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Pericapsular Nerve Group Block vs Femoral Nerve Block for Perioperative Pain Management in Patients With Hip Fracture.

Primary Purpose

Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PENG block
FN block
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Femoral nerve, Pericapsular nerve group, Pain, Hip fracture

Eligibility Criteria

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

Inclusion Criteria: Patients with a hip fracture. Aged 50 years and older. Exclusion Criteria: Consent refusal. Allergy to local anaesthetics. Infection of the puncture site. Dementia or cognitive impairment.

Sites / Locations

  • Beni-Suef University hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PENG block group

FN block group

Arm Description

using ultrasound-guided technique, a total of 20ml of 0.25 % bupivacaine will be injected after negative aspiration.

using ultrasound-guided technique, after negative aspiration, 20 mL of 0.25 % bupivacaine will be administered.

Outcomes

Primary Outcome Measures

Quadriceps muscle strength in recovery.
Quadriceps muscle strength will be assessed using Oxford muscle strength grading with grouped scores of intact (5/5), reduced (1-4/5) and absent (0/5). Muscle Grading Scores: 0 No detectable muscle contraction (visible or palpation) Detectable contraction (visible or palpation), but no movement achieved Limb movement achieved, but unable to move against gravity Limb movement against resistance of gravity Limb movement against gravity and external resistance Normal strength

Secondary Outcome Measures

Visual analogue scale
before and 30 minutes after the block both at rest and during dynamic hip movement. 0 means no pain 10 means the worst pain

Full Information

First Posted
July 11, 2023
Last Updated
July 25, 2023
Sponsor
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT05961436
Brief Title
Pericapsular Nerve Group Block vs Femoral Nerve Block for Perioperative Pain Management in Patients With Hip Fracture.
Official Title
Pericapsular Nerve Group (PENG) Block Versus Femoral Never Block for Perioperative Pain Management in Patients With Hip Fracture: A Prospective Randomized Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef 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
The aim of this work is to compare between the use of PENG block and femoral nerve block for perioperative pain management in patients with hip fracture.
Detailed Description
Hip fractures are common orthopaedic problem especially in elderly population which is associated with significant morbidity and mortality. Early surgical reduction and fixation is the preferred treatment in most patients. Significant pain, if inadequately controlled, can impair early rehabilitation and functional recovery and can reduce patient satisfaction after surgery . Combinations of systemic analgesics, intra-articular injection, and neuraxial and peripheral nerve blocks should be considered as the integral components of the perioperative pain management plan. Among these, intra-articular local anaesthetic injections have been shown to play a potential role in providing analgesia after hip arthroplasty. The risks of this procedure include hematoma, nerve damage, local anaesthetics toxicity, intravenous injection of local anesthetics and septic osteoarthritis, but their occurrence is very rare. Several peripheral nerve blocks, including fascia iliaca block, femoral block (FB), and some interfascial plane blocks such as quadratus lumborum block (QLB), have also been suggested to decrease postoperative pain and opioid use. Lumbar plexus block/psoas compartment block is a technically difficult deep block that requires greater skill and hence can be time consuming. The lumbar paravertebral region is highly vascular and non-compressible. Hence, patients on anti-coagulation are at high risk for bleeding complications. There is also high risk of unintentional neuraxial block or inadvertent intravascular injection with local anaesthetic systemic toxicity. Some nerve branches responsible for hip joint innervation may not be blocked by QLB, which should be taken into consideration while using these blocks for hip fracture. High-volume suprainguinal fascia iliaca block and traditional fascia iliaca block have also been reported to be associated with a significant incidence of muscle weakness and to predispose the patient to fall. The anterior hip capsule is innervated by the obturator nerve (ON), accessory obturator nerve (AON), and femoral nerve (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. Femoral block (FB) does not block the AON or the articular branches of the ON. Also, femoral nerve block accompanied by decreasing the strength of quadriceps muscles. Pericapsular nerve group (PENG) block was described in 2018 and reported that it was successfully used for postoperative pain management in hip surgery. The PENG block is a technique that involves deposition of local anaesthetic in the musculofascial plane between the psoas muscle and the superior pubic ramus for the blockade of the articular branches of the FN, ON and AON that provide sensory innervation to the anterior hip capsule.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Femoral nerve, Pericapsular nerve group, Pain, Hip fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PENG block group
Arm Type
Active Comparator
Arm Description
using ultrasound-guided technique, a total of 20ml of 0.25 % bupivacaine will be injected after negative aspiration.
Arm Title
FN block group
Arm Type
Active Comparator
Arm Description
using ultrasound-guided technique, after negative aspiration, 20 mL of 0.25 % bupivacaine will be administered.
Intervention Type
Procedure
Intervention Name(s)
PENG block
Intervention Description
Using ultrasound-guided technique, a total of 20ml of 0.25 % bupivacaine will be injected after negative aspiration.
Intervention Type
Procedure
Intervention Name(s)
FN block
Intervention Description
Using ultrasound-guided technique, after negative aspiration, 20 mL of 0.25 % bupivacaine will be administered.
Primary Outcome Measure Information:
Title
Quadriceps muscle strength in recovery.
Description
Quadriceps muscle strength will be assessed using Oxford muscle strength grading with grouped scores of intact (5/5), reduced (1-4/5) and absent (0/5). Muscle Grading Scores: 0 No detectable muscle contraction (visible or palpation) Detectable contraction (visible or palpation), but no movement achieved Limb movement achieved, but unable to move against gravity Limb movement against resistance of gravity Limb movement against gravity and external resistance Normal strength
Time Frame
24 hours of the procedure
Secondary Outcome Measure Information:
Title
Visual analogue scale
Description
before and 30 minutes after the block both at rest and during dynamic hip movement. 0 means no pain 10 means the worst pain
Time Frame
24 hours of the procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a hip fracture. Aged 50 years and older. Exclusion Criteria: Consent refusal. Allergy to local anaesthetics. Infection of the puncture site. Dementia or cognitive impairment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dina M Fakhry, MD
Phone
201289998680
Email
dina_fakhry_91@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina M Fakhry
Organizational Affiliation
Beni-Suef University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beni-Suef University hospital
City
Banī Suwayf
State/Province
Beni-Suef
ZIP/Postal Code
62814
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dina M Fakhry, MD
Phone
0201289998680
Email
dina_fakhry_91@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

Pericapsular Nerve Group Block vs Femoral Nerve Block for Perioperative Pain Management in Patients With Hip Fracture.

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