Ultrasound Guided Erector Spinae Block for Postoperative Analgesia in Thoracotomy Patients

Postoperative Pain Clinical Trial

Official title:

Ultrasound Guided Erector Spinae Block for Postoperative Analgesia in Thoracotomy Patients : A Prospective, Randomized, Observer-Blind,Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03749395
• Other study ID #: Erector spinae block
• Status: Completed
• Phase: N/A
• Start date: December 5, 2018
• Est. completion date: November 5, 2019

Study information

• Verified date: August 2020
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Thoracotomy is considered the most painful of surgical procedures and providing effective analgesia is the onus for all anesthetists. Ineffective pain relief impedes deep breathing, coughing, and remobilization culminating in atelectasis and pneumonia.The erector spinae plane (ESP) block is a newly-described technique for treating thoracic pain, and has several advantages that make it an attractive alternative to these more invasive procedures.Ultrasound guided erector spinae (ESP) block is a regional anesthesia technique, recently described by (Forero; et al.) for use in thoracic neuropathic pain. ESP block is reported to lead to analgesic effect on somatic and visceral pain by effecting the ventral rami and rami communicantes that include sympathetic nerve fibers, as LA spreads through the paravertebral space . When performed bilaterally it has been reported to be as effective as thoracic epidural analgesia.ESP block leads to effective postoperative analgesia when performed at T 4-5 level for breast and thoracic surgery. The ESP block , will be performed 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 5, 2019
• Est. primary completion date: November 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients aged >18 years

• American Society of Anesthesiologists Physical Status I or IV scheduled for elective thoracotomy

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Erector Spinae Plane Block
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.

Locations

Country	Name	City	State
Egypt	Banha University Hospital	Banha

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hours morphine consumption	total morphine consumption in both groups will be assessed in the postoperative period	24 hours postoperative
Secondary	The quality of analgesia based on visual analogue scale (VAS) pain scores.	VAS score will be obtained in the postoperative period at preset time intervals.Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.No pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).	every 6 hours for 24 hours
Secondary	Side effects of opioid usage	Any evidence of opioid-related morbidity or adverse effects eg. nausea,vomiting,pruritus.These effects will be assessed by questionnaire.	2, 6, 12, 24 hours postoperative
Secondary	Procedural morbidity	Any evidence of procedure-related morbidity	2, 6, 12, 24 hours postoperative