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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05247021
Other study ID # ainshmas university
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 22, 2021
Est. completion date June 2022

Study information

Verified date December 2021
Source Ain Shams University
Contact amgad A hamdi, MSc
Phone 01002400389
Email amgadhamdi@med.asu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aim of this study was to assess the efficacy of erector spinae plane block (ESB) for postoperative pain management in lumbar spine surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 44
Est. completion date June 2022
Est. primary completion date April 22, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: - Patients American Society of Anesthesiologists physical status (ASA) I and II. - Both sexes. - Age between 20 to 60 years old. - Scheduled for lumbar spine surgeries. Exclusion Criteria: - Patients who received long acting opioids preoperatively. - Patients with bleeding disorders and coagulopathy. - Infection at the injection site. - Allergy to local anesthetics. - Patients with significant cognitive dysfunction. - Patients with diabetic neuropathy. - Patients with uncontrolled hypertension or diabetes. - Patients with advanced cardiac, respiratory, hepatic or renal disease. - Patients with viral hepatitis or HIV.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
erector spinae block for group E
. The patient will be placed in the prone position. A high-frequency linear probe or a curved array probe, depending on the BMI of the patient, will be placed in longitudinal alignment, 2-3cm lateral to the vertebral column. The transverse processes of the vertebrae at the level of surgery, the erector spinae muscle, and the psoas muscle will be identified. A 5- or 8-cm 22-G ultrasound needle will be inserted with an in-plane technique in a cephalad-to-caudal direction until bone contact with the top of the transverse process is reached. After slight retraction of the needle, 20ml of bupivacaine 0.25% will be injected behind the erector spinae muscle. The same procedure will be repeated on the contralateral side.

Locations

Country Name City State
Egypt Ain Shams University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Singh S, Choudhary NK, Lalin D, Verma VK. Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Oct;32(4):330-334. doi: 10.1097/ANA.0000000000000603. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary the postoperative 24 hours morphine consumption the analgesic effect of erector spine block will be assessed postoperative by numeric rating scale (NRS), if NRS is more than 3 the patient will receive a rescue dose of 5 milligrams of morphine 24 hours postoperative
Secondary Mean Blood pressure in mmHg Measure mean blood pressure of patients postoperative every 4 hours 24 hours postoperative
Secondary Heart rate Measure heart of the patients postoperative every 4 hours 24 hours postoperative
Secondary Patient satisfaction Measure patient satisfaction by asking the patient if he is satisfied or not " yes or no" 24 hours postoperative
Secondary First time of mobilization to a chair Measure the time to first mobilization to a chair in minutes 24 hours postoperative
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