Clinical trial NCT05930171: Combined Lumbar Erector Spinae Plane Block and Pericapsular Nerve Group Block in Patients Undergoing Hip Surgeries
Official title: Analgesic Efficacy of Combined Lumbar Erector Spinae Plane Block and Pericapsular Nerve Group Block in Patients Undergoing Hip Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative pain intensity
timeFrame: at 1 hour after the block
measure: Postoperative pain intensity
timeFrame: at 3 hour after the block
measure: Postoperative pain intensity
timeFrame: at 6 hour after the block
measure: Postoperative pain intensity
timeFrame: at 12 hour after the block
measure: Postoperative pain intensity
timeFrame: at 24 hour after the block
Secondary outcomes:
measure: Vital signs
timeFrame: assessed at preoperative, postoperative (0,3,6,12,24 hours), Value is averaged of total measurements
measure: Vital signs
timeFrame: assessed at preoperative, postoperative (0,3,6,12,24 hours), Value is averaged of total measurements
measure: Vital signs
timeFrame: assessed at preoperative, postoperative (0,3,6,12,24 hours), Value is averaged of total measurements
measure: Time to first analgesic administration
timeFrame: 24 hours postoperative
measure: Total Analgesic Requirements
timeFrame: 24 hours postoperative
measure: Patient satisfaction
timeFrame: 24 hours after the block
measure: Adverse events
timeFrame: 24 hours after the block
measure: Block failure (patients still feeling pain immediately after 1 hour from block)
timeFrame: 1 hour after the block
Other outcomes:
Locations:
city: Menoufia
country: Egypt
facility: Menoufia university
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.