Pericapsular Nerve Group (PENG) Block Versus Lumbar Erector Spinae Plane Block

NCT04899388 | Completed Phase 2

• 1 other identifier: 6818
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

assess and compare the efficacy of pericapsular nerve group block wersus lumber erector spinae plane block in reducing postoperative pain within the first 24 hours after hip surgeries.

Conditions

Pericapsular Nerve Group Block (PENG Block); Lumbar Erector Spinae Plane Block

Keywords

Lumbar Erector Spinae Plane Block, Pericapsular Nerve Group Block (PENG Block)

Outcome Measures

Primary Outcomes (1)

• the time to first postoperative rescue analgesia

  the time to ask for the first postoperative analgesia (morphine) when the patient is reporting NRS ≥ 3

  24 hours postoperative

Secondary Outcomes (6)

• Block performance time (min)

  immediately before surgery

• onset of sensory block

  after the block

• pain intensity

  30 minutes after the end of surgery ,3,6,12 hours postoperative.

• The total dose of rescue analgesia

  24 hours postoperative

• adverse effects

  24 hours postoperative

Study Arms (3)

PENG

ACTIVE COMPARATOR

the patients lied in the supine position. The probe was originally placed in a transverse plane above the anterior superior iliac spine in the ipsilateral surgical site and then counterclockwise rotated about 45 degrees to line up with the pubic ramus. The iliopubic eminence, iliopsoas muscle and tendon, femoral artery, and pectineus muscle were all visible in this view. By an in-plane technique, from lateral to medial, a 22-gauge, 80-mm needle was placed in the musculofascial plane between both the psoas tendon anteriorly and the pubic ramus posteriorly .The local anesthetic medication was delivered after negative aspiration while looking out for proper fluid distribution for a total volume of 20 mL of Bupivacaine 0.25%

Procedure: Pericapsular Nerve Block

ESPB

ACTIVE COMPARATOR

TThe patient was positioned at the lateral decubitus posture in the ipsilateral surgical site. The convex USG transducer was moved from the midline to the side of the operation and positioned 4-6 cm lateral to the L3 spinous process in a longitudinal parasagittal plane. The needle was advanced using the in-plane superior-to-inferior approach. The needle was advanced with the tip introduced up to the plane anterior to the "erector spinae muscle" and the posterior surface of the L3 transverse process. 0.5-1 ml of normal saline was administered for hydrodissection and to ensure proper placement .If there was any resistance during administering local anesthesia, the needle was modified by drawing it back a few millimeters. the prepared local anesthetic solution 20 ml bupivacaine 0.25 % was delivered through the point between both the transverse process and the erector spinae muscle

Procedure: Lumbar Erector Spinae Plane Block

control

PLACEBO COMPARATOR

patients received spinal anesthesia without any block

Drug: Fentanyl

Interventions

Pericapsular Nerve Block PROCEDURE

regional anaesthia

Also known as: PENG

PENG

Lumbar Erector Spinae Plane Block PROCEDURE

regional anaesthia

Also known as: LESB

ESPB

Fentanyl DRUG

intavenous

control

Eligibility Criteria

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

You may qualify if:

• Aged 65 to 75 years old. American Society of anesthesiologists physical status II and III. Body mass index of 25 to 30 kg/m2.

You may not qualify if:

• Altered mental status. History of trauma or multiple fractures Uncontrolled hypertension and or diabetes. Coagulopathy. Preexisting advanced kidney, liver, or heart disease. Allergies or contraindications to the study drugs. Chronic use of opioids or corticosteroids.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Aculty of Medicine,Zagazig University

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Howida A kamal, M.D

  zagazig U

  STUDY DIRECTOR

• Marwa m Medhat, M.D

  zagazig U

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: douple
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecture of anesthesia and surgical intensive care (Principal Investigator)

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: May 24, 2021
• Study Start: June 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: February 20, 2022
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)