Evaluation of the Effectiviness of Two Different Bupivacaine Concentrations of the Pericapsular Nerve Group (PENG) Block

NCT05921110 | Unknown

• 1 other identifier: AIBU-TF-AR-II-004
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

The use of regional anaesthesia techniques as part of multimodal analgesia in hip surgeries improves postoperative analgesia. PENG (Pericapsular nerve group) block is an effective motor sparing analgesia technique used in hip surgeries. The purpose of this study was to assess the efficacy of PENG block in terms of analgesic requirements and pain density in patients undergoing hip surgery, using two different concentrations of local anaesthetic.

Conditions

Hip Fractures; Postoperative Pain

Keywords

PENG Block; Hip Surgery; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Analgesic requirement

  The amount of analgesic required in the first postoperative 24 hours is the primary outcome of this study.

  First 24 Hour

Secondary Outcomes (1)

• VAS ( Visual Analogue Scale) scores

  1th, 2nd, 4th, 8th,12th,18th and 24th hours

Study Arms (3)

PENG Block %0,25

ACTIVE COMPARATOR

PENG Block will be applied with 0.25% bupivacaine in 20 ml volume under ultrasound guidance.

Procedure: Pericapsular nerve group block 0,25%

PENG Block %0,16

ACTIVE COMPARATOR

PENG Block will be applied with 0.16% bupivacaine in 20 ml volume under ultrasound guidance.

Procedure: Pericapsular nerve group block 0,16%

Control Group

NO INTERVENTION

Control

Interventions

Pericapsular nerve group block 0,25% PROCEDURE

Used for postoperative anagesia after hip operations under spinal anaesthesia. Drug: Bupivacaine (Block Drug) For block performances, 0,25% Bupivacaine will be used at 20 ml volume.

Also known as: PENG Block

PENG Block %0,25

Pericapsular nerve group block 0,16% PROCEDURE

Used for postoperative anagesia after hip operations under spinal anaesthesia. Drug: Bupivacaine (Block Drug) For block performances, 0,16% Bupivacaine will be used at 20 ml volume

Also known as: PENG Block

PENG Block %0,16

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I- III risk undergoing hip surgery.

You may not qualify if:

• Contraindications for regional blocks (eg. patient refusal, coagulopathy, infection at the injection site), allergic reaction to local anesthetics and other analgesics.

Sponsors & Collaborators

• Ilker Ital: lead
• Abant Izzet Baysal University: collaborator

Study Sites (2)

Bolu Abant İzzet Baysal Medical School

Bolu, 14030, Turkey (Türkiye)

RECRUITING

Bolu Abant İzzet Baysal University Faculty of Medicine

Bolu, 14030, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Remily EA, Hochstein SR, Wilkie WA, Mohamed NS, Thompson JV, Kluk MW, Nace J, Delanois RE. The pericapsular nerve group block: a step towards outpatient total hip arthroplasty? Hip Int. 2022 May;32(3):318-325. doi: 10.1177/1120700020978211. Epub 2020 Dec 3.

  PMID: 33269617 BACKGROUND

• Guven Kose S, Kose HC, Arslan G, Eler Cevik B, Tulgar S. Evaluation of ultrasound-guided adductor canal block with two different concentration of bupivacaine in arthroscopic knee surgery: A feasibility study. Int J Clin Pract. 2021 Nov;75(11):e14747. doi: 10.1111/ijcp.14747. Epub 2021 Sep 3.

  PMID: 34428334 BACKGROUND

• Del Buono R, Padua E, Pascarella G, Costa F, Tognu A, Terranova G, Greco F, Fajardo Perez M, Barbara E. Pericapsular nerve group block: an overview. Minerva Anestesiol. 2021 Apr;87(4):458-466. doi: 10.23736/S0375-9393.20.14798-9. Epub 2021 Jan 12.

  PMID: 33432791 BACKGROUND

• Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.

  PMID: 30063657 BACKGROUND

MeSH Terms

Conditions

Hip Fractures; Pain, Postoperative

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Fatma Saridemir

  Bolu Abant İzzet Baysal Medical School

  PRINCIPAL INVESTIGATOR

• Hamit Yoldas

  Bolu Abant İzzet Baysal Medical School

  STUDY DIRECTOR

• Ilker Ital

  Bolu Abant İzzet Baysal Medical School

  STUDY CHAIR

• Cengiz Isık

  Bolu Abant İzzet Baysal Medical School

  STUDY CHAIR

Central Study Contacts

Ilker Ital

CONTACT

+905337723300; ilkerital@gmail.com

Fatma Saridemir

CONTACT

+905067179398; fatos_dtz2@hotmail.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: SPONSOR INVESTIGATOR
• PI Title: Assistan Professor Doctor

Study Record Dates

• First Submitted: April 30, 2023
• First Posted: June 27, 2023
• Study Start: May 15, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

TU (2)