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

NCT06904703 | Recruiting

• 1 other identifier: 36265MD311/11/24
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pericapsular Nerve; Lumbar Erector Spinae Plane Blocks; Geriatrics; Total Hip Arthroplasty; General Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Pain degree

  24 hours postoperatively

• Fentanyl consumption.

  Intraoperatively

• Arterial blood pressure

  Till the end of surgery (up to 2 hours)

• Heart rate

  Till the end of surgery (up to 2 hours)

• Total postoperative morphine consumption.

  First 24 hours after surgery

Study Arms (3)

General anesthesia group

EXPERIMENTAL

Patients will receive general anesthesia.

Drug: General anesthesia

Erector spinae plane block group

EXPERIMENTAL

Patients will receive general anesthesia and erector spinae plane block.

Drug: Bupivacaine 0.5%

Pericapsular nerve block group

EXPERIMENTAL

Patients will receive general anesthesia and erector spinae plane block with pericapsular nerve block.

Drug: Bupivacaine 0.5%

Interventions

General anesthesia DRUG

Patients will receive general anesthesia.

General anesthesia group

Bupivacaine 0.5% DRUG

Patients will receive general anesthesia and erector spinae plane block.

Also known as: Erector spinae plane block

Erector spinae plane block group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine

Tanta, 31527, Egypt

RECRUITING

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Mai El Hamada, MSc

CONTACT

00201285851295; drmai7amada93@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management Department, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: April 1, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one yea
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)