector Spinae Plane Block (20 ml (19ml bupivacaine 0.25% plus 1ml dexamethasone 4mg)).
Experimental: 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).	Procedure: Retrolaminar Block; ultrasound-guided ipsilateral Retrolaminar Block (20 ml (19ml bupivacaine 0.25% plus 1ml dexamethasone 4mg)).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The total amount of morphine	The total amount of morphine consumption in the first 24 hours postoperatively.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: 34580/3/21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No