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Peri-capsular Nerve Group Block Versus Fascia Iliaca Block for Hip Arthroplasty

Primary Purpose

Post Operative Pain Management

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pericapsular nerve group block
Fascia Iliaca BLock
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain Management

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled for hip replacement surgeries e.g. hip hemiarthroplasty, total hip arthroplasty under subarachnoid block (SAB)

Exclusion Criteria:

  • Coagulopathy
  • infection at the injection site
  • allergy to local anesthetics
  • severe cardiopulmonary disease (≥ASA IV)
  • diabetic or other neuropathies
  • patients receiving opioids for chronic analgesic therapy
  • contraindication to spinal anesthesia
  • inability to comprehend visual analog scale (VAS).

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

FIB

PENG

Arm Description

hip fracture with fascia Iliaca block

Hip fracture with Pericapsular nerve group block

Outcomes

Primary Outcome Measures

morphine consumption
total morphine consumption over 24 hours

Secondary Outcome Measures

pain scale Visual analogue Scale
Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
muscle power
Assessment of quadriceps femoris muscle strength: For motor block assessment, the patient will be in supine position and the patient's knee will be fully flexed, and the patient will be asked to extend it. The motor block is classified as follows: grade 0; normal muscle power, grade I; motor weakness, grade II; complete motor paralysis

Full Information

First Posted
December 18, 2018
Last Updated
December 19, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03783247
Brief Title
Peri-capsular Nerve Group Block Versus Fascia Iliaca Block for Hip Arthroplasty
Official Title
Pericapsular Nerve Group Block Versus Fascia Iliaca Block for Hip Arthroplasty: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2019 (Anticipated)
Primary Completion Date
May 31, 2019 (Anticipated)
Study Completion Date
June 20, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study, the investigator will examine the efficacy of Pericapsular nerve group (PENG) block in hip surgeries as a post-operative pain management technique in comparison with fascia Iliaca block in hip surgeries
Detailed Description
Hip fracture is a common orthopedic emergency in the elderly, and it is associated with significant morbidity and mortality.1 Surgical reduction and fixation are the definitive treatment in most patients.2 Effective perioperative analgesia that minimizes the need for opioids and related adverse effects (such as delirium) is essential in this patient population. Regional analgesic techniques, including femoral nerve (FN) block, fascia iliaca block (FIB), and 3-in-1 FN block, are popular analgesic strategies, due mainly to their opioid-sparing effects and reduction in opioid-related adverse effects. The effect size of analgesia from these blocks is only moderate, and literature suggests that the obturator nerve (ON) is not covered. The anterior hip capsule is innervated by the ON, accessory obturator nerve (AON), and FN as reported by previous anatomic studies. The anterior capsule is the most richly innervated section of the joint, suggesting these nerves should be the main targets for hip analgesia. A recent anatomical study by Short et al15 confirmed the innervation of the anterior hip by these 3 main nerves but also found that the AON and FN play a greater role in the anterior hip innervation than previously reported. This study also identified the relevant landmarks for those articular branches. The high articular branches from FN and AON are consistently found between the anterior inferior iliac spines (AIIS) and the iliopubic eminence (IPE), whereas the ON , close to the inferomedial acetabulum. Using this information, the investigator developed an ultrasound-guided technique for blockade of these articular branches to the hip, the PENG (PEricapsular Nerve Group) block. In this study, the investigator will examine the efficacy of PENG block in hip surgeries as a post-operative pain management technique in comparison with fascia Iliaca block in hip surgeries

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized double-blinded
Masking
ParticipantOutcomes Assessor
Masking Description
To achieve double blinding, patients will receive the block by the anesthetist. Another doctor not involved in the block procedure will evaluate the patients postoperatively.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FIB
Arm Type
Experimental
Arm Description
hip fracture with fascia Iliaca block
Arm Title
PENG
Arm Type
Experimental
Arm Description
Hip fracture with Pericapsular nerve group block
Intervention Type
Procedure
Intervention Name(s)
Pericapsular nerve group block
Other Intervention Name(s)
PENG
Intervention Description
The regional block was performed with the patient in the supine position. A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees (Figs. 2, 3). In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 80-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution (20ml of bupivacaine 0.25%) was injected in 5-mL increments while observing for adequate fluid spread in this plane for a total volume of 30 mL
Intervention Type
Procedure
Intervention Name(s)
Fascia Iliaca BLock
Other Intervention Name(s)
FIB
Intervention Description
In supine position, a high frequency linear probe will be placed in the inguinal crease. Scan starting laterally from the femoral artery and nerve in inguinal crease to identify the sartorius muscle, tracing the muscle until it's origin to anterior superior iliac spine. The shadow of the bony of iliac crest & iliacus muscle will be seen, the end point of the injection is deep to the fascia iliaca and above the iliacus muscle in the lateral part of the iliacus muscle. After negative aspiration, 30 mL of 0.25 % of bupivacaine will be injected under the fascial plane incrementally, aspirating every 5 ml.
Primary Outcome Measure Information:
Title
morphine consumption
Description
total morphine consumption over 24 hours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
pain scale Visual analogue Scale
Description
Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Time Frame
24hours
Title
muscle power
Description
Assessment of quadriceps femoris muscle strength: For motor block assessment, the patient will be in supine position and the patient's knee will be fully flexed, and the patient will be asked to extend it. The motor block is classified as follows: grade 0; normal muscle power, grade I; motor weakness, grade II; complete motor paralysis
Time Frame
24 HOURS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for hip replacement surgeries e.g. hip hemiarthroplasty, total hip arthroplasty under subarachnoid block (SAB) Exclusion Criteria: Coagulopathy infection at the injection site allergy to local anesthetics severe cardiopulmonary disease (≥ASA IV) diabetic or other neuropathies patients receiving opioids for chronic analgesic therapy contraindication to spinal anesthesia inability to comprehend visual analog scale (VAS).
Facility Information:
Facility Name
Cairo University
City
Cairo
State/Province
Giza
ZIP/Postal Code
1234
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Peri-capsular Nerve Group Block Versus Fascia Iliaca Block for Hip Arthroplasty

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