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NCT Number: NCT06904703

Pericapsular Nerve Group and Lumbar Erector Spinae Plane Blocks for Geriatrics Undergoing Total Hip Arthroplasty

This study will be conducted to evaluate the effect of pericapsular nerve group and erector spinae plane block as adjuvants to general anesthesia in geriatrics undergoing total hip arthroplasty.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Tanta, 31527, Egypt

Location status: Recruiting

Location contact

Ayman A Youssef, MD

SUB_INVESTIGATOR

Lobna M Elnasr, MD

SUB_INVESTIGATOR

Mai El Hamada, MSc

CONTACT

[email protected]

00201285851295

Mostafa I Sharaf, MD

SUB_INVESTIGATOR

Motaz M Abosabaa, MD

SUB_INVESTIGATOR

About this study

Total hip arthroplasty is one of the most common major orthopedic procedures to improve a patient's functional status and quality of life. Total hip arthroplasty is one of the most cost-effective and consistently successful surgeries performed in orthopedics and can be associated with significant postoperative pain.

General anesthesia may be considered more versatile and suitable for patients with complex medical histories or those who cannot tolerate spinal anesthesia. However, older patients undergoing hip fracture surgery under general anesthesia may experience a higher risk of postoperative delirium, prolonged sedation, and respiratory complications. Moreover, delayed mobilization is possible, leading to a higher incidence of complications such as deep vein thrombosis and pressure sores.

The target nerves of the hip joint arise from the lumbar plexus (L1-L4), the lumbosacral trunk of the sacral plexus (L4-L5), and the sacral spinal nerves (S1-S4) (7). The femoral nerve, obturator nerve, and the accessory obturator nerve supply the anterior capsule of the hip; the sciatic nerve and the nerve to the quadratus femoris mostly supply the articular branches to the posterior capsule of the hip joint The erector spinae plane block is a novel inter-fascial plane block targets the dorsal and ventral rami of the spinal nerves, is a newer regional anesthetic technique that can be used to provide analgesia for a variety of surgical procedures or to manage acute or chronic pain. This block can potentially provide analgesia to the posterior pelvis potentially safer alternative to epidural or paravertebral techniques, areas often involved in hip fracture pain.

The pericapsular nerve group block targets the articular branches of the femoral and obturator nerves near the hip joint capsule. By blocking these nerves, the pericapsular nerve group block effectively provides analgesia to the hip joint, particular tissues, and proximal femur.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged >75 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) classification I-III.
  • Undergoing total hip arthroplasty under general anesthesia.

Exclusion criteria

  • Patient refusal.
  • Body mass index (BMI) > 30 kg/m2.
  • Allergy to local anesthesia drugs.
  • Infection at the site of intervention.
  • Coagulopathies.
  • Preexisting advanced diseases of the kidney or liver.

Treatment and study plan

General anesthesia

Drug

Patients will receive general anesthesia.

Bupivacaine 0.5%

Drug

Patients will receive general anesthesia and erector spinae plane block.

Other names: Erector spinae plane block

Primary outcomes

  1. Mean sevoflurane MAC to achieve bispectral index (BIS) values (45-55)

    Time frame: Intraoperatively

    Sevoflurane will be adjusted to maintain a steady state with a BIS value in the range of 45-55 and will be fixed through the study period

Secondary outcomes

  1. Pain degree

    Time frame: 24 hours postoperatively

    Each patient will be instructed about postoperative pain assessment with the Numerical Rating Scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").Pain intensity will be measured using a 10-point NRS at rest at 2, 4, 8, 12, 18, and 24 hours postoperatively.

  2. Fentanyl consumption.

    Time frame: Intraoperatively

    Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).

  3. Arterial blood pressure

    Time frame: Till the end of surgery (up to 2 hours)

    MAP will be recorded pre-induction of anesthesia, post-induction of anesthesia and before performing of block, and every 15 min till the end of surgery. Intraoperative arterial blood pressure will be assessed. Hypotension (decrease in basal mean arterial blood pressure by 20%) will be treated with IV fluid.

  4. Heart rate

    Time frame: Till the end of surgery (up to 2 hours)

    HR will be recorded pre-induction of anesthesia, post-induction of anesthesia and before performing of block, and every 15 min till the end of surgery.

  5. Total postoperative morphine consumption.

    Time frame: First 24 hours after surgery

    Total postoperative morphine consumption in the first 24h after surgery will be recorded. Rescue analgesia of morphine will be given as 0.05mg/kg bolus if the Numerical Rating Scale (NRS) > 3 to be repeated after 30 min if pain persists until the NRS < 4.

  6. Patient satisfaction

    Time frame: 24 hours after surgery

    Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied). It will be assessed 24 hours after surgery.

  7. Complications

    Time frame: 24 hours Postoperatively

    Complications such as bradycardia, hypotension, nausea, vomiting, pruritis, respiratory depression will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Mai El Hamada, MSc

CONTACT

[email protected]

00201285851295

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Combination of Pericapsular Nerve Group and Lumbar Erector Spinae Plane Blocks for Geriatrics Undergoing Total Hip Arthroplasty Under General Anesthesia: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2025
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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