Clinical trial NCT06003738: Comparing Postoperative Pain After Pericapsular Nerve Block and Fascia Iliaca Block in Total Hip Arthroplasty
Official title: A Comparative Study Between the Postoperative Analgesic Effect of Pericapsular Nerve Group Block (PENG) and Fascia Iliaca Compartment Block (FICB) in Total Hip Arthroplasty: a Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the efficiency of post-operative analgesia by fascia iliaca compartment block versus pericapsular nerve group block block in reducing narcotic consumption during the first 24 hour post-operatively by using the Visual Analogue Scale.

Detailed description: Total hip arthroplasty is a widely used surgical treatment intervention for treating hip conditions such as femur neck fractures and advanced hip osteoarthritis.

Hip fractures are quite common, regardless of the age of the population (young or old), and they are extremely painful. A hip fracture is a serious injury with potentially life-threatening complications, and it is a common orthopedic emergency in elderly individuals. Early surgery within 48 hours of a fracture has been found to lower mortality and complication rates.

The pericapsular nerve group block is a novel regional analgesia technique to decrease pain after THA while preserving the motor function. The local anaesthetic is deposited using this method in the fascial plane between the psoas muscle and the superior pubic ramus, which aims sensory branches of the obturator, accessory obturator, and femoral nerves in the anterior capsule of the hip.

Fascia iliaca compartment block, for procedures on the femur and hip joint, is still a well-liked regional anaesthetic technique. Studies have found that FICB prevents complications by anaesthetizing the femoral nerve far from critical neurovascular structures while still giving enough analgesia.

Both blocks could be used to effectively reduce pain intensity up to 24 hours, total opioid consumption, and length of hospital stay in THA patients.

Eligibility criteria: Inclusion Criteria:

1. Age 18-80 years.
2. Sex: Both sexes.
3. American Society of Anaesthesiologists (ASA) Physical Status Class I, II, and III.
4. Scheduled for Total hip arthroplasty (THA) under spinal anesthesia.

Exclusion Criteria:

1. Declining to give a written informed consent.
2. History of allergy to the medications used in the study.
3. Contraindications to regional anesthesia (including patient refusal, coagulopathy, and local infection).
4. Psychiatric disorders.
5. Significant cognitive dysfunction.
6. American Society of Anesthesiologists (ASA) Physical Status Class IV.
7. Liver failure, renal insufficiency (estimated glomerular filtration rate \< 15 mL/min/1.73 m2).
8. Patients who had failed spinal anaesthesia were excluded from the study.
9. Pregnancy.

Primary outcomes:
measure: The effect of the studied blocks on the Visual Analogue Scale for pain
timeFrame: Immediately postoperatively (zero time)
measure: Change in the Visual Analogue Scale for pain
timeFrame: Every 2 hours during the first 6 hours
measure: Change in the Visual Analogue Scale for pain
timeFrame: every 6 hours in the first 24 hours postoperatively
Secondary outcomes:
measure: The total dose of nalbuphine in mg was used postoperatively per patient
timeFrame: 24 hours postoperatively
measure: Mean arterial blood pressure change
timeFrame: 24 hours postoperatively
measure: Heart rate change
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university hospitals
Study officials:
affiliation: Faculty of Medicine, Ain Shams University
name: Diaaeldin DA Aboelnile, MD, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: