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

Pericapsular Nerve Group (PENG) Block Versus Lumbar Erector Spinae Plane Block as Postoperative Analgesia in Hip Surgeries: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pericapsular Nerve Group Block (PENG Block); Lumbar Erector Spinae Plane Block
• Intervention / Treatment: Procedure: Pericapsular Nerve Block; Procedure: Lumbar Erector Spinae Plane Block; Drug: Fentanyl

Detailed Description

after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 3groups each one containing 23 patients ,PENG group (n =23 ): The patients will receive Pericapsular Nerve Group Block (PENG Block) before positioning for spinal anesthesia.

ESPS group E (n =23 ): The patients will receive Lumbar Erector Spinae Plane Block before positioning for spinal anesthesia.

Control group C(n =23 ): patients received spinal anesthesia without any block.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • El Sharkia
    • Zagazig, El Sharkia, Egypt, 44519
      • Aculty of Medicine,Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 75 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

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
Active Comparator: PENG; 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; regional anaesthia; Other Names: PENG
Placebo Comparator: control; patients received spinal anesthesia without any block	Drug: Fentanyl; intavenous
Active Comparator: ESPB; 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; regional anaesthia; Other Names: LESB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Block performance time (min)	time from placement of ultrasound probe on the patient's skin to the end of local anesthetic injection	immediately before surgery
Patient satisfaction	related to block performance, post-operative pain relief was evaluated by an 11- point satisfaction score (0=unsatisfied and 10 = most satisfied), and the score was divided as follows 0-3 (not satisfied), 4-6 (partly satisfied), and 7-10 (highly satisfied).	24 hours postoperative
onset of sensory block	the time between the end of the injection of local anesthetic (bupivacaine) and the loss of pin prick sensation using a sterile 25G needle in the operating field.	after the block
pain intensity	using an 11point numeric rating scale (NRS)(11) : 0: no pain,10=worst imaginable pain) 1-3Mild Pain (nagging, annoying, interfering little with activities of daily living (ADLs). 4-6Moderate Pain (interferes significantly with activities of daily living(ADLs) 7-10Severe Pain (disabling; unable to perform ADLs) at rest and during movement (during45-degree passive flexion of the hip with the ipsilateral knee flexed)	30 minutes after the end of surgery ,3,6,12 hours postoperative.
The total dose of rescue analgesia	The total dose of rescue analgesia	24 hours postoperative
adverse effects	nausea, vomiting ,hypotension ,bradycardia and hematoma	24 hours postoperative

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Study Director: Howida A kamal, M.D, zagazig U; Principal Investigator: Marwa m Medhat, M.D, zagazig U

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): February 20, 2022

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Lumbar Erector Spinae Plane Block, Pericapsular Nerve Group Block (PENG Block)
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: 6818 (CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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