Combined Lumbar Erector Spinae Plane Block and Pericapsular Nerve Group Block in Patients Undergoing Hip Surgeries

NCT05930171 | Completed Phase 4 DMC

• 1 other identifier: Lumbar ESPB and PENG block
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are going to evaluate the postoperative analgesic efficacy of combined LESPB and PENG block after hip surgeries.

Conditions

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

Keywords

Lumbar Erector Spinae Plane Block; Pericapsular Nerve Group Block; Hip Surgeries; L-ESPB; PENG block

Outcome Measures

Primary Outcomes (5)

• Postoperative pain intensity

  Postoperative pain intensity using Visual Analogue Scale (VAS) (which is over 10 centimeter scale) (where 0 indicates no pain at all , 10 indicates severe pain)

  at 1 hour after the block

• Postoperative pain intensity

  Postoperative pain intensity using Visual Analogue Scale (VAS) (which is over 10 centimeter scale) (where 0 indicates no pain at all , 10 indicates severe pain)

  at 3 hour after the block

• Postoperative pain intensity

  Postoperative pain intensity using Visual Analogue Scale (VAS) (which is over 10 centimeter scale) (where 0 indicates no pain at all , 10 indicates severe pain)

  at 6 hour after the block

• Postoperative pain intensity

  Postoperative pain intensity using Visual Analogue Scale (VAS) (which is over 10 centimeter scale) (where 0 indicates no pain at all , 10 indicates severe pain)

  at 12 hour after the block

• Postoperative pain intensity

  Postoperative pain intensity using Visual Analogue Scale (VAS) (which is over 10 centimeter scale) (where 0 indicates no pain at all , 10 indicates severe pain)

  at 24 hour after the block

Secondary Outcomes (8)

• Vital signs

  assessed at preoperative, postoperative (0,3,6,12,24 hours), Value is averaged of total measurements

• Vital signs

  assessed at preoperative, postoperative (0,3,6,12,24 hours), Value is averaged of total measurements

• Vital signs

  assessed at preoperative, postoperative (0,3,6,12,24 hours), Value is averaged of total measurements

• Time to first analgesic administration

  24 hours postoperative

• Total Analgesic Requirements

  24 hours postoperative

Study Arms (2)

Group A: L-ESPB and PENG

ACTIVE COMPARATOR

receiving after end of hip surgery (PENG) block first and (LESPB) at lumber 4 vertebrae level

Procedure: Ultrasound guided L-ESPB and PENG block using Bupivacaine

Group B: conventional analgesia

ACTIVE COMPARATOR

receiving postoperative conventional analgesia in form of acetaminophen 15 mg/kg/6hrs

Drug: Postoperative conventional analgesia in form of Acetaminophen

Interventions

Ultrasound guided L-ESPB and PENG block using Bupivacaine PROCEDURE

Combined Lumbar Erector Spinae Plane Block and Pericapsular Nerve Group Block in Patients Undergoing Hip Surgeries

Also known as: Lumbar Erector Spinae Plane Block and Pericapsular Nerve Group Block

Group A: L-ESPB and PENG

Postoperative conventional analgesia in form of Acetaminophen DRUG

Postoperative conventional analgesia in form of acetaminophen 15 mg/kg/6hrs

Also known as: Conventional analgesia

Group B: conventional analgesia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-70 years old
• American Society of Anesthesiologists (ASA) class I to III
• Both sex
• Scheduled for hip surgery.

You may not qualify if:

• Refusal to participate
• Allergy to any of the study drugs
• Bleeding disorder
• Localized infection
• Neurological disease
• Renal impairment
• Psychological disorders
• Opioid dependent
• Intellectual disability (patients unable to express pain with visual analogue)
• Morbid obesity.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia university

Menoufia, Menoufia, Egypt

Location

Related Publications (11)

• Ahiskalioglu A, Tulgar S, Celik M, Ozer Z, Alici HA, Aydin ME. Lumbar Erector Spinae Plane Block as a Main Anesthetic Method for Hip Surgery in High Risk Elderly Patients: Initial Experience with a Magnetic Resonance Imaging. Eurasian J Med. 2020 Feb;52(1):16-20. doi: 10.5152/eurasianjmed.2020.19224.

  PMID: 32158307 BACKGROUND

• Santonastaso DP, De Chiara A, Kraus E, Bagaphou TC, Tognu A, Agnoletti V. Ultrasound guided erector spinae plane block: an alternative technique for providing analgesia after total hip arthroplasty surgery? Minerva Anestesiol. 2019 Jul;85(7):801-802. doi: 10.23736/S0375-9393.19.13459-1. Epub 2019 Mar 12. No abstract available.

  PMID: 30871306 BACKGROUND

• Tulgar S, Kose HC, Selvi O, Senturk O, Thomas DT, Ermis MN, Ozer Z. Comparison of Ultrasound-Guided Lumbar Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block for Postoperative Analgesia in Hip and Proximal Femur Surgery: A Prospective Randomized Feasibility Study. Anesth Essays Res. 2018 Oct-Dec;12(4):825-831. doi: 10.4103/aer.AER_142_18.

  PMID: 30662115 BACKGROUND

• Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.

  PMID: 29522966 BACKGROUND

• Tulgar S, Senturk O. Ultrasound guided Erector Spinae Plane block at L-4 transverse process level provides effective postoperative analgesia for total hip arthroplasty. J Clin Anesth. 2018 Feb;44:68. doi: 10.1016/j.jclinane.2017.11.006. Epub 2017 Nov 14. No abstract available.

  PMID: 29149734 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

• 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

• Lin DY, Morrison C, Brown B, Saies AA, Pawar R, Vermeulen M, Anderson SR, Lee TS, Doornberg J, Kroon HM, Jaarsma RL. Pericapsular nerve group (PENG) block provides improved short-term analgesia compared with the femoral nerve block in hip fracture surgery: a single-center double-blinded randomized comparative trial. Reg Anesth Pain Med. 2021 May;46(5):398-403. doi: 10.1136/rapm-2020-102315. Epub 2021 Feb 26.

  PMID: 33637625 BACKGROUND

• Del Buono R, Padua E, Pascarella G, Soare CG, Barbara E. Continuous PENG block for hip fracture: a case series. Reg Anesth Pain Med. 2020 Oct;45(10):835-838. doi: 10.1136/rapm-2020-101446. Epub 2020 Aug 12.

  PMID: 32796133 BACKGROUND

• Roy R, Agarwal G, Pradhan C, Kuanar D. Total postoperative analgesia for hip surgeries, PENG block with LFCN block. Reg Anesth Pain Med. 2019 Mar 28:rapm-2019-100454. doi: 10.1136/rapm-2019-100454. Online ahead of print. No abstract available.

  PMID: 30923252 BACKGROUND

• Kukreja P, Schuster B, Northern T, Sipe S, Naranje S, Kalagara H. Pericapsular Nerve Group (PENG) Block in Combination With the Quadratus Lumborum Block Analgesia for Revision Total Hip Arthroplasty: A Retrospective Case Series. Cureus. 2020 Dec 23;12(12):e12233. doi: 10.7759/cureus.12233.

  PMID: 33500856 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of anesthesia, intensive care and pain management

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: July 5, 2023
• Study Start: February 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

EG (1)