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

NCT ID: NCT05930171

Last Updated: 2023-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Hip surgeries are very common surgeries and has high postoperative pain potential. There are different ways to execute postoperative analgesia and each of them has advantages and disadvantages. As the patients submitted to this procedure are usually older and with multiple comorbidities, analgesia options with better profile of adverse effects should be preferred. Peripheral nerve block with long-acting local anesthetics is very suitable in this situation, in comparison with systemic or neuraxial opioids.

Pain control after total hip arthroplasty (THA) can be challenging because of complex innervation of the hip joint from both the lumbar and sacral nerve plexus. pain was the cause of 12% of unplanned hospital patient admissions, 60% of these patients were admitted for orthopedic concerns. The consequences of severe postoperative pain are prolonged hospital stay, increase hospital readmission, precipitation in the use of opioids with subsequent increase in postoperative nausea and vomiting, and overall low patient satisfaction. Furthermore, postoperative pain can seriously impact the physical and mental health of the patient and lead to secondary complications such as nausea, vomiting, slowed bowel movements, muscle spasms, thrombosis, cardiopulmonary complications and delayed recovery of organ functions.

The hip joint is innervated by the articular branches of multiple nerves that emerge from the lumbosacral plexus (L2-S1). The nerve supply to a specific region of the joint typically corresponds to the innervation of the muscle that crosses it :-

* The femoral nerve innervates the anterior aspect
* The obturator nerve supplies the inferior aspect
* The superior gluteal nerve supplies the superior aspect
* The nerve to the quadratus femoris innervates the posterior aspect.

Hip joint capsular innervation was found to consistently involve the femoral and obturator nerves, which supply the anterior capsule, and the nerve to the quadratus femoris, which supplies the posterior capsule.

Lumbar erector spinae plane block (LESPB) local anesthetics spread to lumbar paravertebral space and lumbar nerve roots, reaching the nerves responsible for the innervation of the hip joint lumbar plexus nerves - femoral, obturator and lateral femoral cutaneous nerves - providing analgesia for hip surgery. LESPB can be a block easier to perform than other options for hip surgery analgesia, such as posterior lumbar plexus.

(L-ESPB) is an effective analgesic technique after hip surgeries. However, an insufficient sensorial blockade of the medial part of the thigh which is innervated by the obturator nerve.

The pericapsular nerve group (PENG) block is an ultrasound-guided approach, first described by Giron-Arango et al. for the blockade of the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule. It has been successfully used as an alternative regional anaesthesia technique for the management of acute pain after hip fracture, but its applications are expanding, suggesting a potential role for analgesia after elective hip surgery.

After all the investigators hypothesize that combination of LESPB and PENG block can be more effective in pain control after hip surgeries.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A: L-ESPB and PENG

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

Group Type ACTIVE_COMPARATOR

Ultrasound guided L-ESPB and PENG block using Bupivacaine

Intervention Type PROCEDURE

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

Group B: conventional analgesia

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

Group Type ACTIVE_COMPARATOR

Postoperative conventional analgesia in form of Acetaminophen

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasound guided L-ESPB and PENG block using Bupivacaine

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

Intervention Type PROCEDURE

Postoperative conventional analgesia in form of Acetaminophen

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lumbar Erector Spinae Plane Block and Pericapsular Nerve Group Block Conventional analgesia

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Menoufia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ibrahim Walash

Assistant Lecturer of anesthesia, intensive care and pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Menoufia university

Menoufia, Menoufia, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 32158307 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30871306 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30662115 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29522966 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29149734 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30063657 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33432791 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33637625 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32796133 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30923252 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33500856 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Lumbar ESPB and PENG block

Identifier Type: -

Identifier Source: org_study_id