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

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

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.

Study Overview

• Status: Recruiting
• Conditions: General Anesthesia; Geriatrics; Total Hip Arthroplasty; Pericapsular Nerve; Lumbar Erector Spinae Plane Blocks
• Intervention / Treatment: Drug: General anesthesia; Drug: Bupivacaine 0.5%; Drug: Bupivacaine 0.5%

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mai El Hamada, MSc; Phone Number: 00201285851295; Email: drmai7amada93@gmail.com

Study Locations

• Egypt
  • Tanta, Egypt, 31527
    • Recruiting
    • Faculty of medicine
    • Sub-Investigator: Ayman A Youssef, MD
    • Contact: Mai El Hamada, MSc; Phone Number: 00201285851295; Email: drmai7amada93@gmail.com
    • Sub-Investigator: Lobna M Elnasr, MD
    • Sub-Investigator: Motaz M Abosabaa, MD
    • Sub-Investigator: Mostafa I Sharaf, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: General anesthesia group; Patients will receive general anesthesia.	Drug: General anesthesia; Patients will receive general anesthesia.
Experimental: Erector spinae plane block group; Patients will receive general anesthesia and erector spinae plane block.	Drug: Bupivacaine 0.5%; Patients will receive general anesthesia and erector spinae plane block.; Other Names: Erector spinae plane block; Drug: Bupivacaine 0.5%; Patients will receive general anesthesia and erector spinae plane block with pericapsular nerve block.; Other Names: Pericapsular nerve block
Experimental: Pericapsular nerve block group; Patients will receive general anesthesia and erector spinae plane block with pericapsular nerve block.	Drug: Bupivacaine 0.5%; Patients will receive general anesthesia and erector spinae plane block.; Other Names: Erector spinae plane block; Drug: Bupivacaine 0.5%; Patients will receive general anesthesia and erector spinae plane block with pericapsular nerve block.; Other Names: Pericapsular nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean sevoflurane MAC to achieve bispectral index (BIS) values (45-55)	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	Intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain degree	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.	24 hours postoperatively
Fentanyl consumption.	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).	Intraoperatively
Arterial blood pressure	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.	Till the end of surgery (up to 2 hours)
Heart rate	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.	Till the end of surgery (up to 2 hours)
Total postoperative morphine consumption.	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.	First 24 hours after surgery
Patient satisfaction	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.	24 hours after surgery
Complications	Complications such as bradycardia, hypotension, nausea, vomiting, pruritis, respiratory depression will be recorded.	24 hours Postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 22, 2025
• First Submitted That Met QC Criteria: March 29, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 29, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: 36265MD311/11/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one yea
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No