Ultrasound Guided Erector Spinae Block for Postoperative Analgesia in Thoracotomy Patients

NCT03749395 | Completed

• 1 other identifier: Erector spinae block
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

aim of this study is to assess and compare between the efficacy of the new U/S guided erector spinae plane block (ESP) and the conventional methods of systemic analgesics in adult patients scheduled for elective thoracotomy surgery.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 24 hours morphine consumption

  total morphine consumption in both groups will be assessed in the postoperative period

  24 hours postoperative

Secondary Outcomes (3)

• The quality of analgesia based on visual analogue scale (VAS) pain scores.

  every 6 hours for 24 hours

• Side effects of opioid usage

  2, 6, 12, 24 hours postoperative

• Procedural morbidity

  2, 6, 12, 24 hours postoperative

Study Arms (2)

Erector Spinae Plane Block group

ACTIVE COMPARATOR

* The Erector Spinae Plane block will be done as follow,the patient will be placed in a sitting position and the ultrasound probe will be placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae . the needle will be inserted in a cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced by visible linear spread of fluid beneath muscle upon injection . A total of 20 mL of 0.25% bupivacaine will be injected here. * All patients will receive general anesthesia as described in conventional group

Procedure: Erector Spinae Plane Block

Conventional group

NO INTERVENTION

* Nothing will be injected * All patients will receive pre-oxygenation with O2 100% for 3 min. Anesthesia will be induced by using fentanyl 1μg/kg, propofol 1.5-2 mg/kg and atracurium 0.5 mg/kg will be used for muscle relaxation. Anesthesia will be maintained by controlled ventilation with oxygen and air (50:50) with target of EtCo2≈ 35-40 mmHg, isoflurane 1:1.5 minimum alveolar concentration (MAC), 0.5μg/kg fentanyl will be given intraoperative when either heart rate or Non Invasive Blood Pressure report an increase by more than 20% of the basal records. Anesthesia will be discontinued and tracheal extubation will be done once patient fulfilled the extubation criteria.

Interventions

Erector Spinae Plane Block PROCEDURE

The patient will be placed in a sitting position and the ultrasound probe will be placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae . the needle will be inserted in a cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced by visible linear spread of fluid beneath muscle upon injection . A total of 20 mL of 0.25% bupivacaine will be injected here.

Erector Spinae Plane Block group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged \>18 years
• American Society of Anesthesiologists Physical Status I or IV scheduled for elective thoracotomy

You may not qualify if:

• Refusal of the patient to provide written consent
• history of relevant drug allergy
• age less than 18
• obesity BMI \> 40 kg/m2
• infection of the skin at the site of needle puncture area
• coagulopathy
• Pregnant females

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Banha University Hospital

Banhā, 13518, Egypt

Location

Related Publications (1)

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• faculty of medicine

  faculty of medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The practitioner and the patient are not blinded.The outcomes assessor will not know which group each patient is in.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ultrasound Guided Erector Spinae Block for Postoperative Analgesia in Thoracotomy patients : A Prospective, Randomized, Observer-Blind,Controlled Clinical Trial

Model Details: Two parallel arms. One group will receive erector spinae plane block, and the other will receive nothing.

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 21, 2018
• Study Start: December 5, 2018
• Primary Completion: November 5, 2019
• Study Completion: November 5, 2019
• Last Updated: August 18, 2020

Record last verified: 2020-08

Locations

EG (1)