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

December 27, 2023 updated by: Ibrahim Walash, Menoufia University

Analgesic Efficacy of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Menoufia, Egypt
        • Menoufia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: L-ESPB and PENG
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
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
Active Comparator: Group B: conventional analgesia
receiving postoperative conventional analgesia in form of acetaminophen 15 mg/kg/6hrs
Drug: Postoperative conventional analgesia in form of Acetaminophen
Postoperative conventional analgesia in form of acetaminophen 15 mg/kg/6hrs
Other Names:
  • Conventional analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at 1 hour after the block
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)
at 3 hour after the block
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)
at 6 hour after the block
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)
at 12 hour after the block
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)
at 24 hour after the block

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first analgesic administration
Time Frame: 24 hours postoperative
Time to first analgesic administration
24 hours postoperative
Vital signs
Time Frame: assessed at preoperative, postoperative (0,3,6,12,24 hours), Value is averaged of total measurements
Heart Rate
assessed at preoperative, postoperative (0,3,6,12,24 hours), Value is averaged of total measurements
Vital signs
Time Frame: assessed at preoperative, postoperative (0,3,6,12,24 hours), Value is averaged of total measurements
Arterial Blood Pressure
assessed at preoperative, postoperative (0,3,6,12,24 hours), Value is averaged of total measurements
Vital signs
Time Frame: assessed at preoperative, postoperative (0,3,6,12,24 hours), Value is averaged of total measurements
Arterial Oxygen Saturation
assessed at preoperative, postoperative (0,3,6,12,24 hours), Value is averaged of total measurements
Total Analgesic Requirements
Time Frame: 24 hours postoperative
Total analgesic requirements in 24 hours postoperative
24 hours postoperative
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.
24 hours after the block
Adverse events
Time Frame: 24 hours after the block
Either hematoma, infection, postoperative nausea, vomiting orlocal anesthetic systemic toxicity
24 hours after the block
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)
1 hour after the block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

June 4, 2023

First Submitted That Met QC Criteria

June 24, 2023

First Posted (Actual)

July 5, 2023

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lumbar ESPB and PENG block

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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