A Comparative Study Between Ultrasound Guided Erector Spinae Plane Block and Combined Ultrasound Guided Pericapsular Nerve Group and Lateral Femoral Nerve Block Following Total Hip Arthroplasty
1 other identifier
interventional
50
1 country
1
Brief 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. 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 A) PENG block will be done before spinal anesthesia. LFCN block will be performed. For (Group B), 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2024
CompletedFirst Posted
Study publicly available on registry
May 7, 2024
CompletedStudy Start
First participant enrolled
May 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedMay 4, 2025
May 1, 2025
7 months
April 28, 2024
May 2, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (2)
Combined hip joint PENG block and LFCN block
EXPERIMENTALCombined hip joint pericapsular nerve group block(PENG) and lateral femoral cutaneous nerve block
ESP block
EXPERIMENTALErector spinae plane block(ESP)
Interventions
Lateral femoral cutaneous nerve block
Eligibility Criteria
You may qualify if:
- Patients American Society of anesthesiologists' physical status (ASA) I to III.
- Aged 18 to 65 years.
- Both sexes.
- Patients scheduled for total hip arthroplasty.
You may not qualify if:
- Patient refusal
- ASA physical status III or more.
- Patients with known allergy to any of the study drugs.
- Infection at the site of injection.
- Patients with history of cardiovascular disease.
- Patients with renal disease.
- Patients with hepatic disease.
- Patients with neuromuscular disease.
- Presence of any coagulopathy.
- Chronic opioid, gabapentin or pregabalin use.
- Patients with history of any psychiatric disorder.
- BMI more than 35 kg/m2.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain shams university hospitals
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
April 28, 2024
First Posted
May 7, 2024
Study Start
May 15, 2024
Primary Completion
November 30, 2024
Study Completion
November 30, 2024
Last Updated
May 4, 2025
Record last verified: 2025-05