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Completed

NCT Number: NCT05930171

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Menoufia university

Menoufia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Lumbar Erector Spinae Plane Block and Pericapsular Nerve Group Block

Postoperative conventional analgesia in form of Acetaminophen

Drug

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

Other names: Conventional analgesia

Primary outcomes

  1. Postoperative pain intensity

    Time frame: at 1 hour after the block

    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)

  2. Postoperative pain intensity

    Time frame: at 3 hour after the block

    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)

  3. Postoperative pain intensity

    Time frame: at 6 hour after the block

    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)

  4. Postoperative pain intensity

    Time frame: at 12 hour after the block

    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)

  5. Postoperative pain intensity

    Time frame: at 24 hour after the block

    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)

Secondary outcomes

  1. Vital signs

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

    Heart Rate

  2. Vital signs

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

    Arterial Blood Pressure

  3. Vital signs

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

    Arterial Oxygen Saturation

  4. Time to first analgesic administration

    Time frame: 24 hours postoperative

    Time to first analgesic administration

  5. Total Analgesic Requirements

    Time frame: 24 hours postoperative

    Total analgesic requirements in 24 hours postoperative

  6. Patient satisfaction

    Time frame: 24 hours after the block

    patients will be asked to assess their satisfaction :-

    • I Very satisfied.
    • II sometimes satisfied.
    • III Neither satisfied nor dissatisfied.
    • IV Somewhat dissatisfied.
    • V Very dissatisfied.
  7. Adverse events

    Time frame: 24 hours after the block

    Either hematoma, infection, postoperative nausea, vomiting orlocal anesthetic systemic toxicity

  8. Block failure (patients still feeling pain immediately after 1 hour from block)

    Time frame: 1 hour after the block

    Block failure (patients still feeling pain immediately after 1 hour from block)

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 5, 2023
Registry last updated
Dec 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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