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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06402006
Other study ID # FAMSU R79/2024
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date November 2024

Study information

Verified date May 2024
Source Ain Shams University
Contact Riham Fa Galal, MD
Phone 01022739211
Email rihamfathygalal@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The patients will be randomized into 2 equal groups by a computer-generated random numbers table, named group A, B. Group A: patients will receive Pericapsular nerve group block and lateral femoral cutaneous nerve blocks. Group B: Patients will receive Erector spinae plane block block. After IV access insertion and oxygen nasal cannula application, monitoring will be applied for all patients, sedation in the form of midazolam 0.02mg/kg with or without fentanyl 0.5-1 mcg/kg will be administered to any of the patients who felt discomfort or could not tolerate the procedure. For (Group B) PENG block will be done before spinal anesthesia. LFCN block will be performed. For (Group A), ESP block will be done before spinal anesthesia. Spinal anesthesia will be chosen as the main anesthetic technique. In postoperative period all patients will receive the same adjuvant multimodal analgesia which will be 1000 mg of paracetamol with or without 30 mg ketorolac depending on comorbidities and depending on the patients" needs.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Patients American Society of anesthesiologists' physical status (ASA) I to II. 2. Aged 18 to 65 years. 3. Both sexes. 4. Patients scheduled for total hip arthroplasty. Exclusion Criteria: 1. Patient refusal 2. ASA physical status III or more. 3. Patients with known allergy to any of the study drugs. 4. Infection at the site of injection. 5. Patients with history of cardiovascular disease. 6. Patients with renal disease. 7. Patients with hepatic disease. 8. Patients with neuromuscular disease. 9. Presence of any coagulopathy. 10. Chronic opioid, gabapentin or pregabalin use. 11. Patients with history of any psychiatric disorder. 12. BMI more than 35 kg/m2.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
PENG block
pericapsular nerve group block
LFCN block
Lateral femoral cutaneous nerve block
ESP block
Erector spinae plane block

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Outcome

Type Measure Description Time frame Safety issue
Primary individual visual analog pain scores at 0, 6, 12, 24 and 48 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable). The primary outcomes include : individual visual analog pain scores at 0, 6, 12, 24 and 48 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable). 48 hours
Primary presence of moderate-to-severe pain, defined as pain score 4 or greater during the first 48 h postoperative. presence of moderate-to-severe pain, defined as pain score 4 or greater during the first 48 h postoperative. 48 hours
Primary analgesic consumption in post-anesthesia care unit, and during the first 48 h post-surgery (converted to IV pethidine equivalents). analgesic consumption in post-anesthesia care unit, and during the first 48 h post-surgery (converted to IV pethidine equivalents). 48 hours
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